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
read more...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
read more...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,
read more...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
read more...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
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
read more...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
read more...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
read more...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
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