Regulatory Blog

In March 2025, the U.S. Food and Drug Administration (FDA) released a final guidance titled “ Evaluation of Sex-Specific Data in Medical...

The Medical Device Authority (MDA) of Malaysia has released two important guidance documents, " Guide for Conformity Assessment Bodies...

The European Medicines Agency (EMA) has unveiled a comprehensive Artificial Intelligence (AI) Work Plan  to guide the integration of AI...

The U.S. Food and Drug Administration (FDA) has released the latest version (v6.0) of the Study Data Technical Conformance Guide in...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has updated the Appendix 4 Best Practice Guidance of the " Blue Guide:...

The Therapeutic Goods Administration (TGA) has released Version 3.0 of its user guide, effective from March 2025, " Completing an...

The Swiss Agency for Therapeutic Products (Swissmedic) has introduced updated guidance on " Export Certificates " effective 19 March...

The U.S. Food and Drug Administration (FDA) has announced the release of " Over-the-Counter Monograph Drug User Fee Program-Facility Fee...

The Medical Device Coordination Group (MDCG) has released the 2020-16 rev.4 guidance document, " Guidance on Classification Rules for in...

The European Medicines Agency (EMA) has released a " User Guide for Micro, Small, and Medium-Sized Enterprises (SMEs) " to help...

The Medical Device Authority (MDA) of Malaysia, under the Ministry of Health, has introduced a guidance " Importation of Medical Devices...

The South African Health Products Regulatory Authority (SAHPRA) has issued a Communication to the industry " Regulatory Information...

The European Medicines Agency (EMA) has released the updated " IRIS Guide for Applicants , " which provides detailed instructions on how...

Earlier today the Medicines and Healthcare products Regulatory Agency (MHRA) released updated guidance " Register medical devices to...

The Therapeutic Goods Administration (TGA) has released updated guidance in "Completing an application for consent to import, supply, or...

To legally sell or supply an Advanced Therapy Medicinal Product (ATMP) in the United Kingdom, you must obtain a marketing authorisation...

The Swiss Agency for Therapeutic Products (Swissmedic) has released an updated guidance, " Renewal, Discontinuation, and Status Change of...

The Swiss Agency for Therapeutic Products (Swissmedic) has released an updated guidance" Submission of Periodic Safety Update Reports...

Clinical trials are a cornerstone of medical advancement, requiring meticulous planning and adherence to regulatory guidelines. In India,...