Regulatory News

Australia TGA Publishes Guidance Document on Reclassification of Medical Devices in Direct Contact with the Heart, Central Circulatory and Central Nervous Systems

Therapeutic Goods Administration (TGA) Australia has published a guidance document on the reclassification of medical devices in direct contact with the heart, central circulatory system (CCS) and central nervous system (CNS) in August 2021.  
The guidance document aims to assist sponsors of medical devices intended to


China NMPA Implements Drug eCTD Submission

On 30 September 2021, China NMPA issued an announcement No. 119 of 2021 regarding implementation of drug eCTD submission.  

From December 29, 2021, applications for marketing authorisation of chemical drug categories 1, 5.1, and for therapeutic


Australia TGA Publishes Business Plan for 2021 and 2022

Therapeutic Goods Administration (TGA) Australia has published a document regarding its business plan and the priorities for 2021 and 2022. 
The business plan contains detailed information on the priorities, which are product regulation and safety,