EDQM Releases Annual Report

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The directorate highlights its 2016 achievements.

The European Directorate for the Quality of Medicines & Healthcare (EDQM) published its 2016 Annual Report on June 27, 2017. The report details the accomplishments the directorate achieved in 2016. The report emphasizes the publication of the 9th edition of the European Pharmacopoeia (Ph. Eur.) and the efforts made in global harmonization of standards and regulations throughout and beyond the European Union.

The 9th edition of Ph. Eur., published in 2016, contains more than 50% revised or new texts, including newly developed methods and techniques. It contains 2343 monographs, 359 general texts, and approximately 2650 descriptions of reagents. Twenty-six new monographs were added. Notable additions include the monograph for Etanercept, which showed how specifications are compatible with the development of high-quality biotherapeutic products. Chapters on chemical imaging and in-vitro methods for the quality control of vaccines were also introduced.

The Ph. Eur. Commission’s implementation of the International Council for Harmonization’s Q3D elemental impurities guideline was fine-tuned. Revised versions of its general monographs on substances for pharmaceutical use (2034), pharmaceutical preparations (2619), and revised general chapters on elemental impurities (5.20 and 2.4.20) were adopted.

EDQM increased its expert input, international outreach, and harmonization efforts in 2016. The Ph. Eur. Commission appointed 700 experts in 2016 and added India and Japan to its observer states, bringing the total to 30. The directorate participated in international platforms in 2016 including signing confidentiality agreements with new countries and joint inspections. Twenty-nine projects in the Biological Standardization Program were run, with four concluding in 2016.


“Throughout 2016, the EDQM continued to deliver against its mission of promoting and protecting human and animal health. The diversity and abundance of results mentioned in this report show the relevance of our work in ensuring the basic right of access to good quality medicines and healthcare,” stated EDQM Director Susanne Keitel.