The European Medicines Agency has updated its guidance on the parallel distribution of medicinal products. ‘Parallel distribution’ refers to Centrally Authorised medicinal Products (‘CAPs’) put on the market of one member state that can be marketed in any other member state by a distributor, independently of the marketing-authorisation holder.
To access the guidance, see: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/parallel-distribution/frequently-asked-questions-about-parallel-distribution
The European Medicines Agency has updated its guidance on biological medicinal products (which takes the form of a ‘Q&A’ document). This includes:
The Q&A can be accessed here: https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/biologicals/questions-answers-biological-medicinal-products
The US FDA has issued a draft guidance document on remote inspections, titled ‘Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry’.
FDA describes how it requests and conducts voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, compounded, or held and at drug facilities covered under FDA’s bioresearch monitoring program.
This follows the practices that were required to be undertaken during the COVID-19 pandemic. Having developed the tools, the FDA is proposing using remote inspections as an additional tool.
The following platforms are required: Microsoft Teams, Zoom or Adobe Connect.
The draft guidance can be found here: https://www.fda.gov/media/173286/download
MHRA has issued a new document, titled ‘Guidance published on the new international regulatory recognition routes for medicines approvals’.
This guidance informs the sector on how they can use the scheme to apply for a medicine licence in the UK, following approval by trusted regulatory partners in Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States.
To access, see: https://www.gov.uk/government/publications/international-recognition-procedure
The MHRA, together with US Food and Drug Administration (FDA) and Health Canada, has collaborated to identify five guiding principles for the development of Predetermined Change Control Plans (PCCPs).
These guiding principles for PCCPs aim to remove the regulatory burden for developers of Machine-Learning-enabled Medical Devices (MLMDs), enabling reallocation of resources to improve product performance for patients.
This fits in with current guidance on Good Machine Learning Practice (GMLP).
These are:
The guidance can be found here: https://www.gov.uk/government/news/mhra-and-international-partners-publish-five-guiding-principles-for-machine-learning-enabled-medical-devices
Readers who are keen on keeping abreast of GxP developments might be interested in this quote from the MHRA Corporate Plan 2023-2026: “Introduce new guidance and legislation, building our status as an independent regulator in a global environment, to ensure the UK remains a great environment to develop novel and innovative medical products.”