The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published its 2013 annual report detailing the agency’s activities for the past year. The report gives an overview of the organization’s history, goals, activities, and accomplishments.
According to EDQM Director Susanne Keitel, EDQM adopted 30 new monographs and revised approximately 200 texts, including implementation of quality by design. The agency’s agenda of developing biopharmaceutical and advanced therapy standards and recommendations saw the creation of two new working parties that would give recommendations on raw materials for the production of cell and gene-therapy products and test methods for the detection and quantification of host cell-derived proteins.
EDQM has also continued its efforts to harmonize pharmacopeial standards worldwide by participating in the Pharmacopoeial Discussion Group (PDG) and the World Health Organization’s (WHO) monograph development harmonization initiative. The agency also extended the portfolio of reference standards to match developments related to new and revised monographs. According to the report, the number of new applications for the certification of suitability to the monographs of the Ph. Eur. procedure decreased from 2012; however, the number of revision requests increased.
EDQM’s anticounterfeiting efforts included the “promotion of the MEDICRIME convention and the ‘single points of contact’ network beyond Europe, the further development of eTACT, the EDQM’s anticounterfeiting traceability service for medicines and the API Fingerprint Programme, developed in close collaboration with the Official Medicines Control Laboratories (OMCL) network.” The OMCL set up new programs for testing falsified and other illegal medicines, the testing of unlicensed pharmaceutical preparations, and quality control of APIs.
Additional milestones can be found in the report, which is available for download from the EDQM website.