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 EDQMbecomes 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).
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.
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.
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.
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.
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.