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 post-authorisation procedural advice for users of the centralised procedure (Clean Version / Tracked Version) (updated)
- Risk management plans (RMP) in post-authorisation phase: questions and answers (updated)
- Type-II variations: questions and answers (updated)
- Extensions of marketing authorisations: questions and answers (updated)
- Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (Clean Version / Tracked Version) (updated)
- Pre-authorisation guidance (updated)
- Other: Chapter 3.II: XEVPRM user guidance of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA (updated)
- Updated draft eCTD v4.0 implementation timeline for EU now available
An updated draft timeline for the implementation of eCTD v4.0 in the EU is now available on the eCTD v4.0 page here.
- A new version of the PSUR Repository NCA UI is now available
An updated version of the PSUR Repository NCA UI is now available. The new version of the PSUR Repository NCA User Interface provides a technical update only. Following the update, the PSUR Repository NCA UI has slightly different look and feel, however, there are no changes to the features and functionality of the system.
User Guidance and the Release Notes were updated and they can be found in the “User Documents” section of the page.
MHRA
- Regulating medical devices in the UK - 1 July 2023 – Guidance
- Register medical devices to place on the market 6 July 2023 - Guidance
Health Canada
- Master file application form [2023-06-26]
- Updated: Guidance on procedures and administrative requirements for master files [2023-06-26]
