The European Pharmacopoeia (Ph. Eur.) Commission made major progress in the field of biotherapeutic products and animal protection in the course of 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 Health Surveillance Agency of Brazil and the Chinese Pharmacopoeia Commission.
On the healthcare side, the EDQM brought forward its work on ensuring the safety and quality of blood transfusions in Europe. It did so by providing continuous support to European Blood Establishments (BEs) in the implementation of some key aspects of ensuring the optimal use of blood and the protection of both donors and recipients, such as Quality Management (QM) elements, risk management, change control and validation/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.
2016 saw the launch 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 non-European Pharmacopeia member states and non-observer states. 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 5-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 Council of Europe’s Committee of Ministers. The European Union Commission adopted as a legal instrument in the EU the Council of Europe’s Good Practice Guidelines for blood establishments 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 brochures for the public, Umbilical Cord Blood Banking. A Guide for the Parents (2nd edition) and Exercise your way to better post-transplant health.
The Ph. Eur. Commission adopted its first finished product monograph containing a chemically defined active substance and adopted its strategy for the implementation of the ICH Q3D Guideline on Elemental impurities. The Republic of Korea was granted observer status to the European Pharmacopoeia Convention and following the 5th ratification by the Republic of Guinea, the Medicrime Convention will enter into force on 01 January 2016. New editions of the Guide to the Preparation, Use and Quality Assurance of Blood Components (18th Edition), the Guide to the Quality and Safety of Tissues and Cells for Human Application (2nd Edition) and the Technical Guide for the Elaboration of Monographs (7th Edition) were released. Resolutions on haemophilia therapies and immunoglobulin therapies for immunodeficiency and other diseases were also adopted. The EDQM signed an agreement with the European Medicines Verification Organisation (EMVO) on the performance of periodic conformity assessments of the European Medicines Verification System ("EMVS") and its governance.
The year 2014 was an anniversary year for the EDQM. It celebrated the 50th Anniversary of the Convention on the Elaboration of a European Pharmacopoeia (Ph. Eur.), and the 20th anniversary of the OMCL Network and of the procedure for Certification of Suitability to the European Pharmacopoeia Monographs. The Ph. Eur. Commission published its first monograph on a chemically-defined finished product as a draft for public inquiry in Pharmeuropa and approved, together with the Committee of Experts CD-P-PH, a project for the elaboration of a pan-European formulary for non-licensed medicines for children. Azerbaijan was granted observer status to the European Pharmacopoeia Convention and Hungary and Moldova both ratified the Medicrime Convention. Recommendations defining minimum standards for haemophilia care in Europe were published and a new Standards Terms database was launched.
The EDQM Laboratory was accredited as ISO/IEC 17025:2005 compliant and the ISO 9001:2008 certification was extended to cover the conduct of laboratory studies. The 8th Edition of the PhEur came into force and South Africa and the Taiwan Food and Drug Administration (TFDA) were granted observer status to the European Pharmacopoeia Convention. Spain ratified the Medicrime Convention and the OCABR Network was enlarged to welcome Canada and Israel.
The 1st Edition of the Guide to the quality and safety of tissues and cells for human application was produced and several new publications on combatting counterfeit medicines and similar crimes.
The eTACT project, the EDQMs’ anti-counterfeiting traceability service for medicines was launched. Ukraine became the first country to ratify the Medicrime Convention and the 38th Member of the European Pharmacopoeia Convention and the Republic of Guinea and Singapore received observer status. The ISO 9001:2008 certificate was extended to cover the management of the elaboration, revision, correction and suppression of European Pharmacopoeia texts, their publication in printed and electronic format, as well as their distribution.
On 24 June 2011, the EDQM signed a trilateral Memorandum of Understanding (MoU) with the State Administration of Traditional Chinese Medicine of the People's Republic of China (SATCM) and its National Key Institute of TCM Quality Control (NKI-TCM).
The ISO 9001:2008 certificate was extended to the market surveillance of finished medicinal products and issuance of guidelines for the release of human immunological and blood derivative medicinal products.
Memorandums of Understanding are signed with the National Institute of Food and Drug Safety Evaluation (NIFDS), Korea Food and Drug Administration, and the Chinese National Institute of Food and Drug Control (NIFDC), respectively.
The EDQM takes over responsibility for the establishment, preparation, storage and distribution of WHO International Chemical Reference Substances (ICRS).