Regulatory Blog

The International Medical Device Regulators Forum (IMDRF) has released the fifth edition of its guidance titled “ Medical Devices:...

The South African Health Products Regulatory Authority (SAHPRA) has updated its Guideline " Section 21 Access to Unregistered Medicines "...

Swissmedic, the Swiss Agency for Therapeutic Products, has released multiple updated guidance documents in April 2025 that impact...

The European Medicines Agency (EMA) published on 31 March 2025 a draft " Reflection paper on linking to electronic Product Information...

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

The Medicines and Healthcare Products Regulatory Agency (MHRA) has introduced a " National Assessment Procedure for Medicines "  for...

Ensuring the ongoing safety and efficacy of medicinal products is a cornerstone of pharmacovigilance. In the United Kingdom, the...

The regulatory landscape for pharmaceuticals is constantly evolving, and the UK Medicines and Healthcare products Regulatory Agency...

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 Medicines and Healthcare products Regulatory Agency (MHRA) has established guidelines " Medicines: Register to manufacture, import...

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...