Regulatory Blog

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

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

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...

The Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated guidance on " Good Clinical Practice (GCP) for...

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,...

The European Medicines Agency (EMA) has released an updated procedural guidance document on the " Appointment of CHMP, CAT, and PRAC...

The Medicines and Healthcare products Regulatory Agency (MHRA) has established comprehensive guidelines detailing the " Format and...

The European Medicines Agency (EMA) has released an addendum to its Guideline on the " Clinical Development of Vaccines to address the...

The European Medicines Agency (EMA) has released a concept paper  proposing the development of a guideline for the assessment and...

The Food and Drug Administration (FDA) of the Philippines has recently published draft guidelines to streamline the registration process...

The South African Health Products Regulatory Authority (SAHPRA) has updated its " Fee Schedule and Explanatory Notes "  to renew human...

The South African Health Products Regulatory Authority (SAHPRA) is responsible for monitoring, evaluating, and regulating the renewal of...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on " Clinical trials for medicines: manage...

The Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated guidance on pharmacovigilance requirements that...

The Medicines and Healthcare products Regulatory Agency (MHRA) has recently initiated a public consultation on draft guidance for "...

Institutional Review Boards (IRBs) play a crucial role in safeguarding the rights and welfare of human research subjects. To enhance...