MHRA Q&A Clinic on Established Medicines Licensing MHRA Q&A Clinic on Established Medicines Licensing On 19 July, from 9.30 to 11.30 am, MHRA is hosting a Q&A... MHRA Q&A Clinic on Established Medicines Licensing
MHRA Publishes Marketing Authorisations Granted 15 June to 30 June 2023 MHRA Publishes Marketing Authorisations Granted 15 June to 30 June 2023 MHRA granted three OTC licences during 15-30 June 2023. MHRA Publishes Marketing Authorisations Granted 15 June to 30 June 2023
MHRA Sunset Clause Request for Public Health Exemption from Marketing Authorisation Invalidation Form Updated MHRA Sunset Clause Request for Public Health Exemption from Marketing Authorisation Invalidation Form Updated MHRA has updated the ‘Sunset clause:... MHRA Sunset Clause Request for Public Health Exemption from Marketing Authorisation Invalidation Form Updated
Consultation Outcome – Proposal to make Aquiette 2.5mg Tablets (Oxybutynin Hydrochloride) Available from Pharmacies Consultation Outcome – Proposal to make Aquiette 2.5mg Tablets (Oxybutynin Hydrochloride) Available from Pharmacies MHRA has published a report to... Consultation Outcome – Proposal to make Aquiette 2.5mg Tablets (Oxybutynin Hydrochloride) Available from Pharmacies
Regulation 165 Notices issued from October 2019 – May 2023 Regulation 165 Notices issued from October 2019 – May 2023 Following the previous CAP meeting, MHRA’s Borderline Team has confirmed... Regulation 165 Notices issued from October 2019 – May 2023
CMDh June 2023 Meeting – Report CMDh April 2023 Meeting – Report The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published... CMDh June 2023 Meeting – Report
NIHR and OLS – Addiction Mission: Innovation for Treatment and Recovery (AMI) Awards Launched NIHR and OLS – Addiction Mission: Innovation for Treatment and Recovery (AMI) Awards Launched The National Institute for Health and... NIHR and OLS – Addiction Mission: Innovation for Treatment and Recovery (AMI) Awards Launched
Final Tadalafil, Paracetamol and Ibuprofen Oral Use Product-Specific Bioequivalence Guidance Published Final Tadalafil, Paracetamol and Ibuprofen Oral Use Product-Specific Bioequivalence Guidance Published Following the April 2023 meeting of the EMA Committee... Final Tadalafil, Paracetamol and Ibuprofen Oral Use Product-Specific Bioequivalence Guidance Published
Real World Evidence (RWE) in Regulatory Decision Making – EMA Review and Webinar Real World Evidence (RWE) in Regulatory Decision Making – EMA Review and Webinar Real-world evidence (RWE) from studies led by... Real World Evidence (RWE) in Regulatory Decision Making – EMA Review and Webinar
MHRA Publishes Marketing Authorisations Granted 1 June to 14 June 2023 MHRA Publishes Marketing Authorisations Granted 1 June to 14 June 2023 MHRA granted one OTC licences during 1-14 June 2023. MHRA Publishes Marketing Authorisations Granted 1 June to 14 June 2023
New Platform for Pre-submission Requests and Queries New Platform for Pre-submission Requests and Queries The current platform (Jira Service Management) for Pre-submission requests and... New Platform for Pre-submission Requests and Queries
MHRA Performance Data for Assessment of Clinical Trials and Established Medicines MHRA Performance Data for Assessment of Clinical Trials and Established Medicines MHRA has published information on current performance of regulatory... MHRA Performance Data for Assessment of Clinical Trials and Established Medicines
