EMA HMPC Meeting Report – May 2025 The report from the EMA Committee on Herbal Medicinal Products (HMPC) meeting held on 5-7 May 2025 has been published. EMA HMPC Meeting Report – May 2025
JRC Consultation on EU Harmonised Label for Packaging Waste The Joint Research Centre (JRC) of the European Commission has launched a targeted stakeholder consultation as part of their technical work on the harmonised label. The survey aims to gather more detailed feedback on the design aspects of material-based waste sorting labels to be applied to product packaging and waste receptacles across the EU. The deadline to respond is 16 June. JRC Consultation on EU Harmonised Label for Packaging Waste
MHRA Marketing Authorisations Granted 1 to 14 May MHRA granted 4 OTC licences during 1 to 14 May 2025. MHRA Marketing Authorisations Granted 1 to 14 May
MHRA Webinar on New National Assessment Procedure for Medicines – Recording Available The recording of MHRA webinar on 'new national assessment procedure for medicines' is now available on Youtube. MHRA Webinar on New National Assessment Procedure for Medicines – Recording Available
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
