Regulatory Blog

Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance on (26 November 2023) the "Guidance document...

On 15 November 2023, Switzerland's Swissmedic released an updated guidance on "Formal Requirements" which serves as a resource for...

Yesterday (20 July 2023) Switzerland's Swissmedic released an updated guidance on "Harmonisation of the SwissGMP/GDP Inspection System"...

On 21 June 2023, Switzerland's Swissmedic released an updated guidance on "Information of PSURs/PBRER Submission" which describes the...

Yesterday (21 June 2023) Switzerland's Swissmedic released an updated guidance on "Authorisation Biosimilar" which specifies the...

Swissmedic recently (02 June 2023) released multiple important guidelines that have captivated the audience and generated significant...

Last week Swissmedic, the Swiss Agency for Therapeutic Products updated and released 3 Important guidances and forms. 1. Guidance on...

Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance document on (26 May 2023) the "Guidance document...

Yesterday (23 May 2023) Switzerland's Swissmedic released two updated guidances one is "Export Certificates" guidance and another one is...

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 Switzerlands Swissmedic released an updated guidance document for "Requesting Product Certificates - Certificate of a...

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...

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...