Latest Regulatory Updates |
|
Hello and welcome to the Boyds Regulatory Intelligence Digest. In this edition, we are sharing the latest guidance, insights and key developments from the regulatory agencies - FDA, EMA, and MHRA.
To discuss any of these updates, please contact a member of the Boyds Regulatory team who will be happy to help.
Check out our latest 'Conversations in Drug Development' podcast episode, which is out now: From lab to launch: avoiding the pitfalls of drug development. Listen here.
You can also meet the team at BIO next week - find us on the partnering app, or drop us a line if you would like to arrange a meeting.
|
|
|
|
Food and Drug Administration (FDA) |
|
European Medicines Agency (EMA) and the European Union (EU) |
|
Draft Act: Establishment of an expert panel on orphan and pediatric devices The European Commission plans to establish an expert panel on orphan and paediatric devices. The public feedback period ends 16 June 2025, and the act is planned to be adopted by The Commission in Q2 2025.
Draft ICH Q1 drug substance and drug product stability This draft revision to ICH Q1 aims to consolidate ICH Q1A-F and Q5C guidelines to provide a single comprehensive stability guideline that addresses a range of product types. Notably, the draft guideline provides stability considerations for advanced therapies, as well as short-term and in-use storage conditions. Once final, ICH Q1 will supersede ICH Q1A-F and Q5C. A complete summary of proposed changes in ICH Q1 is available here.
Devices
EUDAMED Workshop - 21 May 2025 - Stuttgart, Germany
Presentations are now available from the EUDAMED Workshop held in Stuttgart in May of this year that covered a range of topics such as:
- Introduction and regulatory framework to the European Database on Medical Devices (EUDAMED)
- Actors
- UDI/Devices
- Notified Bodies & Certificates
- Market Surveillance
Meeting presentations and recordings are available here.
|
|
Medicines and Healthcare products Regulatory Agency (MHRA), HRA & GOV.UK |
|
Webinar: Decentralized manufacturing regulations update (MHRA) (17 Jun 2025)
Ahead of new regulations coming into effect on 23 July 2025, MHRA will host a webinar to provide information on where to find the latest information and guidance on decentralized manufacturing, illustrative examples which the new regulatory framework will enable, and a Q&A session. This is a follow-up to the first webinar on this topic, hosted on 25 January 2025, which provides a general overview of the new regulation.
Devices
Webinar: Digital mental health technology (DHMT) NHR hosted a webinar that took place on Thursday, 15 May 2025, to provide a deep dive exploration of the recently published guidance on the characterisation, qualification, and classification of digital mental health technologies as Software as a Medical Device (SaMD). A recording of the webinar is now available to view here. |
|
|
|
Established in 2005, Boyds provides a range of expertise and skills central to the development of pharmaceutical and biotechnology medicinal products.
Boyds has offices in Cambridge, Cheshire, Dublin and Pennsylvania.
Copyright © 2025 Boyds, All rights reserved.
Our mailing address is:
Alan Boyd Consultants
Electra House
Crewe Business Park
Crewe, Cheshire CW1 6GL
United Kingdom
You are on our list either because you are a valued contact of ours, or we have worked together in the past, or we could work together in the future, or you have asked to receive these updates. If you do not wish to receive these occasional emails from us, please click on the unsubscribe button or update your preferences.
Unsubscribe from these emails
Update your Email Preferences
|
|
|
|
|
|
.jpg)
