On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
EMA confirms that access to clinical study reports for preparation of Health Technology Dossiers will be permitted within the new EMA Disclosure Policy
- use the clinical data to support an application for a marketing authorisation and any extensions or variations thereof for a medicinal product anywhere in the world;
- share the user’s username, password or other account details with a third party or otherwise provide a third party with access to the user’s account;
- make any unfair commercial use of the clinical data.
Similar conditions are imposed on users of the clinical data for the academic and other non-commercial research purposes referred to in Annex 2 to the Disclosure Policy. Any failure by the user to comply with these conditions would result in the revocation of the users' right to access and use the clinical data.
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...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017