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 …
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 …
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 …
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 …
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 …
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 …