10. Roadmap of the submission process of a Clinical Trial

10.1 Clinical Trial with Investigational Medicinal Product

See Section 13 of this guidebook - Appendix 1.

10.2 Pediatric Investigation Plan (PIP)

For an application for a Marketing Authorization, a PIP is required – see Art 54. a of the Therapeutic Products Act (TPA):

“1. For each medicinal product, a pediatric investigation plan shall be drawn up with a view to its marketing authorization which sets out the requirements for the development of the medicinal product in pediatrics and which must be submitted to the Agency.

2. The Federal Council shall regulate:

1. the procedure;
2. the requirements for the pediatric investigation plan in accordance with the EU provisions.

3. It may waive the obligation to prepare a pediatric investigation plan, in particular for medicinal products for the treatment of diseases that occur only in adults. It may provide for a pediatric investigation plan assessed by a foreign authority to be taken into account.”

The revision of the TPA involved the introduction, in a form adapted to Swiss circumstances, of the system employed in the EU since the entry into force of the Pediatric Regulation of obligations and incentives designed to encourage the pharmaceutical industry to develop pediatric medicinal products. The obligation to develop and submit a pediatric investigation plan and to carry out studies for pediatric use is implemented by Swissmedic on the basis of the EU Regulation (see Regulation (EC) no. 1901/2006). Applicants can either submit to Swissmedic a PIP that has already been approved by a foreign medicines agency with comparable medicinal product control or develop their own PIP (CH-PIP). PIPs that have already been approved by a foreign medicines agency with comparable medicinal product control are accepted by Swissmedic without a separate review.

For more information, please consult the Swissmedic “Guidance document on Pediatric Investigation Plan_V2.3_23 May 2023 as well as Swissmedic Questions & Answers on the Pediatric Investigation Plan.

10.3 Clinical Study (Interventional or Observational)

Please refer to Section 10.1 above.