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 its goods and services and is engaging with all stakeholders, including national, European and international authorities, to support public health protection.
- Business continuity plan to safeguard core activities
- Additional supporting activities to protect public health
- Access to safe blood transfusion and organ, tissue and cell transplantation
The EDQM has established a business continuity plan to anticipate and mitigate risks of disruption to its 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 worked remotely during the lock-down in France. The tools and measures implemented proved to be efficient, enabling the EDQM to provide its services even under difficult circumstances. While the majority of staff have been back on site since 8 June, the EDQM closely monitors the current situation and adapts its working methods to comply with strict hygiene regulations and continued restrictions such as physical distancing.
All EDQM operations are running at regular capacity and business continuity measures are being continually monitored and adapted, as necessary.
The work of the European Pharmacopoeia Commission and its 60 groups of experts and working parties continues regularly.
Forty-eight draft texts for public consultation have been published in Pharmeuropa 32.3, comments can be submitted until 30 September 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).
For more information: Pharmeuropa 32.3 just released
The European Pharmacopoeia Supplement 10.3 is now available.
The European Pharmacopoeia Online and its 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, which are available to all users with an up-to-date subscription (print or electronic), have been recently updated with the three volumes of the 10th Edition (10.0).
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 reference standards.
Applications for new and revised or renewed certificates of suitability (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 still be encountered due to transport disruptions currently affecting some carriers and certain regions.
Lockdowns throughout Europe and the world have affected the processing times for the evaluation of CEP dossiers. The actual timelines are reported regularly in the CEP monthly reports published on the EDQM website.
The EDQM is aware that companies may have issues regarding submissions of information linked to CEP dossiers under assessment (e.g. preparing and sending responses to deficiency letters), inspections (e.g. preparing and sending CAPA) and risk assessments related to nitrosamines. The EDQM expects to be informed as soon as possible by CEP holders/substance manufacturers in case they cannot meet deadlines for submitting the information requested.
All on-site inspections have been postponed until further notice, due to current travel restrictions around the globe. The EDQM is monitoring GMP compliance of sites through exchange of information with international partners and distant assessments.
The EDQM has prioritised certain activities linked with CEPs over others. For example, cancellations of CEPs upon request from the holders have been put on hold and will be implemented at a later stage to enable faster handling of requests that are of importance in the COVID-19 setting.
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.
In order to organise the transfer of the potential future batch release tests for COVID-19 vaccine candidates to OMCLs earlier than in the usual process, the EU OCABR Advisory Group has prepared a recommendation document on method transfer for OMCLs and manufacturers. The OCABR network members have also prepared a list of OMCLs with capabilities relevant to the future release of COVID-19 candidate vaccines to help manufacturers identify potential partners for the OCABR of their candidate vaccines. Interested manufacturers can request a copy of either document via firstname.lastname@example.org.
The EDQM is committed to supporting competent authorities 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 temporary free access to relevant standards and guidance and standards.
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.
For more information, COVID-19 update: Ph. Eur. and British Pharmacopoeia working together to offer free access to supportive pharmacopoeial texts
To support organisations involved in the development, manufacture or testing of candidate COVID-19 vaccines worldwide, many of which are universities and small and medium-sized enterprises, the EDQM is offering temporary free access to texts of the European Pharmacopoeia in the field of vaccines. The texts are available on the EDQM FreePub website until further notice. The list of texts is not exhaustive and will be reviewed regularly and updated as required. It will be withdrawn when appropriate.
A document compiling selected EDQM training materials on the Ph. Eur. and on Ph. Eur. texts related to vaccines has been published as a companion to this package of pharmacopoeial texts. The aim is to fast-track candidate COVID-19 vaccine developers’ understanding of the Ph. Eur. and show how to apply the relevant texts.
For more information, see the following news items: “EDQM provides COVID-19 vaccine developers with free access to quality standards applicable in Europe” and “EDQM continues to support COVID-19 vaccine developers by providing selected training materials”.
Ph. Eur. Supplements 10.1 and 10.2 are freely available and can be downloaded from the FreePub website.
The EDQM has established a fast-track procedure to respond to stakeholder requests as quickly as possible. This new procedure is applied upon request and on a case-by-case basis for those substances of specific interest in the COVID-19 setting. This procedure has made it possible to assess and grant new CEPs and revise existing ones more rapidly than defined by the normal timelines.
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.
- Products and extemporaneous preparations of paediatric formulations that may be used in the treatment of COVID-19
- European Paediatric Formulary
- More information on the European Paediatric Formulary
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 the COVID-19 crisis – 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.
Read more in the news bulletin “Impact of COVID-19 crisis – National authorities in Europe report shortages of medical products and increase in illegal activities” (9 June 2020).
- 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 who are taking advantage of the current crisis by proposing falsified medical products for sale.
- The World Health Organization (WHO) has released medical product alerts on falsified medical products, including in vitro diagnostics, that claim to prevent, detect, treat or cure COVID-19 (N° 03/2020), on falsified chloroquine products circulating in the WHO region of Africa (N°4/2020), and on Falsified and contaminated Defibrotide identified in WHO regions of Western Pacific, Europe and Eastern Mediterranean (N°5/2020). Due diligence is required from all actors in the procurement, use and administration of medical products, in particular those affected by the current crisis of, or related to, COVID-19 (more about all WHO medical product alerts).
- Different member states have reported illegal internet sales of medicines that claim to prevent or treat COVID-19. The European Medicines Agency (EMA) has published a public communication on this topic on their website, warning against falsified medicines from unregistered websites.
- Europol confirmed in a recent operation that there is increased criminal activity involving attempts to sell unauthorised medicines.
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)”.
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” 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. For more information, see “EDQM webinar: tissue donation from deceased donors during the COVID-19 pandemic”.