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...Regulatory News
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...Philippines’ executive order on medicine price cap
Philippines’ President Rodrigo Duterte officially signed the executive order which would see a cap set on selected medicines at a maximum retail price.
Under Executive Order No. 104,
“Improving Access to Healthcare through
read more...Japan, Changes to medical device regulations
An official announcement was made in regards to the adoption of a new version of the Pharmaceuticals and Medical Devices (PMD) Act.
The latest version of the PMD Act covers issues
read more...Indonesia, Directorate of Assessment providing assurance for medical devices and healthy products
Directorate of Assessment Indonesia is providing an assurance for medical devices and household health supplies distributed.
Before products enter the market for distribution all medical devices and household health supplies must
read more...