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Regulators to improve cooperation on generic drugs

EMA to spearhead information sharing initiative

EMA logoEMA logoGlobal regulatory bodies are to improve cooperative efforts on generic drugs in an initiative spearheaded by the European Medicines Agency (EMA).

The EMA said it will share its assessments of marketing applications for generic medicines in 'real time' with agencies outside the EU, beginning with authorities in Australia, Canada, Chinese Taipei and Switzerland.

The aim of the project is to strengthen the global scientific assessment process for generic medicines, which can be launched once a branded drug loses patent and tend to be far cheaper than the original product.

As part of the initiative the EU will be able to share knowledge from its robust process to help improve the availability of safe and effective generic medicines in countries that do not have adequate resources in the area.

The plan to share improve regulatory cooperation on generic drugs is part of the International Generic Drug Regulators Pilot (IGDRP) launched by the World Health Organization (WHO) in April 2012 to “strengthen collaboration and convergence between regulatory agencies worldwide”.

Regarding the first phase of the pilot project ten applications for generic medicines will be selected, while further products might be considered after evaluation of first results.

Other countries signed up to the IGDRP that could take part in the project at a later stage include Brazil, China, Japan, Korea, Mexico, New Zealand, Russia, Singapore and South Africa.

The initiative is the latest in the EMA's attempts to improve collaboration with regulatory bodies across the world.

The agency has built links with the US FDA and other bodies on improving pharmacovigilance and is working with the WHO, the FDA and the Australian Therapeutic Goods Administration (TGA) to develop joint efforts to improve practices at drug manufacturing facilities.

20th January 2015

From: Regulatory



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