Regulatory Blog

Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance document on (3 May 2023) the "Transfer of Marketing...

Recently (13-April-2023) Switzerland's Swissmedic released an updated Information sheet document for "Information sheet on Clinical...

Earlier today (17 March 2023) Switzerland's SwissMedic released published the "Implementation Guide for eCTD v4.0" and the implementation...

Earlier today (13 March 2023) Switzerland's SwissMedic released an updated "Guidance document for requesting product certificates (CPP)"...

Recently (01 march, 2023) Swissmedic released an updated guidance document on "Product information for human medicinal products" and...

Swissmedic released an updated guidance document on "Formal requirements" yesterday (15 February 2023). By publishing this document,...

A temporary authorisation of use of an unauthorised medicinal product under restricted conditions can be granted to the sponsor of a...

Earlier today (23-November-2022) Swissmedic released two updated guidelines "Guideline Amendments Clinical Trials" and "Clinical Trial...

On 28 September 2022 Swissmedic updated and released their "Guidance document Medicinal product name HMV4 ". This guidance document...

Swissmedic on Thursday released an updated guidance document on the eDok submission which as included new templates with minor other...

On 1-September, 2022 Swissmedic released the updated guidance on " Guidance document On Export Certificates". Swissmedic issues export...

Yesterday (01.08.2022) the Swiss Medic updated their "Guidance document on Authorisation procedures for Covid-19 medicinal products...

Recently on 14-July 2022, SwissMedic updated their "Packaging for human Medicinal Products" guidance. This guidance document explains how...

Guidance Document Authorisation of the human medicinal product with known Active Pharmaceutical Substance Medicinal products with known...

On 4-May-2022 the Swissmedic shared information on the technical requirements for submitting applications for clinical trials for...

This guidance document describes the rules that apply to the renewal or discontinuation of authorisation, how these rules are to be...

On 11-March-2022, SwissMedic released updated guidance on "Packaging for Human Medicinal Products". The purpose of this document is to...

On January 28, 2022 Swismedic released a list of guidances for different segments, check out the below important list of swiss medic...

On 17.09.2021, swiss medic released an updated Guidance on Authorisation of Human Medicinal Product with New Active Substance HMV4. The...

On 01.09.2021, Swissmedic updated the forms for New authorisation of human medicinal products HMV4 and Variations and authorisation...