Guidance on the Application of the Amended Variations Regulation from 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 enter into force on 1 November 2024, with the exception of the provisions on transparency, which enter into force 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
– published on 17 June 2024
On 17 March 2024, the Federal Office for Customs and Border Security (FOCBS) introduced the new Passar goods traffic system for exports. During the transition phase until 31 December 2025, 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, Step 5
– published on 3 September 2024, coming into effect on 25 January 2025
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
– announced on 10 September 2024
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 Authorisation Applications
– published on 1 September 2024
The new practice and the revised guidance document Time limits for authorisation applications come into effect on 1 September 2024.
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