Malaysia, guidance document for the pre-submission meeting.
On 13th February 2020, the Guidance Document for Pre-Submission Meeting (PSM) was unveiled.
PSM a new service provided by the Nationalized Regulatory Division of Pharmacy.
read more...Regulatory News
China, NMPA announces the publication of guidance document on medical device registration
China, NMPA announces the publication of this guidance document to further strengthen the administration and supervision on medical device registration, as well as to improve the efficiency and quality of
read more...Japan, Updated guidance on biocompatibility testing of medical devices
Japan, Updated guidance on biocompatibility testing of medical devices
Updated guidance relating to biocompatibility testing of medical devices was released by The Ministry of Health, Labour and Welfare of Japan in
read more...USA, FDA launched Guidance Snapshots
A brand pilot program has been launched in February 2020 by the US FDA on Guidance Snapshots.
These new Guidance Snapshots would be covering topics relating to modernizing drug clinical trials
read more...UK will not be acting as a leading authority for medicines during Brexit transition
UK will not be acting as a leading authority for medicines during Brexit transition.
Medicines and Healthcare products Regulatory Agency (MHRA) confirmed in a statement in February 2020 that during the
read more...USA, FDA’s launch of purple book, an online database for biologics
The US Food and Drug Administration launched the first version of the Purple Book, which is a searchable online database of biological product information.
The Purple Book will be updated weekly
read more...India’s central government to regulate all medical devices as drugs
All medical devices in India will be regulated as drugs under Drugs and Cosmetic Act of 1940 with effect from April 2020.
This regulation would focus on ensuring all medical devices
read more...Implementation of eCTD for Clinical Trial Applications in Canada
Health Canada would be accepting certain clinical trial submissions in the format of electronic common technical document (eCTD) from 19 February 2020. This comes after a successful pilot that concluded
read more...New regulations on Duties and Obligations of Establishments for Medical Devices in Malaysia
New regulations on Duties and Obligations of Establishments for Medical Devices in Malaysia
Coming into effect on the 1st of July 2020.
Duties and obligations of this regulation are categorized into 6
read more...