Back 2016

The year 2016 saw the publication of the 9th edition of the European Pharmacopeia and the election of a new Chair and two new Vice-Chairs to the Ph. Eur. Commission.

The Ph. Eur. Commission also revised its working procedures to open up to nominations for its Groups of Experts and Working Parties to experts from states that are neither members of nor observers to the European Pharmacopeia.

India and Japan were both granted observer status and the Ph. Eur. Commission concluded its P4Bio pilot phase which resulted in the successful publication of five drug substance monographs.

The EDQM and Japanese Pharmaceutical Safety and Environmental Health Bureau of the Ministry of Health, Labour and Welfare (MHLW) signed a five-year Memorandum of Cooperation and agreed terms for sharing information related to active pharmaceutical ingredients of interest to both Europe and Japan. The EDQM also became an observer to the International Council for Harmonisation (ICH).

Two new resolutions on good reconstitution practices in health care establishments and the quality and safety of medicines prepared in pharmacies for the special needs of patients were adopted by the Committee of Ministers of the Council of Europe.  The European Commission adopted the Council of Europe’s Good Practice Guidelines for blood establishments as a legal instrument in the EU, via its Directive (EU) 2016/1214.  Albania, Armenia, Belgium and France ratified the MEDICRIME Convention.

The EDQM revised its roadmap for electronic submissions of Certificates of Suitability (CEP) applications and issued guidance on the implementation of ICH Q3D on elemental impurities in the CEP Procedure.

Other publications released included the 6th edition of the “Guide to the quality and safety for organs for transplantation” and two booklets for the general public, “Umbilical Cord Blood Banking. A Guide for the Parents” (2nd edition) and “Exercise your way to better post-transplant health”. 

Full details are available in the EDQM 2016 Annual Report.