MHRA Consultation – Clinical Trials – Draft Guideline on the Use of External Control Arms Based on Real-World Data MHRA is inviting feedback on the clarity and wording of their new draft guideline on the use of external control arms (ECAs) based on real-world data (RWD) to support regulatory decisions. MHRA Consultation – Clinical Trials – Draft Guideline on the Use of External Control Arms Based on Real-World Data
MHRA Performance Data – April 2025 MHRA has published its performance data for April 2025. MHRA Performance Data – April 2025
MHRA Table of Approved Reclassifications Updated MHRA has updated the table of approved reclassifications found on MHRA's 'medicines: reclassify your product' guidance page. There are 2 new entries since the table was last updated. MHRA Table of Approved Reclassifications Updated
MHRA Consultation Response – ICH E6 (R3) Guideline for Good Clinical Practice Annex-2 The MHRA's response to the consultation on the International Council for Harmonisation (ICH) E6 (R3) Guideline for Good Clinical Practice (GCP) Annex-2 has been shared. MHRA has used the responses to the consultation to deliver feedback from UK stakeholders to the ICH. MHRA Consultation Response – ICH E6 (R3) Guideline for Good Clinical Practice Annex-2
MHRA – Consultation on new ICH Bioequivalence Guideline The MHRA is consulting with UK stakeholders on a new ICH guideline on Bioequivalence (BE) studies for Immediate-Release Solid Oral Dosage Forms. MHRA – Consultation on new ICH Bioequivalence Guideline
New EPR Guidance for ‘Small Producers’ Organisations classed as 'small producers' must register and report packaging data annually to comply with the EPR scheme as detailed in the new Defra guidance. New EPR Guidance for ‘Small Producers’
MHRA Marketing Authorisations Granted 15 to 30 April MHRA granted 4 OTC licences during 15-30 April 2025. MHRA Marketing Authorisations Granted 15 to 30 April
MHRA NIMAR Guidance Updated MHRA has published an updated version of the the Northern Ireland MHRA Authorised Route (NIMAR) guidance. This update includes revisions related to advertising and promotions, as well as information aligned with the Windsor Framework. NIMAR provides a route for the lawful supply of Prescription-Only Medicines in compliance with UK and EU rules, where there is a risk that clinical need in Northern Ireland for that product cannot be met. MHRA NIMAR Guidance Updated
MHRA RegulatoryConnect Webinar MHRA will be hosting a webinar on RegulatoryConnect on Thursday 22 May between 3.30-5pm. The aim of the webinar is to provide a comprehensive update on the programme, share plans for 25/26 and discuss some of the changes users will see, to help them prepare for the next release. MHRA also plan to share ongoing opportunities for feedback and involvement. MHRA RegulatoryConnect Webinar
CMDh April 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 23-24 April 2025. CMDh April 2025 Meeting – Report
AESGP Webinar – Ethanol BPR & CLP Procedures Impact on Self-care Products Greece has submitted a CLH Registry of Intention for Ethanol hazard classification including Repr. 2. To explore the potential impact of a CMR1A or CMR1B classification on self-care products, AESGP is hosting a webinar on Thursday 15 May 12.30–13.30 CEST. AESGP Webinar – Ethanol BPR & CLP Procedures Impact on Self-care Products
MHRA Webinar on Medicines Licensing: New National Assessment Procedure for Medicines MHRA is hosting a webinar on Medicines Licensing: New National Assessment Procedure for Medicines on Tuesday 6 May 2025, 10:00 - 11:00 BST. MHRA Webinar on Medicines Licensing: New National Assessment Procedure for Medicines
