Guidance: CLOSED AI Airlock Phase 2 application
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Guidance: MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Medicines: Marketing Authorisation Holders' submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Five non-executive directors reappointed to the Medicines and Healthcare products Regulatory Agency Board
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Register medical devices to place on the market
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Clinical investigations for medical devices
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Statutory guidance: MHRA fees
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
MHRA CEO Lawrence Tallon welcomes Life Sciences Sector Plan
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Access, new active substance and biosimilar work sharing initiatives
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
MHRA approves sebetralstat (Ekterly) to treat hereditary angioedema (HAE) attacks in patients aged 12 and over
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Form: Medicines: variation forms for a manufacturer's licence
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Form: Medicines: application forms for a manufacturer licence
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Valproate – reproductive risks
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Decision: Parallel import licences granted in 2025
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Decision: Marketing authorisations granted in 2025
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Register medical devices to place on the market
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
FDA to Revoke 52 Obsolete Standards of Identity for Food Products
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Clinical investigations for medical devices
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Statutory guidance: MHRA fees
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
MHRA CEO Lawrence Tallon welcomes Life Sciences Sector Plan
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Clinical investigations for medical devices
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Access, new active substance and biosimilar work sharing initiatives
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
MHRA approves sebetralstat (Ekterly) to treat hereditary angioedema (HAE) attacks in patients aged 12 and over
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
Form: Medicines: variation forms for a manufacturer's licence
Dedicated subreddit for those interested or involved in Pharmaceutical research and development.
