EMA – Public Consultation on Updated Product-Specific Bioequivalence Guidance Reminder EMA – Public Consultation on Product-Specific Bioequivalence Guidance Reminder The European Medicines Agency (EMA) has published the following draft product-specific... EMA – Public Consultation on Updated Product-Specific Bioequivalence Guidance Reminder
TDMA Genotox Workshop TDMA Genotox Workshop The Titanium Dioxide Manufacturers Association (TDMA) is organising a Genotox Workshop on 13 and 14 September 2022... TDMA Genotox Workshop
EMA List of Main Therapeutic Groups in Crisis Preparedness Published EMA List of Main Therapeutic Groups in Crisis Preparedness Published The European Medicines Agency (EMA) has published the... EMA List of Main Therapeutic Groups in Crisis Preparedness Published
Digital Application Dataset Integration (DADI) Updates Digital Application Dataset Integration (DADI) Updates The European Medicines Agency (EMA) has announced multiple updates on the Digital Application Dataset... Digital Application Dataset Integration (DADI) Updates
PAGB OTC Medicinal Product Name Submission Checklist Updated PAGB OTC Medicinal Product Name Submission Checklist Updated PAGB has published an updated version of the OTC Medicinal Product Name... PAGB OTC Medicinal Product Name Submission Checklist Updated
CMDh June 2022 Meeting – Report CMDh June 2022 Meeting – Report The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published... CMDh June 2022 Meeting – Report
MHRA – Guidance for the Conversion of PLGB or PLNI licences to PL MHRA – Guidance for the Conversion of PLGB or PLNI licences to PL The MHRA has updated the... MHRA – Guidance for the Conversion of PLGB or PLNI licences to PL
EMA System Demo: DADI, PMS and Emergency Task Force EMA System Demo: DADI, PMS and Emergency Task Force On 28 June 2022 EMA is hosting a system demo on the... EMA System Demo: DADI, PMS and Emergency Task Force
IAI PIE TF Final ERA and Manufacturing Effluent Documents IAI PIE TF Final ERA and Manufacturing Effluent Documents The Inter-Association Initiative Task Force on Pharmaceuticals in the Environment (IAI... IAI PIE TF Final ERA and Manufacturing Effluent Documents
EMA Management Board – June 2022 Meeting Highlights EMA Management Board – June 2022 Meeting Highlights The European Medicines Agency (EMA) has published the highlights from its Management... EMA Management Board – June 2022 Meeting Highlights
MHRA Joins International Partnerships to Set Global Standards for Medicines and Medical Devices Regulation MHRA has Joined International Partnerships to Set Global Standards for Medicines and Medical Devices Regulation MHRA has joined three international... MHRA Joins International Partnerships to Set Global Standards for Medicines and Medical Devices Regulation
MHRA Compliance Monitor Overview and Application Process Updated MHRA Compliance Monitor Overview and Application Process Updated From April 2022, MHRA initiated a pilot scheme monitoring companies failing to... MHRA Compliance Monitor Overview and Application Process Updated