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EMA senior officer: pharmaceutical companies encouraged to prepare for Brexit

Agnès Saint-Raymond, MD, Head of International Affairs at the European Medicines Agency (“EMA”), recently urged pharmaceutical companies to be “proactive” in preparing for Brexit, as there is still uncertainty around a...more

FDA, EU Regulators Agree to Share Unredacted Inspection Reports and Other Confidential Information

The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current...more

The EU Court of Justice dismisses EMA's appeals in interim measures and suspends the release of clinical study report to third...

On March, 1st 2017, by Order of its Vice-President, the Court of Justice of the EU (“CJEU”) upheld the suspension of the release to third parties of a clinical study report concerning the medicinal product Translarna granted...more

EMA public consultation on revised policy on access to documents

The EMA has launched a public consultation on its draft new Policy/0043 on access to documents. The document describes the EMA’s approach in balancing public and private interests involved in requests for access to documents...more

EU - US mutual recognition of GMP inspections: agreement published

On 4 March 2017, the agreement between the EU and the US governing the reciprocal recognition of GMP inspections of manufacturing sites for medicinal products for human use was published in the Official Journal of the EU:...more

EMA pilot project on tailored scientific advice to support new biosimilars

In February 2017, the European Medicines Agency (“EMA”) will launch a pilot project to provide tailored scientific advice for the development of new biosimilars, i.e. biological medicinal products that are similar to a...more

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