INTERNATIONAL NEWS DECEMBER 2016

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EMA Management Board: highlights of December 2016 meeting

Board adopts work programme and budget 2017 and hears Brexit update.

The Management Board of the European Medicines Agency (EMA) heard from Executive Director Guido Rasi how the Agency is preparing for the possible exit of the United Kingdom (UK) from the European Union (EU). The extent of the impact of Brexit on the Agency’s operations and location is uncertain and will depend on the future relationship between the EU and the UK.
Depending on the outcome of the negotiations, this could cause significant disruption to the Agency’s operations and business continuity plans will need to be in place. As part of its preparedness, the Agency will continue carrying out impact assessments to identify the main risks and propose possible mitigating measures to maintain the Agency’s ability to protect public health.

Tailored scientific advice to support step-by-step development of new biosimilars

The European Medicines Agency (EMA) will launch a pilot project in February 2017 to test the added value and feasibility of tailored scientific advice for the development path of biosimilar medicines. Through this new initiative, EMA aims to provide developers of biosimilars with advice on the studies/tests they should be conducting, on the basis of the quality, analytical and functional data they have already available for the medicine.

This is expected to better support the stepwise development of biosimilars that is recommended in European Union (EU) guidelines. According to this approach, the extent and nature of the studies/tests required depend on the level and robustness of data already accumulated. Read the news on EMA’s website.