Regulatory Blog

The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER)  has unveiled an innovative initiative—the CDER...

The United States Food and Drug Administration (USFDA) has released detailed guidance" Standardized Format for Electronic Submission of...

The United States Food and Drug Administration (USFDA) has released (05 December, 2024) the draft guidance " Expedited Program for...

The US Food and Drug Administration (USFDA)  has released two insightful reports aimed at improving its internal practices and...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has launched (4th December 2024) a groundbreaking pilot scheme "...

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has issued a Request for...

The European Medicines Agency (EMA)  has released a comprehensive document " Scientific guidelines with summary-of-product-characteristi...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued " Call to comply with Windsor Framework arrangements for...

The USFDA  continues to innovate its regulatory landscape with the release of three important guidance earlier today (27 November, 2024)...

Earlier today (20 November, 2024) the Therapeutic Goods Administration (TGA) released Version 4.0 of its Listed Medicines " Evidence...

Swissmedic, the Swiss Agency for Therapeutic Products, has introduced its updated  guidance  on " Product Information for Human Medicinal...

The UK MHRA updated its Guidance on " How Marketing Authorisation Applications referred under Article 29 are Handled " and outlines the...

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

As part of the South African Health Product Regulatory Authority’s (SAHPRA) Digitalisation Project, we launched the SAHPRA Engagement...

The Study Data Technical Conformance Guide (SDTCG) from the USFDA provides a framework to help sponsors submit standardized study data...

Recently last week (30 October, 2024) the TGA released an updated reference material about the " Good Clinical Practice (GCP) Inspection...

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...