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
Regulatory News
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
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
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
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
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
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
FDA to study Social Media Giant “Instagram” influencers and their disclosures.
It is confirmed that 2 studies would take place mainly focusing on Instagram influencers and how their audience perceive what they say and endorse.
This is part of OPDP’s efforts to
UK, BREXIT it’s Official. What’s Next ?
UK, As the clock, strikes midnight on 31st January 2020.
The UK would have officially left the European Union and enter a transition period till 31st December 2020.
During this