Last week the Regulation on Clinical Trials (“CTR”) finally became effective in the European Union (“EU”) and replaced the prior Clinical Trials Directive 2001/20 (“CTD”). The CTR was adopted in 2014 and was meant to enter...more
2/9/2022
/ Clinical Trials ,
Data Privacy ,
Deadlines ,
Disclosure Requirements ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Life Sciences ,
Member State ,
New Regulations ,
Proposed Regulation ,
Reporting Requirements ,
UK
The European Commission (Commission) has released a Staff Working Document concerning its joint evaluation of the Orphan Regulation and the Paediatric Regulation (collectively, the Regulations) (Joint Evaluation) and an...more
The European Commission ("Commission") presented the results of the stakeholders’ consultation on its "Note on Handling of Duplicate Marketing Authorisation Applications" ("Note on Duplicates") during the Pharmaceutical...more