The changes are with the consideration of the ICH E6(R2), key changes are:
Article 23: sponsor’s subsidies and payments provided to subjects;
Article 30: qualifications and abilities of the investigator
Article 37: responsibilities
Regulatory News
Hong Kong Issues New Guidance for Cell and Tissue Products
The guidance issued to address the quality and safety of cell and tissue products other than ATPs, the Department of Health adopts a whole-process approach to inform the industry and
read more...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 the MHRA joining the group will now be known as the
read more...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 biologicals. This is in line with the principals of international
read more...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 and, the agency’s most prominent safety warning, and requiring class-wide
read more...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
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