News & Analysis as of

Clinical Trials Biotechnology European Union

A&O Shearman

A new European strategy to foster life sciences innovation and market access

A&O Shearman on

On July 2, 2025, the European Commission released its communication “Choose Europe for life sciences. A strategy to position the EU as the world’s most attractive place for life sciences by 2030” (the Strategy). ...more

Hogan Lovells

EU Clinical Trials Regulation to apply from December 2021

Hogan Lovells on

On 12 June 2020, the management board of the European Medicines Agency (EMA) announced December 2021 as the date of entry into application of the EU Clinical Trials Information System (CTIS). ...more

Hogan Lovells

What the European Medicines Agency’s qualification opinion means for electronic clinical data capture

Hogan Lovells on

The European Medicines Agency (EMA) issued a qualification opinion following a request concerning proprietary eSource DDC (Direct Data Capture) technology. This technology allows the capture of clinical study source data...more

Hogan Lovells

New EU draft guidelines on clinical trials with ATMPs open for consultation

Hogan Lovells on

The European Commission, together with the EMA and the expert group of the competent authorities of the EU Member States, has developed draft guidelines (the “Guidelines”) governing good clinical practice specific to advanced...more

Hogan Lovells

New rules for expanded access in Italy

Hogan Lovells on

Fast track for orphan diseases and rare forms of cancers - By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more

Hogan Lovells

EMA Update concerning EU Clinical Trials portal and database

Hogan Lovells on

Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was adopted and entered into force in 2014. The...more

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