MHRA Performance Data for Assessment of Clinical Trials and Established Medicines MHRA has published MHRA performance metrics for clinical trials and established medicines assessment. MHRA Performance Data for Assessment of Clinical Trials and Established Medicines
EMA Q&A Document on Article 5(3) of Regulation (EC) 726/2004 – Nitrosamine Impurities in Medicines EMA has updated the Q&A document related to nitrosamine impurities in medicinal products. EMA Q&A Document on Article 5(3) of Regulation (EC) 726/2004 – Nitrosamine Impurities in Medicines
Border Target Operating Model (BTOM) material The Cabinet Office has published useful material on BTOM. Border Target Operating Model (BTOM) material
MHRA Launches New Fees Calculator MHRA has developed a fees calculator to help companies calculate the fees they will be charged when making an initial or a variation application for a medicinal product. MHRA Launches New Fees Calculator
NHS Standard Contract 2024/25 Consultation NHSE has published the draft 2024/25 NHS Standard Contract for consultation. The consultation paper describes the main, material changes being proposed in the Contracts. NHSE welcome comments from stakeholders and Industry on the proposals. NHS Standard Contract 2024/25 Consultation
MHRA Publishes Marketing Authorisations Granted 15 December to 31 December 2023 The Medicines and Healthcare products Regulatory Agency (MHRA) has published the list of marketing authorisations granted during 15 - 31 December 2023, which includes four GSL licences. MHRA Publishes Marketing Authorisations Granted 15 December to 31 December 2023
MHRA Confirmation – Excipient Guideline Annex MHRA has confirmed that the current Excipient Guideline Annex (updated 2022), which includes reference to the 26 fragrances as allergens is applicable for medicines intended for both the GB and NI market (i.e. UK-wide). MHRA Confirmation – Excipient Guideline Annex
DHSC Review of the Risk of Modern Slavery in the NHS Supply Chain DHSC Review of the Risk of Modern Slavery in the NHS Supply Chain The Department of Health and Social Care... DHSC Review of the Risk of Modern Slavery in the NHS Supply Chain
MHRA Borderline Product Determinations Update MHRA Borderline Product Determinations Update MHRA has updated the file on final determinations by the MHRA on borderline products to... MHRA Borderline Product Determinations Update
MHRA International Recognition Procedure (IRP) Live from 1 January 2024 MHRA International Recognition Procedure (IRP) Live from 1 January 2024 From 1 January 2024, developers of new medicines can now... MHRA International Recognition Procedure (IRP) Live from 1 January 2024
MHRA Guidance – Exporting Active Substances Manufactured in Great Britain for Use in EEA and Northern Ireland Updated MHRA Guidance – Exporting Active Substances Manufactured in Great Britain for Use in EEA and Northern Ireland Updated The MHRA... MHRA Guidance – Exporting Active Substances Manufactured in Great Britain for Use in EEA and Northern Ireland Updated
Border Target Operating Model (BTOM) Webinars Defra is hosting a series of webinars on BTOM. Border Target Operating Model (BTOM) Webinars
