A Preliminary Selection of Regulatory Agency Updates and Guidelines for 2025
- WSQMS
- Jan 7
- 3 min read
Updated: Jan 30
Adoption of International Scientific Guidelines in Australia
Following an extensive internal and external consultation process, 13 international scientific guidelines have been adopted.
Clinical Trials Information System (CTIS) Sponsor Handbook
The Handbook addresses key questions on CTIS and provides a compilation and references to key guidance, technical information, recommendations, training materials, and supportive documentation to facilitate the submission and assessment of CTAs and additional information during the lifecycle of a trial.
What is the Windsor Framework?
The Windsor Framework secures the long-term stability of medicines supply to Northern Ireland, ensuring that medicines will be available in the same packaging across the UK. This means that new UK-wide arrangements for medicines come into effect on 1 January 2025.
Pharmacovigilance Following Agreement of the Windsor Framework
This guidance is designed to provide information on the implementation of changes to pharmacovigilance for medicines authorized in the UK following the agreement of the Windsor Framework.
Advertising and Promotion Following Agreement of the Windsor Framework
New arrangements for human medicines come into effect from 1 January 2025, reflecting the agreement on human medicines as part of the Windsor Framework. This guidance is designed to provide information on the implementation of changes to advertising and promotion of medicines authorised in the UK from 1 January 2025.
EudraVigilance - EVWEB User Manual
This user manual is part of the official documentation prepared by the European Medicines Agency (EMA) to support the use of the EudraVigilance Web reporting tool (EVWEB).
The user manual consists of 5 chapters:
Chapter 1 presents a comprehensive overview of the EVWEB application and should be read before the other chapters. It contains basic information regarding the structure, functions and use of EVWEB, which applies to all other sections and needs to be understood before moving on to the more advanced aspects of the system.
Chapter 2 describes the creation and transmission of Safety and Acknowledgement messages (ACKs), as well as the functions available in the WEB Trader, ICSRs, Post and Workspace screens.
Chapter 3 explains the integration of MedDRA in EVWEB and how to query the system for specific MedDRA terms.
Chapter 4 provides an insight into the administration tools available in EVWEB.
Chapter 5 lists the abbreviations and acronyms, along with their descriptions, introduced in this user manual.
A Selection of Regulatory Agency Updates for 2025
Guidance on the Application of the Amended Variations Regulation as of 1 January 2025
This guidance provides instructions on the implementation of the amended Variations Regulation applicable as of 1 January 2025 that includes amendments to the Article 5 procedure, the annual update for minor variations of type IA, the procedure for grouping and super-grouping of Type IA variations, the annual update of a human influenza or human coronavirus vaccine, the mandatory (same MAH) and voluntary (different MAHs) use of the work sharing procedure, the variations to human vaccines for public health emergencies and to the Annexes.
Clinical Trials: Revised Implementing Regulations of the Human Research Act
The amended ordinances enter into force on 1 November 2024, with the exception of the provisions on transparency, which enter into force on 1 March 2025.
New Implementing Regulations Apply as of 1 November 2024
The Federal Council approved the amendments to the ordinances relating to the Human Research Act (HRA) and adopted them on 7 June 2024. The amendments strengthen the protection of persons participating in research and, where possible, improve the regulatory framework for researchers. The amended ordinances become effective on 1 November 2024, with the exception of the provisions on transparency, which will go into effect on 1 March 2025.
Changes to Declaration of Goods for the Export of Medicinal Products (including Clinical Trials) and Narcotics Made to the Federal Office for Customs and Border Security FOCBS
Federal Office for Customs and Border Security (FOCBS) introduced the new Passar goods traffic system for exports. During the transition phase, export customs declarations can be submitted either in the e-dec or Passar system. Effective 1 January 2026, only the Passar goods traffic system can be used.
ICH E11A Guideline on Pediatric Extrapolation
This guideline is intended to complement and expand on ICH E11(R1) to provide a more comprehensive framework for the use of pediatric extrapolation in optimizing pediatric drug development.
Standards of Quality and Safety for Substances of Human Origin Intended for Human Application
The European Union Parliament's Think Tank on the Regulation on substances of human origin (SoHo) published a briefing document outlining the regulation's legislative journey that led to it being published in the Official Journal of the EU in July. The SoHO regulation will take effect in July 2027.
Changes to the Guidance Document Time Limits for Authorization Applications
The new practice and the revised guidance document Time limits for authorization applications
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