The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 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.
On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory...03 January 2017
On 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders...03 January 2017