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 Medicines and Healthcare products Regulatory Agency has extended the EC Decision reliance procedure (EC DRP) to apply until 31 December 2023....more
On 24 January 2022, Mr Justice Meade handed down the latest main judgment in the ongoing litigation between Neurim (and Flynn) and Generics (UK) Ltd (trading as Viatris but formerly trading as Mylan), which has swiftly been...more
The Court of Appeal (Arnold LJ, Laing LJ and Birss LJ) handed down its judgment in Thaler v Comptroller General of Patents Trade Marks And Designs on 21 September 2021. The court held, with Birss LJ dissenting, that the judge...more
The European Commission has responded to pressure from the medical devices industry and has proposed an amendment to the In Vitro Diagnostics Regulation (“IVDR”, Regulation 2017/746) to introduce amended transitional...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
We have just witnessed the first moves by the United Kingdom government to diverge from the harmonised laws regulating medicines and medical devices that the UK inherited on leaving the European Union at the end of January...more
The Court of Appeal (Birss LJ, Floyd LJ and Phillips LJ) handed down its judgment in Fibrogen v Akebia on 24 August 2021, overturning Arnold LJ (another Court of Appeal judge) on his judgment on insufficiency when sitting at...more
The European Commission has announced that the Clinical Trials Regulation, already enacted in 2014, will take effect on 31 January 2022....more
In the latest UK medical technology (Medtech) patent decision Insulet v Roche Diabetes Care [2021] EWHC 1933 (Pat), Ms Pat Treacy (sitting as a judge of the High Court) held that (i) Roche Diabetes Care’s Accu-Chek Solo...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
The use of genome-editing techniques in medical therapies has proved to be a promising development in the treatment of certain diseases, such as cancer, HIV and rare diseases, by genetically altering specific types of cells....more