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
read more...Regulatory News
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
read more...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
read more...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
read more...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,
read more...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
read more...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
read more...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
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