ATMPs, Medicine Shortages & CTR: April 2022 Pharma News
EU Clinical Trials Regulation Implemented
The EU Clinical Trials Regulation 536/2014 was finally implemented on January 31, 2022. On the same day, the 2010 version of EU GMP Annex 13 was replaced by the revised GMP for IMPs that had been waiting for implementation since it was published in 2017. There is uncertainty about where this will sit in the EU guidance structure, with the possibility that it may act as a revised Annex 13 or go elsewhere.
UK to Continue to Apply January 2010 Annex 13
On February 10, the UK MHRA announced that pending completion of the UK’s future clinical trial legislation, MHRA will continue to apply the January 2010 version of Annex 13 with respect to:
- Labeling requirements
- Two-step release procedure
- Handling and shipping of IMPs
- Contractual arrangements between the trial sponsor and IMP manufacturer
EMA Establishing European Shortages Monitoring Platform
A new Regulation 2022/123 was published in the Official Journal on January 31, 2022, and becomes applicable as of March 1, 2022, except for the provisions on shortages of critical medical devices, which will apply as of February 2, 2023. This new regulation gives the EMA a tool for monitoring medicines supply and preventing shortages in the event of a major public health crisis, such as a future pandemic.
The EMA is responsible for setting up and managing a new European Shortages Monitoring Platform to facilitate the gathering of information on drug shortages, supply and demand. This electronic platform will need to be able to determine the volume of stock available at any given moment and to detect, predict and prevent shortages. The EMA will also maintain a public web page with information on shortages of critical medicines and devices. It is expected that the new platform will be operational by early 2025.
NSF explored the issue of drug shortages in a recent webinar. You can watch it below:
The ABPI (Association of the British Pharmaceutical Industry) and AAC (Accelerated Access Collaborative) launched at the end of 2021 an “ATMP Roadmap” that has been created on their behalf by Ernst & Young with input from several UK organizations, including the Cell and Gene Therapy Catapult, the Medicines and Healthcare Products Regulatory Agency (MHRA), NHS England (NHSE) and the National Institute for Health and Care Excellence (NICE). This is a very useful resource for anyone involved with these products.
The ATMP Roadmap exists in the form of a downloadable interactive PDF and sets out the key steps and activities in the end-to-end pathway for advanced therapy medicinal products (ATMPs) in England, from nonclinical research through to patient treatment. It also signposts where differences exist between devolved nations (Scotland, Wales and Northern Ireland) or various types of ATMPs.