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Challenges facing European Pharmaceutical Manufacturers in 2022

Pharmacentral Reporters

In the run-up to Christmas, there was considerable anxiety about shortages of all sorts of goods, from toys, food, and medical supplies. These were down to supply chain pinch points, exacerbated by the global pandemic, and multiple other factors that all came to a head in Q3 and 4.

As Europe settles into 2022, pharmaceutical manufacturers are a vertical that face specific challenges. We polled representatives from across the sector, from CROs, CDMOs, generic and R&D intensive manufacturing companies. Here are the highlights of what we found out.

Supply chains

The Covid-19 pandemic has affected every part of the manufacturing value chain, from raw material to end customers. Companies are reporting continued disruptions in global logistics which are impacting the flow of raw materials and goods due to congestion and shutdowns at major global ports and airports, largely in China, South Korea, and the US.

As the year progresses, these disruptions will lessen, and access to sea and airfreight will improve back to pre-pandemic levels, but companies can still expect to see higher input prices (as excessive freight costs are passed on), and longer lead times because of the length it takes to clear logjams in the supply chain.

Sustainability goals

COP26 has provided new impetus for action on sustainability, and many companies have committed to ambitious goals. Turning these commitments into tangible goals requires companies to work with suppliers that adhere to social and environmental standards. However, firms face special challenges governing lower-tier suppliers (lower down the value chain) due to absence of direct contractual relationships. Often, lower-tier suppliers are the least equipped to handle sustainability requirements.

Skilled labour shortages

Having a qualified workforce is essential to ensuring the high levels of quality required in the pharmaceutical industry are met. However, many companies are reporting shortages, both for white and blue collared workers, in terms of both skills and numbers. Uncertainties over the last years have exacerbated shortages but there are several other non-COVID-19 related factors at play, including changes in demographics.

Manufacturing flexibility

As the past two years have demonstrated, resilience is predicated on agility and adaptability rather than impregnability. In order to rapidly respond to evolving market dynamics, pharmaceutical manufacturers need to transform their manufacturing models into those that are flexible, using production methods designed to easily adapt to changes in the type and quantity of the product being manufactured. However, while desired, flexibility is not that easy to pull off in a highly regimented sector that is pharma. Changes to decades-old and established methodologies require fresh and expensive regulatory scrutiny. Importantly, new, and specialised machinery need to be purchased and installed to allow for this level of customization, and not every firm has access to finance or the manpower to achieve this transformation within the needed timelines.

Final thoughts

The pandemic has brought to the fore the vulnerabilities of European pharmaceutical market. Issues such as supply chain are transient whereas changing demographics, mainly from aging and retiring workers, as well as border and immigration controls, are structural. Going forward, it will be necessary to formulate a suitable policy mix to address these challenges.


  1. GlobalData, 2021. COVID-19: Contract Pharmaceutical Development and Manufacturing Relationships. [online]. Available at:
  2. CPhI, 2021. Pharma Trends 2022. [online] CPhI, pp.6-7, 16. Available at…[Accessed 10 January 2022].

January 2022 CHMP Meeting Highlights

The CHMP is the European Medicines Agency’s (EMA) committee responsible for human medicines. It plays a key role in authorisation of medicines in the European Union. The CHMP meets once a month to exercise its duties. Click here to download CHMP’s meeting dates.

In its latest meeting, CHMP recommended seven new medicines for approval, including the antiviral Paxlovid (PF-07321332/ritonavir) for COVID-19 and Breyanzi (lisocabtagene maraleucel), a gene therapy for large B-cell lymphomas.



PAXLOVID™ (Nirmatrelvir and Ritonavir) – Pfizer

The committee recommended granting conditional marketing authorisation to Paxlovid for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe.

Paxlovid is the first oral antiviral recommended for treating COVID-19 in the EU and contains two active substances, Nirmatrelvir and ritonavir. Nirmatrelvir reduces the ability of SARS-CoV-2 (the virus that causes COVID-19) to multiply in the body while ritonavir prolongs the action of Nirmatrelvir.

The decision was based on trial results in which Paxlovid significantly reduced hospitalisations or deaths in patients who have at least one underlying condition putting them at risk of severe COVID-19. Over the month following treatment, the rate of hospitalisation or death was 0.8 percent (8 out of 1,039) for Paxlovid recipients and 6.3 percent (66 out of 1,046) for placebo. There were no deaths with Paxlovid and 12 deaths in the placebo group.


BREYANZI® (Lisocabtagene maraleucel) – Bristosl Myers Squibb

BREYANZI® is an immune-cell-based gene therapy. A patient’s T cells are extracted and genetically engineered to express a chimeric antigen receptor (CAR) protein that allows them to target and eliminate cancer cells, before being reinfused in the patient.

Breyanzi had PRIME designation and benefited from early and enhanced dialogue between the EMA and its developers. A positive opinion was given to Breyanzi for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) after at least two previous lines of treatment.

The CHMP based the decision on the safety of Breyanzi, examined in four studies involving over 300 treated patients, and the efficacy in two studies pooling about 350 patients. The efficacy trials concluded that clinical benefit would be expected with a meaningful disease control in a substantial proportion of patients.

Biosimilars and Generics

CHMP adopted a positive opinion, and recommended the granting of marketing authorisations for the following biosimilars/generics:

Sondelbay (Teriparatide) for the treat osteoporosis and Stimufend (Pegfilgrastim) for the reduction of the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy were the two biosimilars that received recommendations for approval.

Dasatinib Accord (Dasatinib) for the treatment of leukaemia, and Vildagliptin/Metformin hydrochloride for the treatment of type 2 diabetes. Dasatinib Accord is a generic of Sprycel, which has been authorised in the EU since 20 November 2006.

Indication Extensions

Eight medicines were recommended for indication extensions, namely Ayvakyt, Briviact, Dupixent, Jardiance, Lacosamide, Senshio, Tecfidera and Vimpat.

Miscellaneous Actions

Rotterdam Biologics B.V., the applicant for Ipique (Bevacizumab) requested a re-examination of the committee’s earlier opinion not to grant an authorisation.

CHMP completed a review of Nasolam (Midazolam, Nasal spray) and concluded that the benefits of this medicine outweigh its risks and that marketing authorisations should be granted in those Member States of the EU where the company has applied.

CHMP concluded, following it’s review of Stresam (Etifoxine), that the medicine can continue to be used for the treatment of anxiety disorders but must not be used in patients who previously had severe skin reactions or severe liver problems after taking etifoxine.

Development of a Novel Coating for Conventional Non-Functional Applications

Yasuhiro Suzuki and Tatsuya Suzuki

Faculty of Pharmaceutical Science, Toho University


Despite the wide availability of alternative formats, solid dosage forms remain the most efficient methods for delivering drug substances into the body. Tablets and capsules are comparatively easy to manufacture, being relatively fast and easy to form, and from the consumer’s perspective, the most preferred approach due to their portability and ease of administration(1).

The vast majority of approved new drug products formulated as solid dosages forms are film coated. Film coatings perform a number of functions, including the following(2):

  • achieve controlled-drug release properties
  • aid identification and reduce medication errors (EU law requires all primary dosage forms to be identifiable to prevent medication errors)
  • delay drug release, for instance, enteric release properties
  • impart aesthetic features (colour & gloss) to allow branding
  • protect sensitive active ingredients from light, moisture or heat
  • mask unpalatable or odoriferous ingredients (e.g. garlic or fish liver oil)

Film Coatings Competitive Landscape

In 2018, the global market for pharmaceutical film coatings was dominated by non-functional coatings. This category accounts for approximately 70% of the total volume output. Functional and modifying coatings account for 14.9% of the annual output, while functional, non-modifying products are responsible for the rest (i.e 13.1%)(3,4). The different percentages are represented in figure 1 below.

In 2010, IMS Health (now IQVIA) estimated that the total global immediate-release film coating excipient market was around 25,000MT p.a. Approximately 65% of this output was supplied as ready-made dry powder mixes, which currently retail at $40.0 per kilo. By comparison, the modified-release film coating excipient market is smaller (approx. 6,000MT p.a). This is based on estimates of 1.7 trillion tablets coated with immediate release coatings compared to just 100 billion for the modified release coatings. Based on these calculations, the total market for pharmaceutical coatings is easily around $1 – 1.2 billion(6).

IR Applications (25,000MT) % MR Applications (3,000MT) % Non-coating Technologies (5,000MT) %
Aesthetics 60.0 Enteric 55.0 Matrix systems 70.0
Moisture Protection 15.0 Sustained release 15.0 Hydrogels 20.0
Taste/odour masking 10.0 Controlled release 28.0 Melt extrusion 5.0
Others 15.0 Others 2.0 Others 5.0

Focussing on non-functional coatings, there are several products currently available on the market. Examples of their main attributes are shown in the table below. All these systems are simple physical mixes of a polymer, a plasticizer, a detackifier and other materials (e.g colours, flavours, etc). Their main use is simple physical coating, applied via aqueous or organic solvent spray coating in heated rotating drums.

Product Eudragit EPO Sepifilm LP Opadry II (85)
Manufacturer Evonik Seppic Colorcon
Base polymer Aminomethacylic acid Hypromellose Poly(vinyl) alcohol
Other components Only base polymer is supplied Stearic acid, Talc & MCC Lecithin, PEG & Talc
Regulatory status Pharmaceuticals, Global coverage. Not food approved Both food, nutraceuticals & pharmaceuticals approval, Global coverage Not food approved. Pharmaceutical approval – Global coverage
Ease of use Very complex, multi-step preparation requiring detailed formulation & storage One-step preparation & application process. Approx. 45min preparation One-step preparation & application process. Approx. 45min preparation
Personalization Possible Possible Possible
Coating process time Fast (1 hr for 1 MT batch) Slow (2-3 hrs for 1 MT batch) Fast (1 hr for 1 MT batch)
Cost (/kg) $30 $35 $40

A list of existing suppliers and potential collaborators for this project is shown below:


# Name Comment
1 Biogrund GmbH

Small supplier of ready-made systems based in Germany. Recent alliance with Roquette may improve market standing and penetration. Currently focussed on Northern & Eastern Europe.


Limited supplier of ready-made systems. Main experience is in the development of polymers with the most recent ones being copies of Evonik pharmaceutical coating polymers. They have an immediate release polymer – PVA-PEG co-grafted polymer. Strength is in their polymer technical expertise. They are poor at supporting the sales and marketing of their products.

3 Colorcon*

Largest supplier of ready-made film coating systems globally. Not a polymer manufacturer but alliance with Dow provides a lower cost source of polymers. Colorcon have approximately 60% global market share in Immediate Release coating systems.

4 Evonik*

Specialists in development of coating polymers. They are technically very strong but do not get involved in manufacturing ready-made coating systems. They have an alliance with Colorcon to provide polymers for a fully pigmented enteric coating systems. They are the strongest supplier for enteric and sustained release coating systems.

5 Dupont (ex FMC Biopolymer)

Do not supply any pigmented film coating systems and do not have capability or current wish to provide this service. Only coating for Immediate Release is Lustre Clear – which has proved to be unsuccessful in the market place.

6 Ashland*

Formerly known as Hercules/ISP. Manufacture their own polymers and have set up colour matching and coating laboratories around the world. They are positioning themselves to take Colorcon on as a primary supplier of ready made, pigmented coating systems. One of the few companies who have a global sales and technical network

7 Ideal Cures

An Indian supplier of ready-made coating systems trying to break-out of their home market. Most success outside of India has been in the supply of coatings for nutritionals and to small generic companies in South Asian market.

9 Sensient

ex Warner Jenkinson. They do not supply complete film coating systems and since the company focus back to the US they have lost market share and company focus.

10 Seppic

French-based supplier of ready made film coating systems. Limited sales penetration with focus mainly in Southern Europe


Objectives of this work

The main objective of this work was to develop a conventional, non-functional coating system with demonstrable enhanced ease of use and minimal impact on dissolution rate and stability of model drug substances.

Research Methodology

 The approach taken to research and develop the new coating product is described below:

Coating formulation development

The initial work involved developing prototype formulations of the coating. This entailed screening three commonly used polymers, i.e poly(vinyl alcohol) 88% doh; aminomethacylic acid copolymer (Eudragit E) and hypromellose to which the required quantities of inclusives has been added, in accordance with the established practice of pharmaceutical coatings formulation. The representative formulae are shown below:

Standard Formulae adopted for screening coating systems (amounts in %)

Poly(vinyl alcohol) Aminomethacrylate Hypromellose
Polymer 40-80 40-80 40-80
Plasticizer 1-10 1-10 1-10
Surfactant 0-2 1-10 1-5
Carbohydrate 0-10 0-10 0-10
Bulking agent 1-10 5-20
Other materials 0-5 0-5 0-5


In addition, commercially available coating products, i.e Sepifilm (hypromellose-based); Opadry (poly(vinyl alcohol) based and Eudragit EPO (aminomethacrylate copolymer – based) were prepared in accordance with their respective vendor instructions and used as comparators in this work. Methods of preparation and coating are widely reported in the literature and will not be repeated here.

A list of materials and their purposes is provided in the table below:

# Name Purpose
1 Polaxamer Surfactant/wetting agent
2 Magnesium stearate Hydrophobicity enhancer
3 Stearic acid Surfactant/plasticizer
4 Stearamide Plasticizer
5 Lecithin Surfactnat/plasticizer
6,7,8 Guar gum, Pectin & Xanthan gum Extender
9 Starch Filler
10 Polyethylene glycol (400, 1000, 3350) Plasticizer
11 Polypropylene glycol Plasticizer
12 Triethyl citrate Plasticizer
13 Glycerol monostearate Plasticizer
14 Sodium lauryl sulphate Surfactant
15 Polysorbate 80 Surfactant
16 Talc Filler
17 Titanium dioxide Colorant/Filler
18 Microcrystalline cellulose Filler/Extender
19 Trehalose Extender/Filler
20 Glycerol Plasticizer
21 Erythritol Plasticizer
22 Calcium carbonate Filler


A series of formulations was then developed using the above-listed compounds in accordance with the standard coating formulae, also listed above. Cast films were made from dispersions prepared using aqueous media of the different formulations and evaluated for various features to determine which products presented the best chances of being used as coatings. The tests ranged from tensile tests, moisture uptake/desorption, water vapour transmission rates, colour consistency and tackiness. Only films judged as acceptable/meeting set criteria were selected for further evaluation/development.

Tablet coating trials

Coating trials were undertaken in a laboratory scale Aeromatic Fielder fluid bed coater. Conditions of the test varied depending on the coating under consideration. The aim, however, was to obtain a standardized weight gain of 3-4% for each product, so the conditions were continuously adjusted to meet this criteria. Study tablet cores were made with Diltiazem hydrochloride (30%) and lactose and were compressed to achieve a fill weight of 200mg. Other materials added included magnesium stearate (0.5%); microcrystalline cellulose (15%), pregelatinized starch (15%) and aerosol (0.1%). Cores which were successfully coated were subsequently evaluated for drug release properties (in addition to the usual pharmacopoeial QC tests) which for brevity are not shown.

Dissolution (drug release) testing

Automated dissolution test were performed on diltiazem HCl tablets (30mg) due to its high solubility. All tablets coated to levels as for stability samples and test undertaken in HCl (pH 1.6); Na-acetate/ Acetic acid buffer system (pH 4.5) & phosphate buffer (pH 6.8).

Stability studies

To test for stability, three formulations of moisture sensitive drug substances (APIs) were prepared as follows: All quantities shown are %.

Aspirin Enalapril maleate Niacinamide
API 30 5.0 50
Lactose 38.9 63.9 18.9
Stearic acid 1 1 1
Microcrystalline cellulose 15 15 15
Pregelatinized starch 15 15 15
Aerosil 0.1 0.1 0.1
Fill weight 250mg 100mg 500mg


Once prepared, cores were coated with experimental and commercially-available formulations and placed on stability for periods ranging from 3months to 12 months. Conditions were standard USP stability conditions (40C/75% RH) either in a stability chamber or a desiccator containing sodium chloride slurry as the humidity provider.

Samples were removed at regular times (2 weeks, 1 months, 3 months, 6 months, 9 months and 12 months and tested for the amount of drug left after decomposition. The assay methodology was as follows:

Aspirin: RP HPLC using acetonitrile 25%/DI H2O 75% mobile phase. Acidified with 1% orthophosphoric acid (85% w/w). Elution: 1.0ml/min (Isocratic), Column temperature ambient and detection wavelength of 287nm. Both peaks for aspirin and salicylic well resolved.

Enalapril: RP HPLC using acetonitrile 25%/phosphate buffer 75% mobile phase. Buffer prepared from sodium dihydrogen phosphate (NaH2PO4) 10mM (adjusted to pH 2.2 with orthophosphoric acid 85% w/w). Elution: 1.5ml/min (Isocratic), Column temperature of 60C and detection wavelength of 215nm. All peaks well resolved.

Niacinamide: Two methods used: USP assay by simple UV at 450nm and RP HPLC (c18 column) using methanol 15%/DI H2O as mobile phase (+ 0.005M heaptanesulfonic acid and 0.5M triethylamine). Elution: 2.0ml/min (Isocratic), Column temperature of ambient and detection wavelength of 280nm. Peaks well resolved.


The results shown below are for the most promising formulation out of 4 candidates developed so far. This specific prototype was prepared using the following formula:

Purpose %
Aminomethacylate copolymer Base polymer With held
Pectin Extender/adherent With held
Stearamide or cholesterol Surfactant/plasticizer With held
Talc Filler With held
Polaxamer F127 Surfactant With held



As shown below, there are differences in dissolution profiles depending on the medium being used. It must be emphasized, though, that except those samples coated with Eudragit EPO commercial product, all samples were fast dissolving (90-100% release within 15min).

In HCl, all the five samples dissolve extremely rapidly and in accordance with the requirements for immediate release coated tablets, achieve 100% release well before the mandatory 45 minutes stipulated.

In pH 4.5 acetate buffer, again all the samples were able to achieve 100% release well-within the mandated time. These results were all as expected.

In pH 6.8 phosphate buffer, all the samples with the exception of the Eudragit EPO commercial formulation dissolved rapidly, including the novel formulation which is based on Eudragit EPO. This shows that drug release properties are enhanced with the novel product compared with the commercial formulation.

Stability studies

 Aspirin tablets (75mg)

Following accelerated stability study conditions of 40C/75% RH open dish in sealed/conditioned Sanyo MCO stability chamber (UCLan) or desiccator (validated for RH) in temperature-controlled oven (SOP) the 12-month results (aggregated) are shown below:

Key to the graph: NV – Novel formula; ED – Eudragit EPO; OP – Opadry AMB; SP – Sepifilm LP & CT – Uncoated tablets.

The results show that aspirin samples coated with the commercial formulations significantly decrease in strength over time period of study while the novel formulation is not affected as much as the uncoated samples. This shows that the novel formula does not accumulate moisture within the coating as much as the commercial products so as to cause degradation.

Enalapril Tablets (5mg)

 As in previous case, accelerated stability study conditions of 40C/75% RH open dish placed in sealed/conditioned Sanyo MCO stability chamber (UCLan) or desiccator (validated for RH) in temperature-controlled oven (SOP) for a total 365 days were used. 12-month results (aggregated) are shown below:

Key to the graph: NV – Novel formula; ED – Eudragit EPO; OP – Opadry AMB; SP – Sepifilm LP & CT – Uncoated tablets.

As in aspirin’s case, results for Enalapril also show that samples coated with the commercial formulations significantly decrease in strength over time period of study. Those coated with the novel formulation are not significantly affected and retain their viability to the same extent as the uncoated samples. This shows that the novel formula does not accumulate moisture within the coating as much as the commercial products so as to cause degradation.

Niacinamide Tablets (250mg)

The study conditions were also replicated for Niacinamide and were: 40C/75% RH open dish placed in sealed/conditioned Sanyo MCO stability chamber (UCLan) or desiccator (validated for RH) in temperature-controlled oven (SOP) for a total 365 days. 12-month results (aggregated) are also shown below:

Key to the graph: NV – Novel formula; ED – Eudragit EPO; OP – Opadry AMB; SP – Sepifilm LP & CT – Uncoated tablets.

It can be seen that this time, a mixed picture is obtained, with the uncoated and Sepifilm coated samples showing more degradation than samples coated with Opadry, Eudragit EPO and the Novel formula. On further investigation, it was found that the release of nicotinic acid exacerbated degradation of the remaining niacinamide within the tablets, hence the pictur shown does not necessarily represent the impact of the coatings.


The results show a concept that could be the basis for a unique pharmaceutical coating system. The concept is desirable for the following reasons:

1)         Innovative, scientifically validated approach for elaborating pharmaceutical polymer coatings of superior functionality with a strong scope for IP.

2)        Simplicity and wide applicability of the approach which keeps the risk of the technology not being adopted by customers low but keeping the marketability to potential purchasers high.

3)         Timing and flexibility of the technology in response to environmental and technological concerns regarding the use of solvents in pharmaceuticals.

The results demonstrate proof of principle, even though more work is required to assess scalability.


  1. R.I. Mahato, and A. S. Narang. Pharmaceutical Dosage Forms and Drug Delivery. Routledge, Boca Raton, Fl. pp: 313-335. 2012
  2. Overview of Tablet Coatings –
  3. J. E. Hogan. Film Coating Materials and their Properties. in: G. Cole, J. E. Hogan and M. Aulton. Pharmaceutical Coating Technology. Routledge, Boca Raton, Fl. pp 6-50.
  4. Tablet Film Coatings Market
  5. IMS Health (IQVIA) Internal communication

The United States Pharmacopoeia

The United States Pharmacopeia (or to give it its full name, The United States Pharmacopoeia and the National Formulary (USP–NF) is a pharmacopoeia published by the United States Pharmacopoeial Convention. It is the official compendia of the United States of America.

The USP-NF contains monographs and standards for medicines, finished dosage forms, active drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and many other therapeutic goods intended for use in healthcare.

The United States Pharmacopeial Convention (confusingly also called the USP) is the non-profit organization that owns the trademark and copyright to the USP-NF. It is charged with the responsibility for publishing the USP-NF and managing the process of developing official monographs as well as availing official reference standards.

The USP-NF does not enforce any laws – it merely carries official standards developed by the United States Pharmacopoeial Convention for medical articles manufactured and marketed in the United States. Enforcement is caried out by the U.S. Food and Drug Administration (FDA).


History of the United States Pharmacopoeia

The United States Pharmacopeia traces its origins to the early part of the 19th century. The War of Independence (1775-1783) had exposed the inadequacy of existing standards in controlling medicines required to meet the needs of American military hospitals.

Leading physicians of the time begun collating information on medicinal products and organising it into dispensatories and pharmacopoeias. In 1820, a group of 11 physicians met at the US Capitol in Washington DC, the result of which was the creation of the first United States Pharmacopeia (published as The Pharmacopoeia of The United States of America).

The first editions were very basic, and aimed only to serve as “authoritative” resources for the public to consult. They included a few hundred products that were deemed well understood and characterised at the time.

In 1848, the US Congress passed the Drug Importation Act in response to public outcry about imported patent medicines from Europe, which many felt substandard. This act recognised the United States Pharmacopeia as the official compendia for the United States of America.

Independently of the United States Pharmacopeia, the American Pharmaceutical Association established the National Formulary (NF) in 1888. The NF principally aimed to serve as a resource and a formulary for small-scale compounding of medicines.

In 1906, the Pure Food and Drugs Act further codified the United States Pharmacopeia and National Formulary standards, recognising both compendia for product strength, quality and purity. Subsequent legislation, including the 1938 Federal Food, Drug and Cosmetic Act, further cemented the role of these compendia in standardisation of quality of medicines in US commerce.

In 1975, the United States Pharmacopoeial Convention purchased the right to the National Formulary, bringing together the two compendia under one roof, thus creating the United States Pharmacopoeia-National Formulary that we know today.


Organisation of the United States Pharmacopoeia

Over the years, the USP-NF has evolved, not just in terms of national and international recognition but also in the scope of the information it covers.

Now in its 43rd edition (from May 2021), the current USP-NF remains true to its original mandate: to be an accessible source of information for quality of prescription, nonprescription, and compounded medicines; excipients; biologics; medical devices; and dietary supplements.

Actives are generally featured in the United State Pharmacopoeia section while excipients appear in the National Formulary. If an excipient is also used as an active it will be featured in the United States Pharmacopeia section.

It features close to 5000 monographs, of which there are around 1500 monographs for active ingredients, 450 for excipients, and over 2500 for finished dosage forms.

In addition to monographs, the USP-NF also features 350 “General Chapters” sections, which covers information on assays, tests, and procedures used in monographs.


Available Formats

The print version of the USP-NF is no longer available. The only available format now is online via a subscription.

The online format is highly convenient not only because of the convenience of access but any updates are automatically posted.

The online format also offers improved search functionalities, and moreover you can set alerts as well as bookmarks for pages of interest.


Subscriber Resources



Brinckmann R. M et al (2020). Quality Standards for Botanicals — Legacy of USP’s 200 Years of Contributions. HerbalGram (American Botanical Society) 126: 50-65. Accessed 10.11.2021.


The European Pharmacopoeia

The European Pharmacopoeia (Ph.Eur) is a pharmacopoeia published by the European Directorate for the Quality of Medicines and Healthcare (EDQM) under the auspices of the Council of Europe and all the signatory states to Treaty Number 050. The Ph.Eur is the de facto official pharmacopoeia of the European Union.

Through its monographs and general chapters, the Ph.Eur fosters public health by elaborating and communicating scientifically-valid standards required for assessing and controlling quality of medicines and excipients.

The European Pharmacopoeial Commission is the decision-making body at the EQQM responsible elaboration and maintenance of the Ph.Eur content, including revision and updates of different monographs and general chapters.


History of the European Pharmacopoeia

The Ph.Eur traces its origins to 1963, when the Public Health Committee of the Council of Europe adopted a draft Convention that lay the legal, technical and administrative foundations of the Ph.Eur. The following year, the Committee of Ministers adopted the Convention and the Rules of Procedure that would govern the European Pharmacopoeia Commission.

Between 1965 and 1966, a Technical Secretariat was expanded and a Commission appointed. Three years later, the first edition of the Ph.Eur was published, and contained just over 100 monographs. Six years later in 1975, the European Union adopted Council Directive 75/318/EEC, which made compliance with Ph.Eur monographs mandatory when applying marketing authorisations.

Now in its 10th edition, the Ph.Eur as well as the Convention has 39 signatory parties from across Europe, including the European Union, that participate and vote on sessions of the European Pharmacopoeia Commission.


Legal Framework

Several regulations form the legal basis for the Ph.Eur. They are:


Organisation of the European Pharmacopoeia

The Ph.Eur is arranged into different sections, including

  • General Chapters
  • General Monographs
  • Monographs for Vaccines, Immunosera, Radiopharmaceuticals, Sutures, Herbal products and Homeopathic products
  • Specific monographs on Active Pharmaceutical Ingredients and Excipients, and
  • Specific Monographs on Dosage Forms

The 10th Edition of the Ph.Eur (including Supplement 10.5) contains 2447 monographs (including dosage forms), 378 general texts (including general monographs and methods of analysis) and about 2800 descriptions of reagents.

All these standards are designed to meet the information needs of scientists and managers involved in research and quality control of medicines, regulatory authorities and those involved in the manufacture of medicinal products or individual components.


Available Formats

The Ph.Eur is available as a single reference volume that covers all relevant articles featured. The 10th Edition was released in July 2019 and will be updated with eight periodic supplements over the following three years (10.1 to 10.8).

Available in either English or French, the print version contains a subscription key (EPID code) that allows access to online archives. The compendium can also be accessed online via a licence (individual or shared access).


Subscriber Resources

The 2021 subscriptions to the European Pharmacopoeia Supplements 10.3-10.5 are available on the EDQM WebStore.



The European Medicines Agency: European Pharmacopoeia

Quality standards of the European Pharmacopoeia


2021 saw the successful introduction of COVID-19 Vaccines. Here’s what we learned

Although vaccines have proven to be effective, more is needed if we’re to end the pandemic

Following the approval of Pfizer’s COVID-19 vaccine, we started 2021 full of hope. With vaccines in the supply-chain, the idea was to get shots in people’s arms as quickly as possible, curb the pandemic and get life back to normal. That was the plan then.

12 months on, roughly 9 billion doses have been administered. In the United States, three vaccines—Pfizer-BioNTech, Moderna and Johnson & Johnson — are widely available. Elsewhere, about two dozen other vaccines have also been approved. In many higher-income countries, booster shots have already started to be administered.

But 2021 also gave us a wealth of knowledge about vaccines’ capabilities. With the emergence of aggressive unpredictable variants, inequitable distribution, hesitancy, and the natural course of waning effectiveness, we now know there still remains much work to do to bring this pandemic to an end. As if to hammer home the point, the detection of the Omicron variant in late November brought home the uncertainty of the pandemic’s trajectory.

So here are some of the key lessons we’ve learned in 2021 about COVID-19 vaccines.

COVID-19 vaccines work, even against emerging variants

Many COVID-19 vaccines proved effective over the last year, particularly at preventing severe disease and death. That’s true even with the emergence of more transmissible coronavirus variants.

In January, during a bleak winter surge that saw average daily cases in the United States peak at nearly a quarter a million, the vaccination rollout here began in earnest. Soon after, case numbers began a steep decline.

Over the summer, though, more reports of coronavirus infections in vaccinated people began to pop up. It was this time that we learnt protection against infection becomes less robust several months following vaccination for Pfizer’s or Moderna’s mRNA vaccines. But the vaccines’ original target — preventing hospitalization — remained stable, with an efficacy of between 80 percent to 95 percent.

Studies also showed that a single dose of Johnson & Johnson’s vaccine was less effective at preventing symptoms or keeping people out of the hospital than the mRNA jabs. The company claims, though, that there’s not yet evidence that the protection wanes. But even if that protection is not weakening, some real-world data hint that this vaccine may not be as effective as clinical trials had suggested.

It is against this evidence (of waning protection) that governments ultimately mooted the idea of COVID-19 booster vaccines for adults.

Concern about declining immunity came to a head amid the spread of highly contagious variants, including Alpha, first identified in the United Kingdom in September 2020, and Delta, first detected in India in October 2020. Currently, Delta is the dominant variant globally.

The good news is that vaccinated people aren’t unarmed against these mutated variants. Clinical data has demonstrated that vaccines trigger antibodies that are still able to attack Alpha and Delta, albeit with slightly less intensity than for the original Wuhan variant that emerged out of China two years ago. Antibodies also still recognize more immune-evasive variants such as beta, first identified in South Africa in May 2020, and gamma, identified in Brazil in November 2020. Although protection against infection dips against many of these variants, vaccinated people remain much less likely to be hospitalized compared with unvaccinated people.

Experts will continue to track how well the vaccines are doing, especially as new variants, like Omicron, emerge. In late November, the World Health Organization designated the omicron variant as the latest variant of concern after researchers in South Africa, and warned that it carries several worrisome mutations. Preliminary studies suggest that Omicron can reinfect people who have already recovered from an infection. The variant is at least as transmissible as Delta. We now know that Omicron may affect vaccine effectiveness. Pfizer-BioNTech’s two-dose vaccine, for instance, is about 30 percent effective at preventing symptoms from Omicron infections while a booster could increase effectiveness back up to more than 70 percent, according to estimates from Public Health England.

Vaccines are safe, with few serious side effects

With close to nine billion of doses administered around the world as of year-end, the shots have proved not only effective, but also remarkably safe, with few serious side effects.

Commonly reported side effects include pain, redness or swelling at the spot of the shot, muscle aches, fatigue, fever, chills or a headache. These symptoms usually last only a day or two.

But more rare and serious side effects have also been reported. However, none are unique to these vaccines. In deed other vaccines — and infectious diseases, including COVID-19 — also cause these adverse effects.

One example is myocarditis and pericarditis. Current estimates are a bit fluid since existing studies have different populations and other variables. However, two large studies in Israel estimated that the risk of myocarditis after an mRNA vaccine to about 4 of every 100,000 males and 0.23 to 0.46 of every 100,000 females. Researchers also reported in October in the New England Journal of Medicine. Yet members of Kaiser Permanente Southern California who had gotten mRNA vaccines developed myocarditis at a much lower rate: 5.8 cases for every 1 million second doses given, researchers reported, also in October, in JAMA Internal Medicine.

What all the studies have in common is that young males in their teens and 20s are at highest risk of developing the side effect, and that risk is highest after the second vaccine dose. But it’s still fairly rare, topping out at about 15 cases for every 100,000 vaccinated males ages 16 to 19, according to the larger of the two Israeli studies. Males in that age group are also at the highest risk of getting myocarditis and pericarditis from any cause, including from COVID-19.

Components of the mRNA vaccines may also cause allergic reactions, including potentially life-threatening anaphylaxis. The U.S. Centers for Disease Control and Prevention calculated that anaphylaxis happens at a rate of about 0.025 to 0.047 cases for every 10,000 vaccine doses given.

But a study of almost 65,000 health care system employees in Massachusetts suggests the rate may be as high as 2.47 per 10,000 vaccinations, researchers reported in March in JAMA. Still, that rate is low, and people with previous histories of anaphylaxis have gotten the shots without problem. Even people who developed anaphylaxis after a first shot were able to get fully vaccinated if the second dose was broken down into smaller doses.

The only side effect of the COVID-19 vaccines not seen with other vaccines is a rare combination of blood clots accompanied by low numbers of blood-clotting platelets. Called thrombosis with thrombocytopenia syndrome, or TTS, it’s most common among women younger than 50 who got the Johnson & Johnson vaccine or a similar vaccine made by AstraZeneca that’s used around the world.

About 5 to 6 TTS cases were reported for every 1 million doses of the J&J vaccine, the company reported to the U.S. Food and Drug Administration. The clots may result from antibodies triggering a person’s platelets to form clots. Such antibodies also cause blood clots in COVID-19 patients, and the risk of developing strokes or clots from the disease is much higher than with the vaccine. In one study, 42.8 of every 1 million COVID-19 patients developed one type of blood clot in the brain, and 392.3 per 1 million developed a type of abdominal blood clot, researchers reported in EClinicalMedicine in September.

Getting everyone vaccinated is not easy

The quest to vaccinate as many people as quickly as possible last year faced two main challenges: getting the vaccine to people and convincing them to take it. Strategies employed so far — incentives, mandates and making shots accessible — have had varying levels of success.

“It’s an incredibly ambitious goal to try to get the large majority of the country and the globe vaccinated in a very short time period with a brand-new vaccine,” says psychologist Gretchen Chapman of Carnegie Mellon University in Pittsburgh, who researches vaccine acceptance. Usually “it takes a number of years before you get that kind of coverage.”

Globally, that’s sure to be the case due to a lack of access to vaccines, particularly in middle- and lower-income countries. The World Health Organization set a goal to have 40 percent of people in all countries vaccinated by year’s end. But dozens of countries, mostly in Africa and parts of Asia, are likely to fall far short of that goal.

In contrast, the United States and other wealthy countries got their hands on more than enough doses. Here, the push to vaccinate started out with a scramble to reserve scarce appointments for a free shot at limited vaccination sites. But by late spring, eligible people could pop into their pharmacy or grocery store. Some workplaces offered vaccines on-site. For underserved communities that may have a harder time accessing such vaccines, more targeted approaches where shots are delivered by trusted sources at community events proved they could boost vaccination numbers.

Simply making the shot easy to get has driven much of the progress made so far, Chapman says. But getting people who are less enthusiastic has proved more challenging. Many governments and companies have tried to prod people, initially with incentives, later with mandates.

Free doughnuts, direct cash payments and entry into million-dollar lottery jackpots were among the many perks rolled out. Before the pandemic, such incentives had been shown to prompt some people to get vaccines, says Harsha Thirumurthy, a behavioral economist at the University of Pennsylvania. This time, those incentives made little difference nationwide, Thirumurthy and his colleagues reported in September in a preliminary study posted to SSRN, a social sciences preprint website. “It’s possible they moved the needle 1 or 2 percentage points, but we’ve ruled out that they had a large effect,” he says. Some studies of incentives offered by individual states have found a marginal benefit.

“People who are worried about side effects or safety are going to be more difficult to reach,” says Melanie Kornides, an epidemiologist at the University of Pennsylvania. And with vaccination status tangled up in personal identity, “you’re just not going to influence lots of people with a mass communication campaign right now; it’s really about individual conversations,” she says, preferably with someone trusted.

As COVID-19 mandates went into effect in the fall, news headlines often focused on protests and refusals. Yet early anecdotal evidence suggests some mandates have helped. For instance, after New York City public schools announced a vaccine requirement in late August for its roughly 150,000 employees, nearly 96 percent had received at least one shot by early November. Still, about 8,000 employees opted not to get vaccinated and were placed on unpaid leave, the New York Times reported.

Many people remain vehemently opposed to the vaccines, in part because of rampant misinformation that can spread quickly online. Whether more mandates, from the government or private companies, and targeted outreach will convince them remains to be seen. — Jonathan Lambert

Vaccines can’t single-handedly end the pandemic

One year in, it’s clear that vaccination is one of the best tools we have to control COVID-19. But it’s also clear vaccines alone can’t end the pandemic.

While the jabs do a pretty good job preventing infections, that protection wanes over time. Still, the vaccines have “worked spectacularly well” at protecting most people from severe disease. As more people around the world get vaccinated, fewer people die, even if they do fall ill with COVID-19.

“We have to make a distinction between the superficial infections you can get — [like a] runny nose — versus the lower respiratory tract stuff that can kill you,” such as inflammation in the lungs that causes low oxygen levels, Luning Prak says. Preventing severe disease is the fundamental target that most vaccines, including the flu shot, hit, she notes. Stopping infection entirely “was never a realistic goal.”

Because vaccines aren’t an impenetrable barrier against the virus, we’ll still need to rely on other tactics to help control spread amid the pandemic. “Vaccines are not the sole tool in our toolbox,” says Saad Omer, an epidemiologist at Yale University. “They should be used with other things,” such as masks to help block exposure and COVID-19 tests to help people know when they should stay home.

For now, it’s crucial to have such layered protection, Omer says. “But in the long run, I think vaccines provide a way to get back to at least a new normal.” With vaccines, people can gather at school, concerts or weddings with less fear of a large outbreak.

Eventually the pandemic will end, though when is still anyone’s guess. But the end certainly won’t mean that COVID-19 has disappeared.

Many experts agree that the coronavirus will most likely remain with us for the foreseeable future, sparking outbreaks in places where there are pockets of susceptible people. Susceptibility can come in many forms: Young children who have never encountered the virus before and can’t yet get vaccinated, people who choose not to get the vaccine and people whose immunity has waned after an infection or vaccination. Or the virus may evolve in ways that help it evade the immune system.

The pandemic’s end may still feel out of reach, with the high hopes from the beginning of 2021 a distant memory. Still, hints of normalcy have returned: Kids are back in school, restaurants and stores are open and people are traveling more.

References and Citations

Johnson & Johnson. Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S. Press release, September 21, 2021.

W.H. Self et al. Comparative effectiveness of Moderna, Pfizer-BioNTech, and Janssen (Johnson & Johnson) vaccines in preventing COVID-19 hospitalizations among adults without immunocompromising conditions — United States, March – August 2021. Morbidity and Mortality Weekly Report. Vol. 70, September 24, 2021, p. 1337. doi: 10.15585/mmwr.mm7038e1.

Witberg, et al. Myocarditis after COVID-19 vaccination in a large health care organization.New England Journal of Medicine. Published online October 6, 2021. doi: 10.1056/NEJMoa2110737.

Mevorach, et al. Myocarditis after BNT162b2 mRNA vaccine against COVID-19 in Israel.New England Journal of Medicine. Published online October 6, 2021. doi: 10.1056/NEJMoa2109730.

Simone, et al. Acute myocarditis following COVID-19 mRNA vaccination in adults aged 18 years or older. JAMA Internal Medicine. Published online October 4, 2021. doi:10.1001/jamainternmed.2021.5511.

G. Blumenthal, et al. Acute allergic reactions to mRNA COVID-19 vaccines. JAMA. Vol. 325, March 8, 2021, p. 1562. doi:10.1001/jama.2021.3976.

Janssen Biotech, Inc. Briefing material. U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee meeting. October 15, 2021.

Taquet et al. Cerebral venous thrombosis and portal vein thrombosis: A retrospective cohort study of 537,913 COVID-19 cases. EClinicalMedicine. July 31, 2021. doi: 10.1016/j.eclinm.2021.101061.

Thirumurthy et al. Association between statewide financial incentive programs and COVID-19 vaccination rates. Posted September 3, 2021. doi: 10.2139/ssrn.3912786.

  1. Lytras et al. Interventions to increase seasonal influenza vaccine coverage in healthcare workers: A systematic review and meta-regression analysis. Human Vaccines and Immunotherapeutics. Vol 12, May 5, 2016 p. 671. doi: 10.1080/21645515.2015.1106656.
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