eCTD Industry Update (18th September 2023)
EMA 15/09/2023 Regulatory and procedural guideline: Compilation of Union procedures on inspections and exchange of information (updated) 15/09/2023 Newsletter: CTIS newsflash – 15 September 2023 14/09/2023 Regulatory and procedural guideline: Guidance on paediatric submissions (updated) 14/09/2023 Webinar on Regulatory Procedure Management for Product Lifecycle Management 1st roll-out on IRIS , Online, from 15/09/2023 to 15/09/2023 […]
eCTD Industry Update (13th September 2023)
EMA 08/09/2023 – Innovation in medicines (updated) 07/09/2023 – Template or form: Application form for European Medicines Agency certificates of medicinal products (updated) 05/09/2023 – Other: Frequently asked questions about parallel distribution (updated) 04/09/2023 – Frequently asked questions about parallel distribution (updated) 04/09/2023 – Newsletter: CTIS newsflash – 1 September 2023
eCTD Industry Update (4th September 2023)
EMA 30/08/2023 How to prepare and review a summary of product characteristics (updated) 29/08/2023 Risk management plans (updated) Template: Declaration for the risk management plan (RMP) publication (updated)
eCTD Industry Update (21st August 2023)
EMA Newsletter: CTIS newsflash – 18 August 2023 Webinar on Regulatory Procedure Management for Product Lifecycle Management 1st roll-out on IRIS , Online, from 15/09/2023 to 15/09/2023
eCTD Industry Update (7th August 2023)
EMA 04/08/2023 Newsletter: CTIS newsflash – 4 August 2023 eSubmissions (eCTD) 01-08-2023 Updated PLM Portal eAF Guide to Registration is now available Please find an updated version of the PLM Portal eAF Guide to Registration here. MHRA Register medical devices to place on the market CE marking recognition for medical devices and in vitro diagnostics […]
eCTD Industry Update (1st August 2023)
EMA 27/07/2023 PRIME: priority medicines(updated) 26/07/2023 Clinical Trials Information System (CTIS) bitesize talk: Part I-only applications and Part II requirements in CTIS, Online, 15:30 – 17:00 Amsterdam time (CEST), from 30/08/2023 to 30/08/2023 19/07/2023 Big data(updated) 19/07/2023 The use of Artificial Intelligence (AI) in the medicinal product lifecycle 19/07/2023 Multidisciplinary: artificial intelligence (AI) 19/07/2023 News […]
eCTD Industry Update (17th July 2023)
EMA 13/07/2023 Clinical Trials Information System (CTIS): Information day , Online, 13:30- 17:30 Amsterdam time (CET), from 17/10/2023 to 17/10/2023 (updated) 12/07/2023 Other: Guide to information on human medicines evaluated by European Medicines Agency: what the Agency publishes and when (updated) 12/07/2023 Other: Annex I – Guidance document on how to approach the protection of […]
eCTD Industry Update (13th July 2023)
EMA PRIME: priority medicines (updated) Other: European Medicines Agency guidance for applicants seeking access to PRIME scheme (updated) Referrals document: Nitrosamines EMEA-H-A5(3)-1490 – Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products (updated) Regulatory and procedural guideline: European Medicines Agency […]
eCTD Industry Update (4th July 2023)
EMA Regulatory and procedural guideline:Procedural advice on publication of information on withdrawals of applications related to the marketing authorisation of human medicinal products (updated) eSubmissions (eCTD) PSUR Repository (NCA UI) Go-live 3rd July 2023 We are pleased to inform you that an updated version of the PSUR Repository NCA UI is going live on the 3rd of July 2023. […]
eCTD Industry Update (19th June 2023)
EMA Clinical Trials Information System (CTIS): Information day , Online, 13:30- 17:30 Amsterdam time (CET), from 17/10/2023 to 17/10/2023 EudraVigilance and Signal Management information day , European Medicines Agency, Amsterdam, the Netherlands, 09:30-17:00 CET, from 21/11/2023 to 21/11/2023 European Medicines Agency practical guidance on the application form for centralised type IA and IB variations (updated) eSubmissions (eCTD) Updated […]
