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The EDQM’s contributions to the protection of public health in the COVID-19 pandemic: latest information

Last updated on 6 May 2020

The EDQM’s core activities include the provision of documentary and physical (reference) standards to ensure the quality of medicines and their ingredients. Availability of and access for patients to quality medicines is more important than ever in the context of the current COVID-19 pandemic. This is why the EDQM is working hard to ensure the continuous supply of our goods and services and is engaging with all stakeholders, including national, European and international authorities, to help protect public health.

 

EDQM business continuity plan to safeguard core activities

The EDQM has established a business continuity plan to anticipate and mitigate risks of disruption to our activities, so that the standards necessary for the production and release of medicines by pharmaceutical manufacturers and for market surveillance testing by Official Medicines Control Laboratories (OMCLs) remain available during this pandemic.

To protect the health of staff and the public, all EDQM staff not essential to conducting experimental or physical operations on-site have been working remotely since 16 March. The tools and measures which we have implemented have proven to be efficient, enabling us to provide our services even under the current difficult circumstances.

All our operations are currently running at regular capacity and our business continuity measures are being continually monitored and adapted, as necessary.

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Pharmacopoeia and quality standards

The work of the European Pharmacopoeia Commission and its 60 groups of experts and working parties is ongoing.

Forty-two draft texts for public consultation have been published in Pharmeuropa 32.2 according to schedule, with comments to be submitted by 30 June 2020. In view of the current situation faced by users in areas affected by COVID-19, the European Pharmacopoeia strongly recommends that users who wish to provide comments on a Pharmeuropa text, but who are unable to do so before the end of the commenting period, should contact their National Pharmacopoeia Authority (NPA) in Ph. Eur. member states or the EDQM (via its HelpDesk).
More information can be found here.

The European Pharmacopoeia has also launched an extraordinary public consultation on how best to include oxygen 98 per cent obtained via two-stage concentrators in the Ph. Eur.

The preparation of European Pharmacopoeia Supplement 10.3 is well underway.

The European Pharmacopoeia Online and our public consultation platform Pharmeuropa, as well as all other databases and documentary resources, are functioning normally, are fully accessible and are continually updated.

In addition, the European Pharmacopoeia Archives are available to all users with an up-to-date subscription (print or electronic) and have been recently updated with the three volumes of the 10th Edition (10.0). In order to facilitate access to European Pharmacopoeia texts in these extraordinary circumstances, Supplements 10.1 and 10.2 can now be downloaded from our FreePub website.

The European Pharmacopoeia and the British Pharmacopoeia have worked together to make supportive pharmacopoeial texts (monographs, general chapters, appendices and supplementary chapters) 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 and withdrawn as required. More information can be found here.

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Reference Standards

The EDQM is ensuring the supply of our Reference Standards to help maintain the availability of quality medicines in Europe and beyond. Due to the outbreak, the functioning of the EDQM laboratory, manufacturing and logistics entities has been adapted and reinforced to protect the health, safety and security of staff while they continue to develop, produce and dispatch our Reference Standards.

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Certification Procedure (CEPs)

Applications for new and revised or renewed CEPs continue to be received and are assessed in accordance with the procedure. The EDQM informs applicants electronically of the outcome of the evaluation. CEPs are sent out in a secure manner and paper documents continue to be shipped by carrier. However, some delays in reception may be encountered due to transport disruptions currently affecting some carriers and certain regions.

All on-site inspections have been postponed until further notice, due to current travel restrictions around the globe.

Due to the measures implemented to protect its staff from the pandemic, the EDQM has prioritised certain activities linked with CEPs over others.

Find more information on the impact of the COVID-19 outbreak on the certification procedure

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OMCL Network: quality control of medicines, including Official Control Authority Batch Release procedure

In the interest of public health, the EDQM is closely collaborating with the OMCLs involved in the testing control of human and veterinary medicines to help ensure continuity of important activities, including the Official Control Authority Batch Release (OCABR) of vaccines and human blood- and plasma-derived medicinal products, where, as a mitigating measure, the EU OCABR network has adopted an emergency strategy, in force since 31 March 2020, to assure the continued release of these essential medicines.

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Support to pharmacists on products and paediatric formulations

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. In the news "Products and extemporaneous preparation of paediatric formulations that may be useful in the treatment of COVID-19", published on 27 March 2020, stakeholders were asked to support this initiative and to submit information on formulations and products. The tables (currently for Chloroquine, Hydroxychloroquine and Lopinvir/Ritonavir) will be continually updated.

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Illegal and falsified medicines 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.

 

Advice to the public

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 would like to remind the public that there are currently no authorised medicines to prevent or treat 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.

The European Centre for Disease Prevention and Control has published advice in a report entitled “Infection prevention and control in the household management of people with suspected or confirmed coronavirus disease (COVID-19)

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Supporting member states to ensure access to safe blood transfusion and organ, tissue and cell transplantation

In the field of Substances of Human Origin (SoHO), and through its European Committee on Blood Transfusion (CD-P-TS), European Committee on Organ Transplantation (CD-P-TO) and subordinate working groups, the EDQM 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 on the SoHO sector.

In this line, a webinar entitled “Tissue donation from deceased donors during the COVID-19 pandemic” was organised on Tuesday, 28 April 2020. The webinar featured leading experts in the field discussing how the pandemic is affecting national programmes for tissue donation from deceased donors and daily practices in tissue establishments, and provide a forum to support forward-looking decisions. More information about this webinar may be found here

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