On 17.09.2021, swiss medic released an updated Guidance on Authorisation of Human Medicinal Product with New Active Substance HMV4.
The definitions of biological and biotechnological substances have been revised in line with the EU definitions according to "Notice to Applicants, Volume 2A Procedures for marketing authorization, Chapter 1, Annex I, Revision 11, July 2019" (chapter 1.1.1).
The revision to be noted is that the new substance may have different properties with regard to safety and/or efficacy.
This guidance document describes the requirements relating to the documentation for the submission and authorization of human medicinal products with new active substances.
The publication of the guidance document is designed to make it clear to third parties what requirements must be fulfilled according to the practice of Swissmedic. It is also intended as a description of the requirements for having human medicinal products with new active substances authorized in Switzerland.
This guidance document applies to the authorization of human medicines with new active substances pursuant to Arts. 9, 10, and 11 TPA and for important medicinal products for rare diseases pursuant to Art. 14 para. 1 let. f TPA.
For excipients not previously authorized in Switzerland, these instructions are also valid if applicable. For radiopharmaceuticals, the specifications in Guidance document Authorisation of Radiopharmaceuticals HMV4 apply in addition.