Search
Sharan Murugan
Feb 7, 20242 min read
Swissmedic Guidance: Navigating Variations, Product Information, and Electronic ICSRs through PV Gateway
Yesterday (06 February 2024) Switzerland's Swissmedic released updated guidance on "Electronic exchange of ICSRs through PV Gateway", and...
85 views0 comments
Sharan Murugan
Nov 26, 20232 min read
Swiss Medic: Biosimilar Authorisation Guidance
Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance on (26 November 2023) the "Guidance document...
38 views0 comments
Sharan Murugan
Nov 15, 20232 min read
Switzerland's SwissMedic: Guidance on Formal Requirements
On 15 November 2023, Switzerland's Swissmedic released an updated guidance on "Formal Requirements" which serves as a resource for...
35 views0 comments
Sharan Murugan
Jul 21, 20232 min read
Switzerland's SwissMedic: Harmonisation of the SwissGMP/GDP Inspection System
Yesterday (20 July 2023) Switzerland's Swissmedic released an updated guidance on "Harmonisation of the SwissGMP/GDP Inspection System"...
45 views0 comments
Sharan Murugan
Jul 8, 20231 min read
Switzerland's SwissMedic: Guidance on Medicinal Product Name
Yesterday (07 July 2023) Switzerland's Swissmedic released an updated guidance on "Medicinal Product Name" that describes the...
35 views0 comments
Sharan Murugan
Jun 22, 20231 min read
Switzerland's SwissMedic: Guidance on Authorisation Biosimilar
Yesterday (21 June 2023) Switzerland's Swissmedic released an updated guidance on "Authorisation Biosimilar" which specifies the...
36 views0 comments
Sharan Murugan
Jun 4, 20232 min read
SwissMedic Guidance: Orphan Drug, New Active Substance & Prior Notification
Swissmedic recently (02 June 2023) released multiple important guidelines that have captivated the audience and generated significant...
36 views0 comments
Sharan Murugan
Jun 4, 20231 min read
SwissMedic Guidance on Fast-Track Authorisation, Temporary Authorisation and Variations & Extensions
Last week Swissmedic, the Swiss Agency for Therapeutic Products updated and released 3 Important guidances and forms. 1. Guidance on...
33 views0 comments
Sharan Murugan
May 28, 20232 min read
Swiss Medic Guidance: Minimising the Risk of TSE and Authorisation of Radiopharmaceuticals
Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance document on (26 May 2023) the "Guidance document...
33 views0 comments
Sharan Murugan
May 23, 20232 min read
Switzerland's Swissmedic: Med Dev Guidance on Export Certificates and Service Agreement
Yesterday (23 May 2023) Switzerland's Swissmedic released two updated guidances one is "Export Certificates" guidance and another one is...
33 views0 comments
Sharan Murugan
May 7, 20231 min read
Swiss Medic: Guidance on Transfer of Marketing Authorisation
Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance document on (3 May 2023) the "Transfer of Marketing...
46 views0 comments
Sharan Murugan
Apr 17, 20231 min read
Swiss Medic: Information sheet on Clinical Investigations with Medical Devices
Recently (13-April-2023) Switzerland's Swissmedic released an updated Information sheet document for "Information sheet on Clinical...
14 views0 comments
Sharan Murugan
Mar 17, 20231 min read
Swissmedic: eCTD v4.0 Implementation Guide published
Earlier today (17 March 2023) Switzerland's SwissMedic released published the "Implementation Guide for eCTD v4.0" and the implementation...
164 views0 comments
Sharan Murugan
Mar 13, 20231 min read
Swissmedic Guidance: Requesting Certificate of a Pharmaceutical Product (CPP)
Earlier today (13 March 2023) Switzerland's SwissMedic released an updated "Guidance document for requesting product certificates (CPP)"...
95 views0 comments
Sharan Murugan
Mar 4, 20231 min read
Swiss Medic Guidance: Product Information & Packaging for Human Medicinal Products
Recently (01 march, 2023) Swissmedic released an updated guidance document on "Product information for human medicinal products" and...
46 views0 comments
Sharan Murugan
Feb 16, 20231 min read
Swiss Medic Guidance: Document on Formal requirements
Swissmedic released an updated guidance document on "Formal requirements" yesterday (15 February 2023). By publishing this document,...
83 views0 comments
Sharan Murugan
Dec 27, 20221 min read
Swissmedic Guidance: Temporary Authorisation to Use an Unauthorised Medicinal Product
A temporary authorisation of use of an unauthorised medicinal product under restricted conditions can be granted to the sponsor of a...
41 views0 comments
Sharan Murugan
Nov 23, 20221 min read
Swissmedic: Guideline Amendments Clinical Trials & Clinical Trial Application Dossier
Earlier today (23-November-2022) Swissmedic released two updated guidelines "Guideline Amendments Clinical Trials" and "Clinical Trial...
46 views0 comments
Sharan Murugan
Sep 30, 20221 min read
Swissmedic Guidance: Medicinal Product Name HMV4
On 28 September 2022 Swissmedic updated and released their "Guidance document Medicinal product name HMV4 ". This guidance document...
55 views0 comments
Sharan Murugan
Sep 17, 20221 min read
Swissmedic Guidance: eDok Submission Update
Swissmedic on Thursday released an updated guidance document on the eDok submission which as included new templates with minor other...
45 views0 comments