Administrative Order No. 2020-0010 || Regulations on the Conduct of Clinical Trials for Investigational Products

This Administrative Order aims to achieve the following:

Ensure the full protection of the rights and safety of human subjects and the integrity of clinical trial data through the adoption and implementation of International Council of Harmonization-Good Clinical Practice (ICH GCP) standards;
Ensure efficient and effective process for the approval of clinical trials;
Provide standards and requirements for the regulation and importation of Investigational Products; and
Strengthen the monitoring of compliance of all organizations, institutions and entities to GCP and other related FDA regulations through regulatory inspections.