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
New French Transparency Regulations Ruled Valid by French Constitutional Court
- disclose fees above a certain threshold (to be established by the government) paid under agreements with HCPs and with other stakeholders;
- report the purpose of the agreements in a more detailed manner, and not by generic descriptions;
- "direct" and the "final" beneficiary of the agreements will have to be reported.
The specifics of these changes will be established by an upcoming implementing decree.
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