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EDQM Annual Report 2010

EDQM Brochure: Serving public health in Europe since 1964 (Updated April 2012)

2011

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.

2010

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).

2009
The EDQM's assessment and inspection activities within the Procedure for the Certification of Suitability of the Monographs of the European Pharmacopoeia are awarded ISO 9001:2008 certification by the official French standardisation body (Association française de normalisation - Afnor) via Afnor Certification (AFAQ);
The EDQM becomes responsible for developing harmonised approaches to ensure product quality and safety in the areas of:

cosmetic products; and
packaging materials for food and pharmaceutical products;

Memorandums of Understanding (MoUs) on the exchange of information relating to the manufacturing of active pharmaceutical ingredients (APIs) and excipients used in medicinal products are signed with:

the United States Food and Drug Administration (FDA); and
the Australian Therapeutic Goods Administration (TGA).

2008

The EDQM becomes responsible for co-ordinating activities linking the quality of medicines to the quality and safety of their use in the following fields: the classification of medicines as regards their supply, pharmaceutical practices and care and risk prevention and management of counterfeiting of medical products and similar crimes.

2007

Memorandums of Understanding are signed with:

the Pharmaceutical Inspection Cooperation Scheme (PIC/S) to facilitate the exchange of information and collaboration on inspections of manufacturing sites for active pharmaceutical ingredient (APIs) and blood transfusion services;

the Heads of Medicines Agency to facilitate the development of a post marketing surveillance scheme for medicines authorised by the mutual recognition or decentralised procedure;

the Chinese authorities, represented by the Shanghai Food and Drug Administration (ShFDA) and Shanghai Institute Food and Drug Control (SIFDC), to facilitate the accessibility of European Pharmacopoeia Reference Standards to Chinese medicine manufacturers;

the Shanghai Municipal Food and Drug Administration to facilitate collaboration on analytical studies;
the Health Products and Food Branch (HPFB) of Health Canada allowing the filing of Certificates of Suitability of the Monographs of the European Pharmacopoeia with its Therapeutic Products Directorate, thus avoiding duplicate evaluations;
the National Institute for the Control of Pharmaceutical Biological Products (NICPBP) to collaborate on the publishing of a technical guide in Chinese.

The new EDQM headquarters is inaugurated.

2006

The EDQM becomes responsible for blood transfusion and organ transplantation activities; the EDQM takes over responsibility for WHO International Standards for Antibiotics (ISA).

2004

Directives 2001/83/EC and 2001/82/EC are amended by Directives 2004/27/EC and 2004/28/EC respectively legally permitting the EDQM to ask national inspection services to collaborate on inspections of manufacturing and distribution sites for raw materials for pharmaceutical use and legally recognising the role played by the General European Network of OMCLs (GEON) in independent testing.

2003

Annex 1 of Directive 2001/83/EC is revised and adopted under Directive 2003/63/EC maintaining the mandatory character of European Pharmacopoeia Monographs when requesting marketing authorisation (MA) for medicinal products for human and veterinary use.

2001

Directives 2001/82/EC and 2001/83/EC on medicines for human and veterinary use are codified to supersede all previous directives; thus maintaining the mandatory character of European Pharmacopoeia Monographs when requesting marketing authorisation.

1997

A contract is signed with the European Medicines Agency (EMA) allowing a sampling and testing programme for centrally authorised products (CAP).

1996

The European Directorate for the Quality of Medicines (EDQM) is created.

1994

The European Union becomes a party to the Convention acting on behalf of its member states for non-technical decisions; a contract is signed between the Commission of the European Union and the Council of Europe's European Pharmacopoeia Secretariat to set up a European network of Official Medicines Control Laboratories (OMCLs); the Procedure for the Certification of Suitability comes into force.

1993

A Memo of Understanding is signed with the European Committee for Standardisation (CEN) concerning medical devices.

1991
A contract is signed between the Commission of the European Communities and the Council of Europe putting the European Pharmacopoeia Secretariat in charge of a biological standardisation programme; Directives 91/507/EEC and 92/18/EEC revise Directives 75/318/EEC and 81/852/EEC respectively allowing all medicines, notably biologicals, to be covered by EU law; the EDQM participates in the International Conference on Harmonisation (ICH).

1990
The Pharmacopoeial Discussion Group (PDG) is set up with the United States Pharmacopoeia (USP) and the Japanese Pharmacopoeia (JP).

1989
A Protocol to the Convention on the Elaboration of a European Pharmacopoeia is signed to prepare the way for the European Community to be become a full member.

1981
Council Directive 81/852/EEC of 28 September 1981 makes compliance with European Pharmacopoeia Monographs mandatory when requesting marketing authorisation for medicines for veterinary use.

1975
Council Directive 75/318/EEC of 20 May 1975 makes compliance with the European Pharmacopoeia Monographs mandatory when requesting marketing authorisation for medicines for human use.

1967
The first laboratory is inaugurated making adoption, by the European Pharmacopoeia Commission, of the first texts on general methods for chemical, physical and physio-chemical analysis possible.

1964
The Convention on the Elaboration of a European Pharmacopoeia was opened for signature. The World Health Organisation (WHO) and the European Community become observers.

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