Regulatory Blog

The International Council for Harmonisation (ICH) continues to advance global standards in drug development and clinical practices with...

The U.S. Food and Drug Administration (FDA) recently released (26 December 2024) draft guidance titled “ Protocol Deviations for Clinical...

The U.S. Food and Drug Administration (FDA) has updated and released its " Global Unique Device Identification Database (GUDID) "  final...

The European Medicines Agency (EMA) has issued comprehensive guidance " European Medicines Agency Pre-Authorisation Procedural Advice for...

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the " Licensing of Biosimilar Products " in...

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

The South African Health Products Regulatory Authority (SAHPRA) has released two crucial guidelines to streamline adverse event reporting...

The Australian Regulatory Guidelines for Medical Devices (ARGMD) , issued by the Therapeutic Goods Administration (TGA), provide a...

The U.S. Food and Drug Administration (FDA) has released a guidance " Technical Specifications for Submitting Clinical Trial Data Sets...

The Medicines and Healthcare Products Regulatory Agency (MHRA)  has published updated guidance " Applying for a Licence to Market a...

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The United States Food and Drug Administration (USFDA) has released (05 December, 2024) the draft guidance " Expedited Program for...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 issued its final guidance on " Marketing Submission Recommendations for a Predetermined...

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

The Medicines and Healthcare products Regulatory Agency (MHRA) has published detailed guidance " Clinical Investigation s " on...

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