The Therapeutic Goods Administration (TGA) has launched a new initiative – the Early Scientific Advice service – that enables applicants to request scientific advice on specific data before they apply
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China NMPA rolls out Drug Information Traceability System for key drug products
On October 10, 2020, NMPA made an announcement in relation for Drug Information Traceability System for key drug products (Circular No. 2020/111)
Marketing authorization holders (MAHs) take the main responsibility for
read more...Price Details to be Included for Import Licenses for Medicines in Sri Lanka
All applicants who submit applications to obtain import licenses
for medicines in Sri Lanka should submit the application along with the following price details with effect from 31st of August 2020
China Releases Technical Guidance for Using Real-World Evidence(RWE) to Support R&D and Regulatory Review of Pediatric Drugs (Interim)
The CDE has issued this guidance to assist researchers in understanding the application of real-world evidence in the R&D and clinical trials concerning pediatric drugs.
The CDE previously published “Guiding Principles
read more...Taiwan FDA has Amended the Regulations for Good Clinical Practice in Consideration of ICH E6(R2)
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
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
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