Based on current guidelines of BE study center inspections, BE study centers that have been inspected with satisfactory inspection results will be listed in NPRA BE Study Center Compliance Program for three (3) years. Whereas, based on the current guidelines for ethics committee inspections, each ethics committee that is affiliated with DCA will be inspected periodically before the expiration of the registration period. The valid period of registration for three (3) years will be given to the ethics committee with satisfactory inspection results.
In relation to that, the Drug Control Authority (DCA) announce that the extension of the valid period of NPRA BE study center listing and the valid period of ethics committee registration with DCA from 3 years to 5 years based on criteria that listed in circular.
For further detail on Malaysia NPRA’s circular please visit the following weblink: https://npra.gov.my/index.php/en/directive-general/1527653-prosedur-dan-kriteria-pelanjutan-tempoh-sah-pusat-kajian-be-dan-jawatankuasa-etika-berdaftar-dengan-pbkd.html