UK MHRA to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium
The Medicines and Healthcare products Regulatory Agency (MHRA) is the latest regulator to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium. To accommodate …
Philippines to Establish Facilitated Registration and Evaluation Pathways for Drugs, including Vaccines and Biologicals
The FDA of the Philippines has established registration pathways for the registration and evaluation of drug products, including vaccines and …
US FDA Requiring Labeling Changes for Benzodiazepines
The U.S. Food and Drug Administration made an announcement during Drug Safety Communication that the Boxed Warning will require an update …
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 …
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 …
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 …
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 …
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 …
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 …