Guidelines

Last Updated on February 24, 2022

Regulatory compliance is essential and indispensable in order to assure the safety, quality and efficacy of therapeutic goods. Guidance documents published by the Authority are meant to explain the current interpretation or policy for better understanding of the industry and other stakeholders, as well as for our regulatory staff, and are generally intended to provide the best practices or recommended approaches to meet the regulatory requirements.

DRAP has published various guidelines on the issues related to the pharmaceutical, biological products, medical devices and alternative medicines, to address the matters of their manufacturing, quality controls, applications contents and evaluation, pharmacovigilance, import and export, market surveillance and recall and inspection system.

Please navigate to the relevant area to find the current guidance documents and related information.