The Faculty of Pharmaceutical Medicine (FPM) welcomes the recent announcement by the Medicines and Healthcare Products regulatory Agency (MHRA) (UK) that it is to join two international collaborations; Project Orbis which focuses on cutting-edge cancer treatment, and the Access Consortium, to help secure faster patient access to high quality, safe and effective medicines.
Project Orbis is a programme coordinated by the US Food and Drug Administration involving health regulatory authorities in Canada, Australia, Switzerland, Singapore and Brazil and which focuses on cutting-edge cancer treatments. The scheme has already given the approval to many life-saving treatments for patients suffering from conditions such as breast cancer, lung cancer, liver cancer, endometrial cancer, and chronic lymphocytic leukaemia.
Access Consortium involves health regulatory partners from Australia, Canada, Switzerland and Singapore working together to share research and improve timely patient access to high quality, safe and effective medicines.
FPM welcomes these important developments, which are intended to continue the good working relationships MHRA has traditionally had with the FDA and other international regulators via the ICMRA group. It is likely to ensure that the UK continues to be a destination participant in clinical development trials, as well as enabling early access to expanded data, supporting the potential for earlier approval of important medicines, particularly in oncology.
“This strengthens the position of the UK in global regulation and emphasises the important concept of regulatory reliance, for which the UK has long been a strong advocate and champion. These collaborations help bring MHRA and UK expertise to the forefront across the world and will also help to ensure that the medicines used by the UK public have been subject to the highest level of multi-agency scrutiny.”