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Swissmedic Guidances: Strengthening Regulatory Clarity for Medicinal Products

On 1 September 2025 , Swissmedic published a set of updated guidance documents that refine requirements for medicinal product...

Sharan Murugan

Sep 72 min read

South Africa: Renewal of Medicines Certificate of Registration Framework

On 26th August, 2025 the South African Health Products Regulatory Authority (SAHPRA) has introduced a structured framework for the...

Sharan Murugan

Aug 282 min read

Swissmedic Guidance: Renewal, Discontinuation, and Status Change of Medicinal Product Authorizations

The Swiss Agency for Therapeutic Products (Swissmedic) has released an updated guidance, " Renewal, Discontinuation, and Status Change of...

Sharan Murugan

Mar 32 min read

SAHPRA South Africa: Renewal of the Certificate of Registration - Fee Schedule and Explanatory Notes

The South African Health Products Regulatory Authority (SAHPRA) has updated its " Fee Schedule and Explanatory Notes " to renew human...

Sharan Murugan

Feb 192 min read

South Africa's SAHPRA: Renewal Process for Human -A Comprehensive Guide

The South African Health Products Regulatory Authority (SAHPRA) is responsible for monitoring, evaluating, and regulating the renewal of...

Sharan Murugan

Feb 122 min read

South Africa SAHPRA: eCTD Validation and Technical Screening for Renewals - Template

The South African Health Products Regulatory Authority (SAHPRA) has provided updated guidance for " ECTD Validation And Technical...

Sharan Murugan

Sep 9, 20242 min read

Saudi's SFDA: Guidance on Regulatory Framework for Drugs Approval

The Saudi Food & Drug Authority (SFDA) has released updated guidance on "Regulatory Framework for Drugs Approval". This comprehensive...

Sharan Murugan

Jun 28, 20242 min read

Swissmedic Guidance: Renewal and Discontinuation of Authorization or Change of Status (Main Authorization/Export License)

Swissmedic, the Swiss Agency for Therapeutic Products, has published comprehensive guidance "Renewal and Discontinuation of Authorization...

Sharan Murugan

Jun 15, 20242 min read

Ireland HPRA: Guide to Renewal of Marketing Authorisations –Human Medicines

Irelands Health Products Regulatory Authority (HPRA) released guidance on "Guide to Renewal of Marketing Authorisations - Human...

Sharan Murugan

Mar 29, 20242 min read

UK MHRA: Guidance on Renewing Marketing Authorisations & Implementation of Med Dev. Future Regime

Guidance on Renewing Marketing Authorisations Recently (28, July 2023) the UK's Medicines and Healthcare Products Regulatory Agency...

Sharan Murugan

Jul 30, 20231 min read

South Africa's (SAPHRA): Renewal Of Human Medicines Requirements and Process

Earlier today (09 June, 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated guideline on "Renewal...

Sharan Murugan

Jun 18, 20231 min read

SFDA's Guidance on Data Requirements for the Renewal of Marketing Authorizations Drug Products

This guideline aims to classify the requirements for submitting a renewal of marketing authorization and to provide applicants with...

Sharan Murugan

Jun 26, 20221 min read

Guidance on Renewal & Discontinuation of Authorisation on change of Status -Swiss Medic

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

Sharan Murugan

Mar 23, 20221 min read

Swissmedic Guidance on Renewals, Variations & Extensions

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

Sharan Murugan

Feb 6, 20221 min read

Saudi Arabia’s (SFDA) Guide on Regulatory Framework for Drug Registration, Variation or Renewals

Saudi Arabia’s (SFDA) updated Guide on Regulatory Framework for Drug Registration, Variation or Renewal The Drug Sector in Saudi Food &...

Sharan Murugan

Oct 19, 20211 min read