History

Key Milestones in Our History

2007

• A Memo of Understanding is signed with the Pharmaceutical Inspection Cooperation Scheme (PIC/S) which will facilitate the exchange of information and collaboration on inspections of APIs and blood.
• A Memo of Understanding is signed with the Heads of Medicines Agency which will facilitate the development of a common market surveillance programme for medicines that have been authorised by the mutual recognition (or the decentralised) procedure.
  
• A Memo of Understanding is signed with the Chinese authorities, represented by the Shanghai Food and Drug Administration (ShFDA) and the Shanghai Institute Food and Drug Control (SIFDC), which will facilitate the accessibility of European Pharmacopoeia reference standards in China.
• A Memo of Understanding is signed with the Shanghai Municipal Food and Drug Administration which will facilitate collaboration on analytical studies.
  
• The Council of Europe inaugurates the new EDQM headquarters on 20 March.
• A Memo of Understanding is signed with the Health Products and Food Branch (HBPB) of Health Canada that allows the filing of Certificates of Suitability with the Therapeutic Products Directorate thus avoiding the duplication of evaluations by Canadian and European authorities.
• A Memo of Understanding is signed with the National Institute for the Control of Pharmaceutical Biological Products (NICPBP) to collaborate on the publishing of a technical guide in Chinese.

2006

• The EDQM becomes responsible for two new activities: blood transfusion and organ transplantation. The organisation becomes known as the European Directorate for the Quality of Medicines & HealthCare.
• On 4 May, the EDQM is designated a WHO Collaborative Centre for International Standards for Antibiotics (ISA).

2004

• Directive 2001/83 EC and Directive 2001/82/EC were amended by 2004/27/EC Article 111 and 2004/28/EC Article 80 to legally permit the EDQM to ask national inspection services to collaborate on the inspection of manufacturing and distribution sites for raw materials for pharmaceutical use, and to legally recognise the role played by the European network of OMCLs in the area of independent testing.

2003

• Annex 1 of Directive 2001/83/EC was revised and adopted under the reference Directive 2003/63/EC. This amendment maintains the mandatory of the monographs but also the general monographs and monographs on dosage forms in marketing authorisation (MA) applications.

2001

• Directives 2001/82/EC and 2001/83/EC on medicines for human and veterinary use codify and supersede all previously published directives and maintain the mandatory character of European Pharmacopoeia monographs in the preparation of dossiers for MA applications.
  
  

1997

• The EDQM signs a contract with the European Medicines Agency (EMEA) allowing the organisation of a common sampling and testing programme for centrally authorised products (CAP). This contract is regularly renewed.
  

1996

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

1994

• On 21 June, the European Union becomes party to the Convention acting on behalf of its member states for non-technical decisions.
• A contract is signed on 26 May between the Commission of European Communities and the Council of Europe (Secretariat of the European Pharmacopoeia) to set up the European network of Official Medicines Control Laboratories (OMCLs). This contract is regularly renewed.
  
• The procedure for the Certification of Suitability comes into force on 1 April.