MHRA Performance Data – July 2025 MHRA has published its performance data for July 2025. MHRA Performance Data – July 2025
MHRA Clinical Trials Route B Substantial Modifications Pilot MHRA has published guidance on the clinical trials Route B substantial modifications pilot which starts on 1 October 2025. MHRA Clinical Trials Route B Substantial Modifications Pilot
DHSC Publishes Policy Paper on Managing a Robust and Resilient Supply of Medicines This policy paper highlights DHSC and NHS England’s ongoing work and future plans to improve shortage management and strengthen medicines supply chain resilience. DHSC Publishes Policy Paper on Managing a Robust and Resilient Supply of Medicines
MHRA Marketing Authorisations Granted 15 to 31 July 2025 MHRA granted 6 OTC licences during 15 - 31 July 2025. MHRA Marketing Authorisations Granted 15 to 31 July 2025
MHRA Application Forms update – Change Of Ownership and Cancellation MHRA has updated the forms used to submit a Change of Ownership or a Marketing Authorisation Cancellation. MHRA Application Forms update – Change Of Ownership and Cancellation
EMA Consultation – Concept Paper on the Use of External Controls for Evidence Generation in Regulatory Decision-Making The EMA has launched a public consultation on a draft concept paper on the development of a reflection paper on the use of external controls for evidence generation in regulatory decision-making, closing on 31 October 2025. EMA Consultation – Concept Paper on the Use of External Controls for Evidence Generation in Regulatory Decision-Making
EU – Biotech Act Public Consultation The European Commission has launched a public consultation on the Biotech Act, closing on 10 November 2025. EU – Biotech Act Public Consultation
MHRA Designated as WHO-Listed Authority MHRA has been designated as a WHO-Listed Authority (WLA) by the World Health Organization (WHO). MHRA Designated as WHO-Listed Authority
CMDh – Publication of assessment reports from the Harmonisation of RMP Project (HaRP) The assessment reports (AR) from the Harmonisation of Risk Management Plans (RMP) Project (HaRP) peer review group have now been published. CMDh – Publication of assessment reports from the Harmonisation of RMP Project (HaRP)
EMA Industry Standing Group June 2025 – Highlight Reports The European Medicines Agency (EMA) has published its Highlight Report from the Industry Standing Group (ISG) meeting that took place on 30 June 2025. EMA Industry Standing Group June 2025 – Highlight Reports
A message from MHRA – Change in the Management of Windsor Framework Labelling Requirements MHRA's message to companies regarding changes in the management of Windsor Framework labelling requirements from 1 August 2025. A message from MHRA – Change in the Management of Windsor Framework Labelling Requirements
MHRA Updates Category 1 and 2 Lists Following Windsor Framework Implementation The MHRA has updated the category lists following the implementation of the Windsor Framework. MHRA Updates Category 1 and 2 Lists Following Windsor Framework Implementation
