Clinical trials that were authorised before 1 November 2024 (see transitional provision of Art. 72 ClinO)
For statements on the transitional provisions, please refer to the Explanatory Report "Partial revision of the implementing legislation for the Federal Act on Research involving Human Beings (HRA)" (version dated 7 June 2024).
1. Time limits for submitting the application to the second authorising authority and for enrolling the first participant (Art. 72 para. 1 ClinO)
The two-year time limit for submitting the application to the second authorising authority (Art. 23 para. 1bis and 1ter ClinO) and the two-year time limit for enrolling the first participant (Art. 23a ClinO) in clinical trials subject to ClinO only start running from 1 November 2024.
If the time limit stated in Art. 23 para. 1bis ClinO is exceeded, or if an application for an extension of the time limit stated in Art. 23 para. 1ter ClinO is rejected, the granted authorisation lapses (Art. 23 para. 1quater). In other words: If the time limit is exceeded, Swissmedic does not actively inform the sponsor or, if applicable, its representative, by letter, rather the authorisation becomes invalid with no further action.
If the first participant is not enrolled in the clinical trial within the time limit stated in Art. 23a para. 1–3 ClinO, the clinical trial is considered to be interrupted (Art 23a para. 4 ClinO). The date of inclusion of the first participant in Switzerland is defined as the date on which the first participant or the person designated as the legal representative signs the first informed consent. Swissmedic does not actively inform the authorisation holder by letter, rather the interruption becomes effective with no further action. The clinical trial may resume only when an application for an extension of the time limit in accordance with Art. 23a Abs. 3 ClinO has been approved.
2. Notification, reporting and documentation requirements (Art. 72 para. 2 ClinO)
For a period of one year after the ordinance approved on 7 June 2024 enters into force, researchers have the option of either applying the notification, reporting and documentation requirements under the old law stated in Chapter 2, Section 5 and Chapter 3, Section 4 of ClinO, or of switching to the new legislation immediately. The selection of the applicable law relates to the rules as a whole. It is not possible to apply the existing law for some requirements and the new law for others. The protocols and/or other relevant study documents to be adapted to the new law must have been adapted after one year at the latest. In other words, they should be submitted to the regulatory authorities as a change by 31 October 2025 at the latest.
3. Application for a change in category (Art. 72 para. 4 ClinO)
Article 19 ClinO can lead to previously authorised clinical trials being assigned to a lower category (B instead of C) in which less strict requirements apply compared to the existing category.
The adjustment of the category can be applied for as part of a substantial change by 31 October 2025 at the latest. Since the assessment of the admissibility of the change in category requires expertise in pharmaceutical technology, and since some of the required documents are already available at Swissmedic, the sponsor – or its representative if applicable – must submit the substantial change to Swissmedic first and to the responsible ethics committee only at a later date. A copy of the Swissmedic approval for recategorisation must be enclosed with the subsequent submission for the attention of the ethics committee.
Applications submitted to Swissmedic for assessment shortly before 1 November 2024
The provisions revised by the Federal Council on 7 June 2024 apply as of 1 November 2024, and the enforcement authorities then officially decide on clinical trials exclusively on the basis of the revised ordinances.
Applications for which the authorising official decision from Swissmedic is expected after 1 November 2024, must be based on ordinances approved by the Federal Council on 7 June 2024.
For flawless (= complete and error-free documentation, no formal and/or content-related deficiencies or ambiguities) applications submitted under the old law after 20 September 2024 (60-day assessment period) or after 6 October 2024 (30-day assessment period), Swissmedic will grant authorisation on condition that those points identified as not complying with the new law must be fulfilled before the first visit of the first patient.
In the case of deficient applications under the old law (= formal and/or content-related deficiencies or ambiguities) that cannot be decided until after 1 November 2024, Swissmedic will ask the applicants to address, in addition to the formal and content-related deficiencies, those points identified as not complying with the new law by means of a "Further Information Request".
