Regulatory Blog

Post-authorisation changes are an inevitable part of medicinal product lifecycle management, and stability data play a critical role in demonstrating that such changes do not compromise product quality, safety, or efficacy. To harmonise expectations across the EU, the European Medicines Agency has issued Revision 3 of the Guideline on stability testing for applications for variations to a marketing authorisation . Adopted in December 2025 and effective from January 2026, this

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) updated the section 3.1: 'Implementation of new guidelines' through its official guidance titled Medicines: Apply for a Variation to your Marketing Authorisation   — a key reference for MA holders operating in the UK regulatory ecosystem. A variation is any change to the terms of an existing marketing authorisation, from simple administrative updates to changes that may affect quality, safety or efficacy. T

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has modernised its processes for evaluating, approving, and maintaining marketing authorisations (MAs) under a post-Brexit regulatory framework aligned with the Windsor Framework (effective January 2025). The MHRA’s guidance documents provide a clear roadmap for each of these phases: Variations to marketing authorisations (MAs)   – covers changes after a licence is granted. National Assessment Procedure for me

On 22 September 2025 , the European Commission published new variations guidelines  in the Official Journal of the European Union. These...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published (20 December 2024) updated guidance " Variations to...

The SAHPRA released a " Communication to Industry on Quality Variations " document that addresses updates on the submission requirements...

The European Medicines Agency (EMA) has updated its page on the " Application of the Amended Variations Regulation from 1 January 2025 "...

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

The European Medicines Agency (EMA) has proposed amendments to the European Commission's "Guidelines on Variations Categories and...

Swissmedic, the Swiss Agency for Therapeutic Products, is responsible for ensuring that only high-quality, safe, and effective medical...

Yesterday (22 April 2024) the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance "Medicines: apply for a...

Yesterday (06 February 2024) Switzerland's Swissmedic released updated guidance on "Electronic exchange of ICSRs through PV Gateway", and...

Earlier today (04 July, 2023), the Drug Regulatory Authority of Pakistan released an updated draft guidance on "Guidelines for...

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

Recently (24 April 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated "General Information...

Earlier today (27 February 2023) European Medicine agency released an updated "Procedural Advice on Recommendations on unforeseen...

Recently on 10th February 2023, the European Medicines Agency (EMA) updated and released their "Validation checklist for Type II quality...

Recently EMA released an updated guidance document for the purpose of simplifying the completion of the application form process for...

The Malaysian National Pharmaceutical Regulatory Agency (NPRA) has updated its variation guideline for pharmaceutical products to be in...

On 10-May-2022 the Saudi Food & Drug Authority (SFDA) released updated guidance on "Guidelines for Variation Requirements". These...