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EDQM initiatives in the context of COVID-19 vaccines and therapies

Last updated on 20 November 2020

The EDQM is committed to supporting competent authorities, manufacturers and developers of medicines, including vaccines, and health professionals during the COVID-19 pandemic – as well as contributing to the wider global effort to combat the virus – by openly sharing knowledge and offering free access to relevant standards and guidance.

Details of EDQM initiatives concerning COVID-19 vaccines and therapies can be found below.

 

Vaccine guidance, quality standards, OCABR guidelines and training

As efforts to develop vaccines for COVID-19 continue, the EDQM is providing support in the form of guidance documents, quality standards and training materials, among others.

  • New EDQM document on recombinant viral vectored vaccines to support COVID-19 vaccine developers

The EDQM has drafted a text on the control of viral vectored vaccines in order to support COVID-19 vaccine developers currently working on candidate vaccines based on this technology. This work was accomplished in collaboration with the European Pharmacopoeia Group of Experts on vaccines for human use (Group 15).

More information available here.


  • COVID-19 vaccines: release of guidelines critical for co-ordinated independent batch control by EU OMCLs

The EDQM has published three new Official Control Authority Batch Release (OCABR) guidelines outlining the tests to be performed by Official Medicines Control Laboratories (OMCLs) in the EU OCABR Network as part of the independent control of pandemic COVID-19 vaccine batches.

More information available here.


  • EDQM releases updated European Pharmacopoeia vaccines package

Following the publication of the text on recombinant viral vectored vaccines (details here), the EDQM has published an updated set of guidance and pharmacopoeial quality standards applicable to candidate COVID-19 vaccines. This is to ensure that all the relevant Ph. Eur. documents are freely available to users.

Pharmacopoeial texts for vaccine developers.


  • EDQM continues to support COVID-19 vaccine developers by providing selected training materials

Further to the publication of the COVID-19 vaccine developers’ package of pharmacopoeial texts, the EDQM has compiled a companion list of training materials on the European Pharmacopoeia and on Ph. Eur. texts related to vaccines to support users in applying those texts.

Additional information here.

Ph. Eur. vaccine training resources.


  • COVID-19 vaccines and therapies: EMA and European Pharmacopoeia texts

In the current rush to develop and market COVID-19 vaccines and therapies, it is essential to help developers identify relevant and applicable guidelines and standards rapidly. This is why the European Medicines Agency (EMA) and the European Pharmacopoeia are facilitating access to COVID-19 vaccines and therapies guidelines, resources and pharmacopoeial texts for developers on their websites.

EMA's guidance for medicine developers

Pharmacopoeial texts for vaccine developers.

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Antiviral medicines: supportive pharmacopoeial texts available for free

  • COVID-19 update: Ph. Eur. and British Pharmacopoeia working together to offer free access to supportive pharmacopoeial texts

The European Pharmacopoeia and the British Pharmacopoeia have worked together to make supportive pharmacopoeial texts (monographs, general chapters, appendices and supplementary chapters) relevant for antiviral medicines available for a limited period of time at no cost to users. The texts – available as downloadable PDFs – include monographs, general chapters, appendices and supplementary chapters to support those developing, manufacturing or testing relevant substances and products during this challenging period. They will be kept under review and updated or withdrawn as required.

More information available here.

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CEP fast-track procedure: active substances of interest for COVID-19 therapies

The EDQM has established a fast-track procedure to respond to users’ needs as quickly as possible. This procedure is applied upon request from CEP holders or authorities and on a case-by-case basis for those substances specifically related to COVID-19. This procedure has made it possible to assess applications and grant CEPs more rapidly.

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Paediatric formulations that may be used for COVID-19 therapies: sharing knowledge to help health professionals

The European Pharmacopoeia Commission’s European Paediatric Formulary (PaedF) Working Party is compiling existing knowledge on paediatric formulations and marketed products that may be useful in the treatment of COVID-19.

  • Products and extemporaneous preparations of paediatric formulations that may be used in the treatment of COVID-19

In March 2020, stakeholders were asked to support this initiative and to submit information on formulations and products. The tables (currently for dexamethasone and lopinavir/ritonavir) will be continually updated. Updating of tables for chloroquine and hydroxychloroquine has been discontinued.

More information available here.

See also:

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Illegal and falsified medical products and illegal online pharmacies

The coronavirus outbreak has regrettably offered new opportunities for criminals to take advantage of the increased demand for medical, personal-protection and hygiene products, including by advertising and offering for sale unauthorised medicines, claiming to prevent or treat COVID-19, as well as falsified medicines and test kits.

  • Impact of COVID-19 crisis – National authorities in Europe report shortages of medical products and increase in illegal activities

An exchange of experience and information related to the COVID-19 pandemic took place at the spring meeting of the Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical Products and Similar Crimes (CD-P-PH/CMED). Delegates’ reports confirmed that criminals never miss an opportunity to exploit a crisis, and most countries had to counter efforts to turn a profit from shortages of medicines and medical devices. Many found arrangements to resolve such problems through regional co-operation or export regulations.

More information available here.


  • MEDICRIME Convention

At a time of unprecedented challenges to the health sector, the Council of Europe calls on governments to be extremely vigilant against falsified medical products. States can rely on the MEDICRIME Convention to safeguard public health and target criminals trying to take advantage of the current crisis by offering falsified medical products for sale.

More information on the Council of Europe MEDICRIME Convention available here.


  • WHO alerts

The World Health Organization (WHO) releases alerts on falsified medical products. Due diligence is required from all actors in the procurement, use and administration of medical products, in particular those affected by the COVID-19 pandemic.

More information on WHO medical product alerts available here.

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Advice to the public on illegal and falsified medical products

European citizens are advised to exercise extra caution when buying medicines online, as illegal online pharmacies and other vendors may try to benefit from the pandemic situation to sell unauthorised, falsified or low-quality medicines.

The EDQM reminds the public that there are currently no authorised medicines to prevent COVID-19 and that they should not buy medicines advertised as such online. Medicines are available to treat the symptoms on advice from their doctor or pharmacist.

  • EMA initiatives

Different member states have reported illegal internet sales of medicines that claim to prevent or treat COVID-19. The European Medicines Agency (EMA) has posted a public communication on this topic on their website, warning against falsified medicines from unregistered websites.


  • Europol

Europol confirmed in an operation in early 2020 that criminal activity involving attempts to sell unauthorised medicines was increasing: “Rise of fake ‘corona cures’ revealed in global counterfeit medicine operation”.

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Blood transfusion and organ, tissue and cell transplantation: minimising the impact of the COVID-19 pandemic

In the field of substances of human origin (SoHO), the EDQM, through its European Committee on Blood Transfusion (CD-P-TS), European Committee on Organ Transplantation (CD-P-TO) and subordinate working groups, is facilitating the exchange of information and fostering co-operation between member states and health authorities to minimise the impact of the COVID-19 pandemic.

The EDQM, in collaboration with the European Commission, recently organised a virtual conference, entitled “Keeping up with Reality and Quality: A Challenge for European Blood Establishments”, to mark 10 years of successful collaboration in the field of blood. One of the webinar sessions focused on the COVID-19 pandemic and featured key stakeholders from the sector discussing how they have managed the crisis in order to ensure the continuity of blood supply and elaborating on lessons learnt.

The recording of the webinar is available here.

Two webinars, entitled “Tissue donation from deceased donors during the COVID-19 pandemic” (April 2020) and “Keep calm and use your QMS to carry on: Tissue banking in the new normality” (July 2020) were also organised. They featured leading experts in the field discussing how the pandemic has affected national programmes for tissue donation from deceased donors and daily practices in tissue establishments, and provided a forum to support forward-looking decisions.

More information on transplantation events training resources available here.

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