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Julia Gillert


The Heads of Medicine Agency has published a letter highlighting its plans to collaborate with other European medicines agencies to build knowledge on the approaches taken by member states with a record of effective, consistent trial reporting, with a view to sharing guidance with all member states as to “best practice” clinical trial reporting ahead of the new Clinical Trial Regulation and enhanced transparency rules coming into force. This article sets out the reasoning behind the letter’s publication, as well as an overview of key provisions within the CTR.

Following four and a half years of often acrimonious negotiations and numerous build ups to a no-deal situation, the EU-UK TCA represents a positive step. While the deal is relatively thin and offers only discrete regulatory reciprocity, overall the TCA is a welcome development in the face of apparent near- political failure to agree on a way forward between the two sides. The life sciences sector has been preparing for no-deal amidst the global coronavirus (COVID-19) pandemic, throughout 2020, and having a deal, however slim, is positive for the sector in providing more fertile political ground for future harmonisation and cooperation

The EU has urged member countries to grant more legal powers to the EU in pursuit of a ‘Health Union’, which would enable the EU to better manage future crises. This announcement comes in the wake of the COVID-19 pandemic, which exposed areas of weakness and gaps in the EU’s health powers. Critics argue that the pandemic has seen a lack of effective measures to monitor medicines shortages, that the EU Infectious Diseases Agency’s advice lacked effectiveness, and that there was a disjointed approach to the virus across EU member states. In response, the Commission expressed desire to make the following changes:

create an EU-wide pandemic preparedness plan
align testing methods with EU labs
give the European Medicines Agency (EMA) more power to mitigate drug shortages

Read publication  Welcome to the October 2019 edition of our newsletter. The EMEA Healthcare Industry Group Newsletter is your regular digest of legal developments affecting the life science and healthcare industries across the region. In this issue: Europe • General presumption of confidentiality of clinical study reports: Opinion of AG…