The U.S. Food and Drug Administration made an announcement during Drug Safety Communication that the Boxed Warning will require an update and, the agency’s most prominent safety warning, and requiring class-wide
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UK Publishes Guidance on Regulating Medical Devices after Brexit
The UK has left the EU, and the transition period after Brexit comes to an end in 2020. Therefore UK MHRA has published on 1st September 2020, a guidance on
read more...US FDA Launches the Digital Health Center of Excellence
On 22 September 2020, The U.S. Food and Drug Administration has made announcements with regards to the launching of the Digital Health Center of Excellence within the Center for Devices and
read more...ASEAN Revises the ASEAN Variation Guidelines and the ACTD
The ASEAN ACCSQ-PPWG had endorsed intercessionally the
(i) the ASEAN Variation Guideline (AVG) Rev. 1;
(ii) ASEAN Common Technical Dossier (ACTD) Rev. 1 and
(iii) Q&A for the Stability Guideline on Vaccine
The documents
read more...Malaysia Updates Guideline for the Application of Clinical Trial Import License (CTIL) and Clinical Trial Exemption(CTX)
On August 2020, the NPRA of Malaysia has updated a document intended to guide the applicant in making Clinical Trial Import Licence (CTIL) and Clinical Trial Exemption CTX) applications to
read more...The Philippines Announces the Launch of Verification Portal for Licensed Establishments and Registered Products (29 September 2020)
The Philippines Food and Drug Administration, in its commitment to provide stakeholders with streamlined and improved government services, has developed the FDA Verification Portal System. This online portal provides comprehensive
read more...Australia Publishes Guidance for Creating Summary Page for Consumer Medicine Information (CMI)
The guidance published by the Therapeutic Goods Administration (TGA) on August 2020, gives direction about setting up the summary page for Consumer Medicine Data (CMI) documents. The document is aimed
read more...Taiwan Implements GMP/GDP for API Manufacturers
Taiwan FDA has announced that API manufacturers must 1) from 27 July 2020, API manufacturers (including those only for export) who are new, relocated, or resuming, shall apply for and
read more...Thailand Issues Notices for Medical Devices Requiring Registration
Thailand Ministry of Public Health has issued a new notification on 16 July 2020 stating the classification of medical devices, and the medical devices that manufacturers and importers are required
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