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...Regulatory News
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...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
read more...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
read more...Indonesia, Exemption from Import Duties for Health Services Goods
The importation of health goods in Indonesia are normally subjected to a fiscal levy through customs duties and taxes in the framework of import (PDRI).
The importation of items are divided
read more...USA, Online Submissions of Orphan Designation Requests to be allowed by FDA.
USA, Online Submissions of Orphan Designation Requests to be allowed by FDA.
Upcoming in the later part of 2020, we will see them move from a paper-based process to a new
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