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.