Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

Australia TGA: Clinical Evidence Guidelines

The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance "Clinical Evidence" on 23 November 2023,...

Swiss Medic: Biosimilar Authorisation Guidance

Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance on (26 November 2023) the "Guidance document...

USFDA Guidance Q&A: Translation of Good Laboratory Practice Study Reports

On 21 November,2023 the USFDA issued updated guidance on "Translation of Good Laboratory Practice Study Reports: Questions and Answers"...