La Haute Autorité de Santé et l’Agence Nationale de Sécurité du Médicament publient aujourd’hui un premier bilan du dispositif d’autorisation d’accès précoce (AAP) aux médicaments, mis en place le 1er juillet 2021. Read the news...
The ISSCR submitted comments to the UK’s MHRA on the Consultation on Point of Care Manufacturing that state, among other key points: We are particularly concerned that purveyors of autologous adipose-derived cell therapies might seek to exploit...
The MHRA hosted a public consultation on a proposed statutory instrument for the Early Access to Medicines Scheme (EAMS) from the 6th of August to 17th September 2021. The consultation was carried out to obtain...
Significant clarification of the life-changing EAMS scheme to be introduced into law. Read the press release from Medicines and Healthcare products Regulatory Agency published on 2 February 2022.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report. Read the news from Medicines and Healthcare products Regulatory Agency updated on 7 February 2022.
A list of authorised orphan medicinal products registered by the UK Licensing Authority. Read the news from Medicines and Healthcare products Regulatory Agency updated on 9 February 2022.
List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months...
We’re looking for your views on how medical devices will be regulated across the United Kingdom (UK) in the future. This consultation ran from 11:30am on 16 September 2021 to 11:45pm on 25 November 2021....
Ten guiding principles that can inform the development of Good Machine Learning Practice (GMLP). Read the news from Medicines and Healthcare products Regulatory Agency published on 27 October 2021.
These principles are intended to lay the foundation for developing good machine learning practices (GMLP) and will help guide future growth in this rapidly progressing field. Read the news from Medicines and Healthcare products Regulatory...
