This week’s top three global regulatory updates include:
1. Egypt: New guidelines for applying national good clinical practice regulations have been released, detailing the submission process for interventional medical research involving human participants, including studies on pharmaceuticals, medical devices, and herbal medicines.
2. Iraq: The Ministry of Health has set a deadline of January 1, 2025, for the registration of medical devices and in vitro diagnostic device manufacturing sites. After this date, imports will not be approved without site registration.
3. Canada: The Therapeutic Products Classification Committee has clarified the classification of combination products, outlining which are considered drugs, which are devices, and those that must comply with both drug and medical device regulations.
Stay tuned for more updates!
