Medicines for human use EMA has included in its website a new section on Risk Minimisation Measures (RMM) including a list with all national repositories for these RMMs. T1, T2, T3 Read more " August 6, 2025
Medicines for human use EMA has published a new addendum (II) of the module VI of GVPs regarding masking of personal data in ICSRs submitted to EV. T1, T2, T3 Read more " August 6, 2025
Medicines for human use EMA has published an update of the Q&A document on fees regulation (Rev. June 2025) T1, T2, T3 Read more " August 6, 2025
Medicines for human use EMA has published a Q&A document on the webinar on SPOR and XEVMPD that took place in April 2025. T1, T2, T3 Read more " August 6, 2025
Clinical trials A new CTIS Structured data form- Notifications and results has been published. T1, T2, T3 Read more " August 6, 2025
Medicinal products for veterinary use A new version (Ver. 3) of chapter 5 (Technical Specifications) of the EU Implementation Guide (Vet EU IG) on veterinary medicines product data in the Union Product Database has been published. T1, T2, T3 Read more " August 6, 2025
Medicines for human use A new version (Rev. 3) of the document ‘CMDh Standard Operating Procedure on the Processing of PSUR Single Assessment Procedures for Nationally Authorised Products’ updating the criteria for the selection of a PSUSA LMS, has been published. T2, T3 Read more " July 9, 2025
Medicinal products for veterinary use A new version of the document ‘List of Union reference dates and frequency of submission of PSURs’ has been published (Rev. 150) – T2, T3 Read more " July 9, 2025
Medicines for human use EMA has published a new version (3) of chapter 9 of the document ‘PMS implementation of ISO standards for the IDMP in Europe’-Process for submitting exisiting data on medicinal products authorised for human use-SIAMED II & XEVMPD to PMS deltas. T1, T2, T3 Read more " July 9, 2025
Medicines for human use EMA has published a new version (V. 3) of the document ‘On-boarding of users to SPOR data services’ T1, T2, T3 Read more " July 9, 2025
Medicinal products for veterinary use EMA has published a new version of the (Rev 1.7.2523) of the document ‘Union Produc Database (UPD) release notes’ T1, T2, T3 Read more " July 9, 2025
Medicines for human use EMA has published a new version of the (Rev 7.1) of the document ‘QC of medicinal product data submitted as per the legal requirement introduced by Article 57(2) T1, T2, T3 Read more " July 9, 2025