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EMA/FDA extend confidentiality arrangements

The European Medicines Agency and US Food and Drug Administration have extended shared confidentiality arrangements indefinitely

The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have extended shared confidentiality arrangements indefinitely.

The arrangements between the regulatory bodies cover issues related to medicinal products for human and veterinary use, with an initial deal signed in 2003. This has now been extended with no need for further renewal according to a statement from the EMA.

The deal allows both organisations to share confidential information as part of their individual regulatory and scientific processes.

According to the EMA, the aim of the arrangements is "to promote public and animal health and to protect European and US patients."

Specific types of information to be shared by the company, as stated in the original 2003 agreement, include:

• Good Clinical Practice inspection reports of clinical trial sites
• Drafts of pending laws, regulations and guidance documents
• Post-marketing data and information that could impact public health
• Information on defects or recalls known by one agency to have been manufactured or distributed in the other agency's territory

The new agreement will see its current implementations remain valid.

16th September 2010


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