This is a follow up to our previous posts relating to the European Medicines Agency’s (EMA) various policies on access to documents. This continues to be an area of activity for the EMA and there have been a number of developments that have impacted the EMA’s position. Firstly, Brexit has directly affected one of the main pillars of the transparency activities of the EMA, namely the proactive publication of clinical trial data submitted by pharmaceutical companies in support of certain types of regulatory submissions to the Agency (the EMA’s Policy 0070).
Secondly, while the reactive transparency activities of the EMA relating to access to documents in accordance with Regulation (EC) No 1049/2001 (the EMA’s Policy 0043) have been less affected by Brexit, there may be other challenges for the EMA ahead.
Continue Reading Latest Developments in the Transparency Activities of the European Medicines Agency