Search Results - EDQM

European Directorate for the Quality of Medicines & HealthCare

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the ''Convention on the Elaboration of a European Pharmacopoeia'' (an international treaty adopted by the in 1964: ETS 50, Protocol).

The signatories to the convention, – 39 member states and the European Union (EU) as of March 2020 – are committed to the harmonisation of quality standards for safe medicines throughout the European continent and beyond. In addition to the member states there are currently 30 observers, including the World Health Organization (WHO) and the Taiwan Food and Drug Administration (TFDA). The EDQM's quality standards for medicines are published in the European Pharmacopoeia (officially abbreviated to Ph. Eur.), which is recognised as a scientific benchmark worldwide and is legally binding in member states.

The EU pharmaceutical legislation refers directly to the Ph. Eur. and to other activities for which the EDQM is responsible (e.g. the Certification procedure or "CEP" and the OMCL Network – see below), demonstrating the shared commitment of the European organisations to public health protection.

The EDQM is also involved in a number of international collaboration and harmonisation initiatives, such as the Pharmacopoeial Discussion Group (PDG), the [http://www.iprp.global/home International Pharmaceutical Regulators Programme] (IPRP), the [https://www.ich.org/ International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use] (ICH), the [https://web.archive.org/web/20141009000711/http://www.who.int/medicines/areas/quality_safety/quality_assurance/resources/qas_worldpharmmeeting/en/ International Meeting of World Pharmacopoeias] (IMWP), the [https://picscheme.org/ Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme] (PIC/S) and the International API Inspection Programme (co-ordinated by the European Medicines Agency, or EMA).

In addition, the EDQM works closely with World Health Organization (WHO) on the establishment, monitoring and distribution of WHO International Standards for Antibiotics (ISA) and WHO International Chemical Reference Substances (ICRS) which are necessary to apply the tests described in the [https://archive.today/20121212002931/http://apps.who.int/phint/en/p/about/ WHO International Pharmacopoeia].

The EDQM therefore plays an essential role in the complex regulatory framework for medicines in Europe. Its primary purpose is to protect public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use. Provided by Wikipedia