eCTD Industry Update (5th April 2023)
EMA PRIME: priority medicines (updated) MHRA Register medical devices to place on the market – 27 March 2023 – Guidance
eCTD Industry Update (20th March 2023)
EMA: Newsletter: CTIS newsflash – 17 March 2023 eSubmissions (eCTD): 17-03-2023 Common Repository Go-Live on 20th of March 2023 (relevant for NCAs only) We are pleased to inform you that the next version of the Common Repository introducing the ‘Basic Authentication’ is going live on the 20th of March 2023 (originally planned for the 14th […]
eCTD Industry Update (13th March 2023)
EMA Newsletter: CTIS newsflash – 10 March 2023 Other: European Medicines Agency’s data protection notice for the European Union (EU) Metadata Catalogue Other: Orphan medicines figures 2000-2022 (updated) Report: Annual report on the use of the special contribution for orphan medicinal products – 2022 Report: Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 January 2023, edition 10) […]
eCTD Industry Update (21st February 2023)
EMA Regulatory and procedural guideline: Rules of procedure on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)(updated) Regulatory and procedural guideline: Questions & Answers regarding Cannabis-derived medicinal products and the scope of EU herbal monographs for herbal medicinal products within the EU medicines legislation Template or form: Day 80 assessment report – […]
eCTD Industry Update (31st January 2023)
EMA Clinical Trials Information System (CTIS): online modular training programme(updated) FDA Update on In-Person Face-to-Face Formal Meetings with FDA
eCTD Industry Update (10th January 2023)
EMA European Medicines Agency post-authorisation procedural advice for users of the Centralised Procedure Clean Version / Tracked Version (updated) European Medicines Agency Pre-authorisation guidance – Clean Version / Tracked Version (updated) Regulatory and procedural guideline: Validation checklist for Type II (non) clinical variations (updated) CMDh UPDATE – Chapter 2: Procedure for automatic validation of Mutual Recognition […]
eCTD Industry Update (21st December 2022)
EMA Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated) Human variations electronic application forms public training , Online, 10:00 – 11:30 Amsterdam time (CET), from 15/12/2022 to 15/12/2022 (updated)
eCTD Industry Update (13th December 2022)
EMA Human variations electronic application forms Q&A clinics – session 5 , Online, 14:30 – 15:00 Amsterdam time (CET), from 19/12/2022 to 19/12/2022 Regulatory and procedural guideline: EudraVigilance registration documents (updated) Human Variations electronic application forms public training , Online, 10:00 – 11:30 Amsterdam time (CET), from 15/12/2022 to 15/12/2022 Agenda: Agenda – Human variations […]
