The EU and International Cooperation in Pharmaceuticals

01 July 2009
by inadim -- last modified 09 July 2009

The European Commission is an active member of the World Health Organisation’s International Medical Products Task Force (IMPACT). IMPACT counts all the major anti-counterfeiting players including international organizations, non–governmental organisations, enforcement agencies, pharmaceutical manufacturers associations and drug regulatory authorities.

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). IMPACT counts all the major anti-counterfeiting players including international organizations, non–governmental organisations, enforcement agencies, pharmaceutical manufacturers associations and drug regulatory authorities.   

Although counterfeit remains more prevalent in developing countries, with  international markets opening up to globalisation the problem has extended to all countries and the risk for counterfeit medicines to enter 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%.

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

For more information on Commission initiatives to fight counterfeit click here

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 a 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 that request it. The ICH observers (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 the 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 “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.

 

2009 European Commission