MHRA – Parallel Import Variation Tell-and-Do (TaD) Cover Sheet MHRA has updated the 'Parallel Import Variation Tell-and-Do (TaD) Cover Sheet' in the guidance 'medicines: apply for a parallel import licence'. MHRA – Parallel Import Variation Tell-and-Do (TaD) Cover Sheet
EMA ICH Consultation – Q3E Draft Guideline for Extractables and Leachables & Supporting Documentation The European Medicines Agency (EMA) has published for public consultation the draft International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3E Guideline for extractables and leachables and ICH Q3E Guideline for extractables and leachables - supporting documentation: class 3 leachable monographs. EMA ICH Consultation – Q3E Draft Guideline for Extractables and Leachables & Supporting Documentation
Exclusive Webinar – Understanding the Life Sciences Innovative Manufacturing Fund (LSIMF) The OLS and PAGB are hosting a special webinar, exclusive to PAGB members, marking one year since the launch of the Life Sciences Innovative Manufacturing Fund (LSIMF) Exclusive Webinar – Understanding the Life Sciences Innovative Manufacturing Fund (LSIMF)
10-Year Health Plan – Parallel Decision Making over Licencing (MHRA) and Value (NICE) The MHRA and the National Institute for Health and Care Excellence (NICE) have described how the 10-Year Health Plan will lead to faster new medicines access for patients in the NHS in England, through parallel decision making over licencing and value 10-Year Health Plan – Parallel Decision Making over Licencing (MHRA) and Value (NICE)
DHSC – Industry Placements The Department of Health and Social Care (DHSC) has run over 30 placements with more than 150 DHSC colleagues since last year. DHSC is now looking to secure new placements. DHSC – Industry Placements
New Chief Executive Appointed at UKHSA The government has announced the appointment of Professor Susan Hopkins as the new CEO of the UK Health Security Agency (UKHSA). New Chief Executive Appointed at UKHSA
TOPRA Course: CRED Prescription to Non-Prescription Medicines Switch in EU PAGB's CEO Michelle Riddalls OBE will be presenting at a new TOPRA course ‘CRED Prescription to Non-Prescription Medicines Switch in EU’ which will take place online on 8 October between 9:15am – 5pm (GMT). TOPRA Course: CRED Prescription to Non-Prescription Medicines Switch in EU
EU MDR – Table Listing Language Requirements Updated The European Commission has updated its previously published overview tables for the EU MDR and IVDR listing the language requirements at national level for manufacturers concerning information and instructions accompanying the device. EU MDR – Table Listing Language Requirements Updated
MHRA Marketing Authorisations Granted 1 to 14 August 2025 MHRA granted 1 OTC licence during 1 - 14 August 2025. MHRA Marketing Authorisations Granted 1 to 14 August 2025
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
