MHRA – December 2022 Licensing Time-based Performance Measures Published MHRA – December 2022 Licensing Time-based Performance Measures Published MHRA publish data on the expected time taken to process and... MHRA – December 2022 Licensing Time-based Performance Measures Published
Use of CTIS Becomes Mandatory for New Clinical Trial Applications in the EU Use of CTIS Becomes Mandatory for New Clinical Trial Applications in the EU The Clinical Trials Information System (CTIS) was... Use of CTIS Becomes Mandatory for New Clinical Trial Applications in the EU
MHRA Consultation on Proposals to Increase Statutory Fees – Government Response MHRA Consultation on Proposals to Increase Statutory Fees – Government Response The government response to consultation on proposals for changes... MHRA Consultation on Proposals to Increase Statutory Fees – Government Response
EU IDMP Implementation Guide Chapter 7 Update Released EU IDMP Implementation Guide Chapter 7 Update Released European Medicines Agency (EMA) has released the updated version of the EU... EU IDMP Implementation Guide Chapter 7 Update Released
MHRA Public Assessment Reports MHRA Public Assessment Reports MHRA has published the Public Assessment Reports (PARs) for Voltarol 140 mg Medicated Plaster (Diclofenac sodium),... MHRA Public Assessment Reports
PAGB Reclassification Workshop – Afternoon Session Added PAGB Reclassification Workshop – Afternoon Session Added PAGB’s first reclassification guidance: How to identify a reclassification candidate... PAGB Reclassification Workshop – Afternoon Session Added
MHRA Update on ECDRP MHRA Update on ECDRP MHRA has issued an announcement in relation to the reliance route for centralised procedures.The European Commission... MHRA Update on ECDRP
PAGB Notification Scheme Guidance PAGB Notification Scheme Guidance PAGB’s notification scheme guidance has now been published on PAGB’s website and can be found on... PAGB Notification Scheme Guidance
Water Framework Directive – AESGP Position Published Water Framework Directive – AESGP Position Published The European Commission (EC) is proposing stronger rules on ambient air, surface and... Water Framework Directive – AESGP Position Published
PAGB Reclassification Guidance and Workshop PAGB Reclassification Guidance and Workshop PAGB’s first reclassification guidance: How to identify a reclassification candidate and prepare... PAGB Reclassification Guidance and Workshop
MHRA Publishes Marketing Authorisations Granted in 1 – 14 January 2023 MHRA Publishes Marketing Authorisations Granted in 1 – 14 January 2023 MHRA granted two licences during 1 – 14 January... MHRA Publishes Marketing Authorisations Granted in 1 – 14 January 2023
CTIS Virtual Public Event – Readiness for Mandatory Use of the Clinical Trials Regulation from 31 January 2023 CTIS Virtual Public Event – Readiness for Mandatory Use of the Clinical Trials Regulation from 31 January 2023 The Clinical... CTIS Virtual Public Event – Readiness for Mandatory Use of the Clinical Trials Regulation from 31 January 2023