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
DHSC Public Appointments: April 2025 – March 2026 The Department of Health and Social Care (DHSC) has announced its non-executive appointments for the period from April 2025 to March 2026. DHSC Public Appointments: April 2025 – March 2026
Talc – CLP Category 1B Carcinogen Classification – Webinar Following the proposed harmonised classification and labelling at EU level of Talc as a category 1B carcinogen, EUROTALC is organising a webinar on 23 September 2025 16:00 to 17:30 CEST. Talc – CLP Category 1B Carcinogen Classification – Webinar
eLearning with PAGB: New EU Medical Devices Regulation Course This course covers the fundamental principles of medical device regulation in the EU, from borderline and classification, to market surveillance and EUDAMED. Perfect for beginners or as a refresher on the basics. eLearning with PAGB: New EU Medical Devices Regulation Course
Nitrosamines – EMA-HMA Report on EMRN Response to Impurities in Medicines The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have published a report outlining the European medicines regulatory network’s (EMRN) response to nitrosamine impurities in human medicines. Nitrosamines – EMA-HMA Report on EMRN Response to Impurities in Medicines
CMDh July 2025 Meeting – Report The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the report from the CMDh meeting held on 22-23 July 2025. CMDh July 2025 Meeting – Report
