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First application for FDA/EMA review pilot

Pfizer has submitted the first application for the European Medicines Agency's and the US Food and Drug Administration's 'quality by design' pilot for increased co-operation in drug evaluations

Pfizer has submitted the first application for the European Medicines Agency's (EMA) and the US Food and Drug Administration's (FDA) 'quality by design' pilot for increased co-operation in drug evaluations.

The voluntary pilot programme was announced in March 2011 to help ensure consistent implementation of certain guidelines from regulatory agencies when reviewing marketing applications for new drugs.

The programme is designed to encourage regular communication and consultation between the EMA and FDA during the assessment of the design and development of formulations and manufacturing processes listed in the application. This is to help ensure product manufacturing quality.

The pilot is being operated under the EMA's confidentiality arrangements with the FDA, covering issues related to medicinal products for human and veterinary use. In September 2010, the agencies said they would indefinitely extend these arrangements.

20th June 2011

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