A medicinal product containing only one of two active substances contained in an earlier product is not part of the global marketing authorisation and is, therefore, entitled to its own data protection period....more
The MHRA announced on Tuesday the biggest overhaul of clinical trial regulation in the UK in 20 years. The details of the amendments to clinical trial regulation are set out in the MHRA’s response to a public consultation...more
3/27/2023
/ Clinical Trials ,
Healthcare ,
Life Sciences ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
New Guidance ,
New Legislation ,
Pharmaceutical Industry ,
Proposed Regulation ,
Public Consultations ,
Regulatory Reform ,
UK ,
World Health Organization
The European Commission and the United Kingdom government announced on Monday that they have come to agreement on measures to alleviate the remaining practical difficulties in the supply of medicines to Northern Ireland that...more
The European Commission has moved to the next phase in its evaluation of the current EU pharmaceutical legislation and the potential for its reform by opening a 12 week online public consultation....more
The European Commission has announced that the Clinical Trials Regulation, already enacted in 2014, will take effect on 31 January 2022....more
As next generation Covid-19 vaccine developers consider whether ethical and practical clinical efficacy trials can be conducted, they might consider whether vaccine efficacy can instead be inferred. We consider the...more
This note discusses regulatory data protection (or data exclusivity) and market protection (marketing exclusivity). It identifies their legal bases, defines relevant legal terms and case law, and explains why these forms of...more