Medsafe
The new article describes in detail the application process to be followed by the interested parties when applying for authorisations in the context of clinical trials.
Medsafe
The new article explains the requirements pertaining to notifications for clinical trials, as well as the Good Clinical Practice requirements.
Medsafe
The new article clarifies the regulatory requirements related to record-keeping and reporting in the context of clinical trials.
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a detailed guidance document dedicated to the process of inclusion of medical devices in the Australian Therapeutic Goods Register, the...
