Regulatory Blog

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

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,...

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 Medicines and Healthcare Products Regulatory Agency (MHRA)  oversees the regulation and registration of medical devices within the...

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...

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

The U.S. Food and Drug Administration (USFDA) has released two important guidance documents addressing the risks of sepsis and...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued several guidance documents detailing the licensing,...

The International Medical Device Regulators Forum (IMDRF) has released its final guidance document (IMDRF/AIML WG/N88:2025) outlining...

The South African Health Products Regulatory Authority (SAHPRA) has issued comprehensive guidelines to streamline the reporting of...