Long-standing relationships continue with US and others

United States

EMA's most long-standing and well-documented relationship is with the FDA, with which it has had confidentiality arrangements in place since 2003. These arrangements became effective for an indefinite amount of time in September 2010. The increases in interactions between the two agencies have been driven by the Transatlantic Administrative Simplification Action Plan, which was established in 2007 to remove the administrative burden involved in interactions between regulators in Europe and the US (8). The initial plan outlined several projects, including collaborations on inspections (including in third countries), combating counterfeit medicines, safety reporting from clinical trials, exchange of information regarding policies to promote innovation in drug development, the development of biomarkers and joint agency validation of these with respect to product development and recommendations for advanced therapy medicinal products. An additional boost to cooperation was the appointment of a permanent representative from FDA to EMA's office in London in 2009. In 2010, the EMA followed suit with a permanent representative at FDA. One of the most recent initiatives was launched in January 2012 to share work on inspections of manufacturing sites in each other's territories. The general approach will use information exchange for sites and will generally focus on sites that are known to both agencies and that have a history of satisfactory GMP compliance (9).

Another important partner for EMA is the World Health Organisation (WHO), with whom it works on projects concerning medicines intended for markets outside of the EU, the quality of medicines and the development of international non-proprietary names (INNs). EMA provides support to WHO to assist in capacity building for regulatory bodies in emerging markets, and also participated in the WHO's "make medicines child size" initiative, which first launched in December 2007 (10). Few essential medicines exist in child-size dosage forms and there is often insufficient information about the paediatric use of such medicines. The EMA-backed initiative has identified certain research, development, regulatory, legislative and supply gaps that need to be addressed to ensure that children receive appropriate medicines, at the right dose and with enough supportive information for the prescriber. The priority areas for the initiative are HIV/AIDS, malaria, pneumonia, tuberculosis and diarrhoea.

India

In India, EMA works with regulators for the application of international standards in manufacturing and clinical trial activities with Indian regulators are invited to the agency's annual good-clinical-practice (GCP) inspector training. Indian regulators are under considerable domestic pressure to improve clinical trial standards in the country. In 2011, it was estimated that there were 438 deaths associated with clinical trials (11). Indian regulators have been attempting to strengthen their clinical trial regulations as a result, but critics continue to argue that their efforts are insufficient (11). Because many of the clinical trials in India have foreign sponsors, including some of the world's major pharmaceutical companies, Indian regulators are seeking advice from EMA and other bodies with long-standing experience in the field.

Russia

The EMA's work with Russia is part of the European Commission's existing arrangements with the country in the area of pharmaceuticals. In 2007, a dedicated EU–Russia regulatory dialogue subgroup on pharmaceuticals was launched and the EMA gets involved when there are scientific or technical issues to discuss.

Summary

Looking forward, EMA says that it views international cooperation as a core activity (2). Its current international strategy aims to improve communication and create synergies through collaboration with its partner regulators (2). Important international activities, in particular, include forming mutual-recognition agreements (MRAs) and other complementary arrangements.

As drug development occurs in an international environment, regulatory agencies must collaborate and there is renewed focus on such interactions through dedicated strategies formalising the processes involved. Regulators in all regions are also under increased pressure to improve their performance, but as public bodies they have limited resources at their disposal. Another reason, therefore, for the interest in regulatory collaboration is the ability to learn from the experiences of counterpart agencies, as well as avoiding duplication of work and facilitating synergic activities.