The European Directorate for the Quality of Medicines & HealthCare’s 2019 annual report is now available, providing a comprehensive overview of our activities in 2019 and information on our achievements and events.
We support health systems at national level and help protect patients by enabling reliable testing of medicines via the legally binding standards of the European Pharmacopoeia (Ph. Eur.) and co-ordinating post-market surveillance programmes that ensure the quality of medicines on the market. Our work and guidance on pharmaceutical care, transplantation, transfusion, cosmetics and food contact materials and articles ensure that the best scientific knowledge available in these fields is disseminated throughout Europe and made available to all professionals concerned.
Our success in these areas would not have been possible without the remarkable efforts of our experts who, through their expertise in a wide variety of scientific fields, have made valuable contributions to our work.
The highlights of 2019, another very productive and successful year for the EDQM, include:
- the Ph. Eur. Commission continued to provide Ph. Eur. users with up-to-date and science-based quality standards by adopting 257 new or revised Ph. Eur. texts;
- the Ph. Eur. portfolio of reference standards continued to grow;
- a secondary site to house the EDQM’s contingency stocks of reference standards was inaugurated as part of our business continuity strategy;
- the procedure for the certification of suitability to the Ph. Eur. monographs (CEPs) again demonstrated its added value for regulatory authorities: with 254 new certificates issued, the number of valid CEPs is now over 5 200;
- work-sharing within the network of European Official Medicines Control Laboratories (OMCLs) allowed members to cover a broad range of products on the market and address emerging risks to public health;
- milestones were reached in pharmaceutical care, such as the adoption of a resolution on the promotion and implementation of pharmaceutical care in Europe by the Council of Europe Committee of Ministers;
- the first two monographs and two general texts of the European Paediatric Formulary were adopted and now provide healthcare professionals with useful guidance;
- trusted and ethical safety and quality standards for the collection, preparation, storage, distribution and appropriate use of blood components for blood transfusion and for the transplantation of organs, tissues and cells continued to be proposed, and the publication of the 4th edition of the Guide to the quality and safety of tissues and cells for human application was welcomed by health professionals;
- work related to the co-ordination of market surveillance studies and proficiency testing schemes in the area of quality control for cosmetics continued, along with efforts to update existing and develop new standards in the field of food contact materials;
- and, last but not least, the EDQM continued its action and efforts to address the presence of N-nitrosamines in active substances and medicines and supported regulatory authorities at national, international and EU level in this field. Regular updates were published on our website.
Find out much more by reading the “EDQM Highlights – 2019 annual report”.