null 2017

The European Pharmacopoeia Commission made major progress in the field of biotherapeutic products and animal protection in 2017.

In particular, the first monograph on a monoclonal antibody (mAb): Infliximab concentrated solution (2928) was adopted, marking an important milestone in relation to biotherapeutic products.  

Following the decision to suppress completely the test for abnormal toxicity from the Ph. Eur., 49 monographs were revised, including 36 monographs on vaccines for human use. The Republic of Moldova became a member of the Ph. Eur. Commission in April, bringing the number of signatories to the Convention on the Elaboration of a European Pharmacopoeia to 39 (38 member states and the European Union). In terms of international relations, memorandums of understanding were signed with ANVISA (the Brazilian Health Regulatory Agency) and the Chinese Pharmacopoeia Commission.

On the healthcare side, the EDQM made progress in securing the safety and quality of blood transfusions in Europe by providing continuous support to European blood establishments (BEs) in the implementation of key aspects of ensuring the optimal use of blood and the protection of both donors and recipients, such as quality management, risk management, change control, and validation and qualification. The EDQM also published the 3rd Edition of its Guidelines on the quality and safety of tissues and cells for human application. In the field of cosmetics, a new guide on safer tattooing provided an overview of current knowledge and challenges in the toxicological assessment of inks for tattoos and permanent make-up.

Full details are available in the EDQM 2017 annual report
 

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