Final Revised EMA Guideline on the Pharmaceutical Quality of Inhalation and Nasal Medicinal Products EMA has published the final revised Guideline on the pharmaceutical quality of inhalation and nasal medicinal products. The guideline comes into effect on 1 February 2026. Final Revised EMA Guideline on the Pharmaceutical Quality of Inhalation and Nasal Medicinal Products
Update from UK ePI Task Force: Publication of Government’s Life Sciences Sector Plan An update from the UK Electronic Patient Information (ePI) Task Force on the Government’s Life Sciences Sector Plan has been shared. Update from UK ePI Task Force: Publication of Government’s Life Sciences Sector Plan
MHRA Consultation on ICH E20 Guideline on Adaptive Designs For Clinical Trials MHRA has launched a consultation on the International Council for Harmonisation (ICH) E20 Guideline on adaptive designs for clinical trials. The consultation closes at 11:59pm on 30 November 2025. MHRA Consultation on ICH E20 Guideline on Adaptive Designs For Clinical Trials
MHRA Marketing Authorisations Granted 1 to 14 July 2025 MHRA granted 2 OTC licences during 1 - 14 July 2025. MHRA Marketing Authorisations Granted 1 to 14 July 2025
European Commission Consultation – GMP Guidelines Chapter 4, Annex 11 and New Annex 22 The European Commission has launched a public consultation on a revised Good Manufacturing Practice (GMP) Chapter 4, Annex 11 and the introduction of a dedicated Annex 22 on Artificial Intelligence (AI). European Commission Consultation – GMP Guidelines Chapter 4, Annex 11 and New Annex 22
MHRA Marketing Authorisations Granted 15 to 30 June 2025 MHRA granted 2 OTC licences during 15 - 30 June 2025. MHRA Marketing Authorisations Granted 15 to 30 June 2025
MHRA Marketing Authorisations Granted 1 to 14 June 2025 MHRA granted 8 OTC licences during 1 - 14 June 2025. MHRA Marketing Authorisations Granted 1 to 14 June 2025
EMA RWD Report The European Medicines Agency (EMA) has published a third report based on studies EMA conducted using real-world data (RWD) between February 2024 and February 2025. The report summarises the progress made to enable the use of RWD and establish its value in regulatory decision-making. EMA RWD Report
DHSC – Review of Patient Safety Across the Health and Care Landscape Dr Penny Dash’s review of patient safety across the health and care landscape in England, which was commissioned by the Department of Health and Social Care (DHSC), has been published. DHSC – Review of Patient Safety Across the Health and Care Landscape
MHRA Consultation on ICH E21 Guideline on the Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials MHRA has launched a consultation on the International Council for Harmonisation (ICH) E21 Guideline on the inclusion of pregnant and breast-feeding individuals in clinical trials. The consultation closes at 11:59pm on 5 September 2025. MHRA Consultation on ICH E21 Guideline on the Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials
Launch of European Life Sciences Strategy The European Commission has launched the European Life Science Strategy - 'Choose Europe for life sciences - A strategy to position the EU as the world’s most attractive place for life sciences by 2030'. Launch of European Life Sciences Strategy
WHO Webinar on Collaborative Registration Procedures – 10 July 2025 The World Health Organization (WHO) is organising a webinar focussed on the dissemination of the revised guidelines on good practices for implementing the Collaborative Registration Procedure (CRP) for medicinal products. The webinar will take place on Thursday 10 July. WHO Webinar on Collaborative Registration Procedures – 10 July 2025
