Under the current medical devices, regulatory framework custom-made medical devices are exempt from the requirement to be included in the Australian Register of Therapeutic Goods (ARTG). Since the introduction of
Regulatory News
Australia TGA’s Staged Transition to eCTD-only for Prescription Medicines from 1 November 2020
This transition will see Australia adopt best practice standards that are currently applied across the world. Providing benefits for both sponsors and regulators, the use of eCTD will enhance lifecycle
Singapore HSA Streamlines Stability Data Requirements for Therapeutic Product Registration
Singapore HSA has revised the Guidance on Therapeutic Product Registration in Singapore and Related Appendices. The changes will take effect for applications submitted from 31 Dec 2020.
Streamlined stability
Malaysia NPRA Issues Directive on Registration and Enforcement of Cell and Gene Therapy Products(CGTPs) in Stages
On 14 Dec 2020, Malaysia NPRA issues Directive 19 of 2020 on Registration And Enforcement Of Cell And Gene Therapy Products(CGTPS In Stages And Additional List Of Products Outside The Scope
Singapore HSA Singapore Launches New Digital Health Webpage
HSA launched this webpage in December 2020 as a one-stop portal to encourage innovation in the area of digital health by providing greater clarity on the regulatory controls and guidelines
Korea MFDS announces obligation to use E2B (R3) for electronic transmission of Individual Case Safety Reports from June 2021
On 30 November 2020, the Korean Ministry of Food and Drug Safety (MFDS) has issued a press report titled “To Report Drug Adverse Event , Use ‘International Standard Forms’!” as
Australia TGA to Allow Registration of Over-The-Counter Low Dose Cannabidiol
Australia Therapeutic Goods Administration (TGA) announced on 15 December 2020 a final decision to down-schedule certain low dose cannabidiol (CBD) preparations from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist Only Medicine).
The
China CDE Revised Procedures for Drug R&D and Technical Review Communication and Discussion with Applicant
China CDE has issued an updated version of “Administrative Measures for Drug R&D and Technical Review Communication and Discussion ” on 11 December 2020 to further standardize communication with applicants
Taiwan FDA Issues eCTD Specifications and Validation Criterion
In order to promote Taiwan’s adoption of ICH Electronic Common Technical Document (eCTD) format of , applicants will be able to use the registration platform (ExPress) to submit eCTD documents,