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
Regulatory News
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,
Hong Kong DoH has updated the Guidance Notes for Overview of the Medical Device Administrative Control System
On 4 November 2020, the Hong Kong Department of Health has issued a new version of Guidance Notes: GN-01 Overview of the Medical Device Administrative Control System.
This document gives an
Q&A on Implementation of Chinese Pharmacopeia 2020
The Chinese Pharmacopoeia Commission has published a Q&A on the Implementation of 2020 Chinese Pharmacopeia on 30 September 2020. The Chinese Pharmacopoeia comes into effect on 30 December 2020.
https://www.pharmatomarket.com/chinese-pharmacopoeia-2020-draft-approved-by-the-chinese-pharmacopoeia-commission/
The answers
NMPA issues a Circular on the Registration of Medical Devices for Urgent Clinical Needs
This circular, dated 29 October 2020, specifies measures related to the review and approval of medical devices for urgent clinical needs. Such devices are to be used for the treatment
Malaysia MDA Launches New Version of Search System MEDICAL DEVICE AUTHORITY REGISTER for Registered Medical Devices and Licensed Establishments
On 4th November 2020, the Medical Device Authority of Malaysia issued an announcement to announce that the old PBPP Search System known as Public Search – Malaysia Medical Device Register
South Korea MFDS issues 3 Q&As relating to GMP, Official Communication Channel , Drug Approvals and other topics
South Korea Ministry of Food and Drug Safety (MFDS) has issued 3 Q&As in late-November/early-December 2020 relating to GMP, Official Communication Channel , Drug Approvals and other topics:
2020 MFDS
Australia TGA Issued a New Version of Priority Applicant Guidelines for Medical Devices (including IVDs)
TGA has issued a new version of priority applicant guidelines for medical devices (including IVDs)
The purpose of these guidelines is to assist applicants seeking a conformity assessment (priority applicant) determination