Regulatory Blog

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Earlier today (04 July, 2023), the Drug Regulatory Authority of Pakistan released an updated draft guidance on "Guidelines for...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

The purpose of this document is to inform applicants on how to submit variations to the South African Health Products Regulatory...

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

Irelands HPRA released a few guidances in the past week Guide to New Applications and Variations to Manufacturer's Authorisations This...

Swismedic released multiple Guidance documents on 1st august, 2021 and are as follows 1. Guidance document Variations and extensions HMV4...