Relations with European and international organisations

The EU and the Council of Europe

The European Commission has very close working relations with the Council of Europe in the area of the quality control of medicines, through the European Department for the Quality of Medicines and Healthcare (EDQM).

The EDQM provides the secretariat of the Commission of the European Pharmacopoeia. This elaborates the European Pharmacopoeia, established in 1964, under the aegis of the Council of Europe to promote public health, through the provisions of recognised common standards for use by healthcare professionals and others concerned with the quality of medicines. In 1989 the Protocol to the Convention on the Elaboration of a European Pharmacopoeia prepared the way for the European Community to become a full member by modifying certain provisions of the Convention and establishing the respective areas in which the European Commission and its Member States may act. The rules established by the monographs of the European Pharmacopoeia are mandatory for all pharmaceutical products and their constituents and contribute to the harmonisation of technical requirements for the authorisation, manufacture and storage of medicinal products.

Since then collaboration with the EDQM has considerably evolved and it contributes to developing a high quality system for medicines and other substances in the EU as required by EU pharmaceutical legislation. Today the Commission supports the work of the EDQM in areas related to the development of quality standards for medicinal products, the system of official control authority batch release (OCABR), the certification of substances, the standardisation of biological products and the network of National Official Medicines Control Laboratories (OMCL). The Commission also participates in the Commission of the European Pharmacopeia and in various other EDQM scientific and technical committees.

The EU and the World Health Organisation

The Commission is an active member of the World Health Organisation's International Medical Products Task Force (IMPACT).

The taskforce was created in 2006 in response to the growing public health crisis of counterfeit medicines and it aims to build coordinated networks across and between countries in order to halt the production, trading and selling of fake medicines throughout the world. IMPACT counts all the major anti-counterfeiting players, including international organisations, non-governmental organisations, enforcement agencies, pharmaceutical manufacturers' associations and drug regulatory authorities.

Although counterfeiting remains more prevalent in developing countries, with international markets opening up to globalisation, the problem has extended to all countries and the risk of counterfeit medicines entering the EU through illegal distribution channels has increased. Between 2005 and 2007 the number of counterfeit medicines seized at the EU boarder has increased by 380%.

Counterfeiting represents a serious threat to global health and thus calls for a comprehensive strategy both at European and international level.

Further information on Commission initiatives to fight counterfeiting.

The EU and the International Conference on Harmonisation (ICH)

The European Commission plays an important role in the International Conference on Harmonisation (ICH) to promote international harmonisation, thereby reducing the resources needed for the development of medicinal products, and to minimise the risk that sub-standard products enter the EU market. EU cooperation on international technical harmonisation issues with the United States of America and Japan in the framework of the International Conference on Harmonisation (ICH) is essential in this context.

The ICH was launched in 1990 as a joint regulatory/industry project to make new pharmaceutical development and registration processes more efficient in the interests of patients, public health and cost-effectiveness. Technical requirements for demonstrating the quality, safety and efficacy of new medicines have been largely harmonised between the European Union, the United States and Japan via the ICH.

International Conference on Harmonisation Global Cooperation Group (GCG)

To promote mutual understanding of regional harmonisation initiatives and in order to facilitate the harmonisation process, the International Conference on Harmonisation Global Cooperation Group (GCG) was formed in 1999. Its role is to make available information on ICH activities and guidelines to regulatory authorities and pharmaceutical companies which request it. The ICH observers (the WHO, Canada and EFTA) are also part of the GCG. The GCG today serves as a unique forum for the discussion of harmonisation topics and practices.

The EU and International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)

The ICH successes in harmonising regulatory requirements for human medicines inspired the launch in 1996 of a similar harmonisation drive for veterinary medicines, known as the "International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products" (VICH), under the auspices of the International Office of Epizootics (OIE). Besides the EU, Japan and the United States, VICH includes Australia, Canada and New Zealand, as observers.