The Chinese Pharmacopoeia Commission has announced the Approval of Chinese Pharmacopoeia Version 2020 Draft during their 11th Executive Meeting.
The meeting which was held on 9th April 2020 introduced new and
Regulatory News
Pharmacovigilance Requirements Clarified by the FDA of the Philippines
The Department of Health of Republic of Philippines has issued a Circular No. 2020-003 effective on 26 February 2020 to provide clarification on the guidelines on pharmacovigilance obligations. The circular is
Preannouncement of Name Change of AHWP to GHWP
Asian Harmonization Working Party in short (AHWP) will be changing its name to Global Harmonization Working Party (GHWP).
This change of name comes with a brand-new logo to provide better representation
Australia publishes a new guideline and FAQ on exportation of therapeutic goods
Australia TGA has published information and a new FAQ on exporting therapeutic goods from Australia.
In order to export therapeutic goods from Australia for commercial purposes, certain regulatory requirements set out
Europe proposes to delay implementation of MDR due to COVID-19
The European Commission is working on a proposal to delay the implementation of the EU 2017/745 Medical Devices Regulation (MDR / the Regulation) until 2021.
This implementation which was due to
USA, FDA finalized their guidance on 510(k) third party review program (3P510k)
This guidance provides details on how types of devices are eligible for third party review and explain how third-party review organizations are being recognized.
The 38 paged guidance provides and explains
UK, MHRA updated guidance on medicines and medical devices
The MHRA are the authorities responsible for medical device regulations throughout the United Kingdom.
In March 2020, the MHRA updated its guidance on distinguishing medicines and medical devices focusing on cases
USA, FDA finalized its guidance on its designation process and criteria for competitive generic therapies (CGTs)
USA, FDA finalized its guidance on its designation process and criteria for competitive generic therapies (CGTs).
CGTs designation was created under FDA Reauthorization Act of 2017 (FDARA) with the purpose of
Singapore adds controls to certain mercury-added medical devices under EPMA
Singapore adds certain medical devices to the control list of Mercury-Added Products under the Environmental Protection and Management Act (“EPMA”).
From 1 January 2020 onwards, the manufacturing, import and export of