10. Roadmap of the Submission Process of a Clinical Trial

10.1 Clinical Trial with Investigational Medicinal Product

To conduct clinical trials in the Philippines that involve the recruitment of Filipinos as volunteer subjects, the FDA (Food and Drug Administration, Philippines) approval is mandatory. Clinical trials can only be initiated after receiving approvals from the Philippines FDA and Ethics Committee.

The FDA conforms to the highest ethical and technical standards of clinical research. The final approval by the FDA to conduct a trial will be based on a review by the Institutional Review Board/Ethical Review Board (IRB/ERB).

All the establishments that will conduct clinical trials in the Philippines for the purpose of product registration, must obtain a Licence-To-Operate (LTO) from the FDA as a Clinical Trial Sponsor and/or Clinical Research Organization (CRO).

This is all irrespective of the product type being investigated.

https://credevo.com/articles/2018/04/30/philippines-clinical-trial-regulatory-process/ 

For further information regarding ethics and recruitment of Filipino subjects as part of an investigational clinical study, please refer to the National Ethical Guidelines 2017.

10.2 Pediatric Investigation Plan

The FDA does not require a PIP. Please refer to the information provided in Section 9.3 of this guidebook for guidance on the use of minors in clinical studies.

10.3 Clinical Study (Interventional or Observational)

Observational trials where medication is not given to the subjects do not require approval.