We have previously discussed the changes to the regulation of medical devices both in the UK and the European Union in our May 2020 blog post here.  This post provides an update on the UK Medicines and Medical Devices Bill (the UK Bill), post-Brexit transition period guidance in the UK on the regulation of medical … Read more

The Unified Patent Court (UPC) took another step closer to coming into being on November 26 with a Bundestag vote passing the legislation necessary for Germany to ratify the UPC Agreement and the Protocol on Provisional Application with (more than) the two thirds majority found to be required by the German Federal Constitutional Court in … Read more

Paediatric Investigation Plans The legal requirements for UK Paediatric Investigation Plans (PIPs) from 1 January 2021 are set out in the Human Medicines Regulations 2012, as amended by the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019. Under the Human Medicines Regulations, results from an agreed PIP must be included in an application for … Read more

The UK government guidance How the MHRA will manage orphan medicinal products from 1 January 2021 in Great Britain (1 October 2020) confirms that the MHRA will offer incentives in the form of market exclusivity and refunds of MA fees for medicines to treat rare diseases. Read more

Once the UK leaves the EU, it will cease to participate in the European regulatory network for clinical trials, and regulatory responsibilities would shift to the MHRA. The UK government guidance Registration of clinical trials for investigational medicinal products and publication of summary results from 1 January 2021 (1 September 2020) and Guidance on substantial amendments to a clinical trial from 1 January 2021 (1 September 2020) set out the latest position in relation to clinical trials after the transition period ends. Read more

Comparator products for use in bioequivalence and therapeutic equivalence studies for Great Britain are covered in the UK government guidance Comparator products in Bioequivalence/Therapeutic Equivalence studies from 1 January 2021 (1 September 2020). The scope of the guidance only covers applications relating to generic medicinal products (regulation 51 of the Human Medicines Regulations 2012) and applications relating to certain medicinal products that do not qualify as generics (regulation 52 of the Human Medicines Regulations 2012), but the guidance makes clear that the principles may also be applicable for other forms of applications (Regulation 54, 55 and 65C of the Human Medicines Regulations 2012). Comparator products for applications in Northern Ireland continue to be covered by the EU requirements. Read more

The licensing of biological products (including biosimilars, advanced therapy medicinal products and plasma master files and vaccine antigen master files) from 1 January 2020 is covered by the Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019. The UK government guidance in relation to biological products is provided in the Guidance on licensing biosimilars, ATMPs and PMFs from 1 January 2021 (1 September 2020). Read more

The European Commission has this week published a wide-ranging and ambitious Pharmaceutical Strategy for Europe, and an Action Plan on Intellectual Property. Pharmaceutical Strategy for Europe The new pharmaceutical strategy for Europe is a key pillar of the European Health Union, which President von der Leyen called for in her 2020 State of the Union … Read more