Regulatory Blog

Recently 30th October, 2025 the U.S. Food and Drug Administration (FDA) issued guidance titled " M13A: Bioequivalence for...

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

The South African Health Products Regulatory Authority (SAHPRA) has released a communication " Implementation of RIMS – Information on...

Recntly Switzerland's Swissmedic provided essential information on guidance " Fast-Track Authorisation Procedure " and " Temporary...

The US FDA released a draft guidance on 21st October 2024 outlining the recommendations for " Drug Interaction Information in Human...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) on 18th october, 2024 updated multiple guidances such as " Orphan...

On 18th October, 2024 the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated their guidance on the processes related...

The U.S. Food and Drug Administration (USFDA) yesterday (17 October, 2024) has issued two comprehensive Q&A guidance titled " Core...

U.S. Food and Drug Administration announced yesterday (17 October 2024) a final guidance , " Review of Drug Master Files in Advance of...

The European Medicines Agency (EMA) recently updated the guideline on "Quality and Equivalence of Locally Applied, Locally Acting...

Recently (01 October, 2024) Swissmedic released an updated guidance " Transfer of Marketing Authorisation " which provides detailed...

The Therapeutic Goods Administration (TGA) of Australia has released the latest version, v3.2, (on 13 September 2024) of the eCTD AU...

The U.S. Food and Drug Administration (USFDA) has issued comprehensive Q&A guidance titled " Electronic Systems, Electronic Records, and...

UK's Medicines and Healthcare products Regulatory Agency (MHRA) updated and released ( 1 October 2024 ) guidance " Pre-Submission Advice...

Yesterday (27 September 2024) the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on " Applying...

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) published an updated regulatory guidance on the conduct of bioequivalence...

India's CDSCO Pharmacovigilance released an updated guidance " Pharmacovigilance Guidance Document for Marketing Authorization Holders of...

Guidance: Conducting Clinical Trials With Decentralized Elements The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation...

On 16 September 2024 the European Medicines Agency (EMA) provided a detailed guide " IRIS guide for applicants - How to create and submit...

This Friday (13 Septmeber, 2024) the USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...