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
Regulatory News
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
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
The Philippines Announces the Launch of Verification Portal for Licensed Establishments and Registered Products
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
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
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
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
Taiwan Publishes a Separate Standards of Review Fees for the Registration of Western Medicines
Standards or Review Fees for the Registration of Western Medicines
Considering the increase in complexity and novelty of the western medicine drug review, a relatively high technical and professional review is
New Zealand Reclassifies All Codeine-Containing Medicines as Prescription Medicines
Medsafe will gazette this change on 5 November 2020. On this date, codeine, and codeine-containing
combination products will only be able to be supplied in accordance with a prescription.
Regulations (5) and