Philippines

DCT Feasibility Assessment Philippines The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaime...

This workbook provides an overview of the current regulatory landscape in the Philippines in relation to decentralized Clinical Trials (“DCT”). The Philippines abide by the regulations set forth by the Department of Health (DOH) and the Food and...

2.1 Name of Regulatory Authority The Department of Health (DOH) and the Food and Drug Administration (FDA) .  The FDA is an agency under the DOH that is responsible for ensuring the safety, efficacy, and quality of food, drugs, cosmeti...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.   The PNHRS and the Philippine Health Research Ethics Board (PHREB) issued the National Et...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  Details of the requirements for submission of a clinical trial application are summarized b...

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?   The Philippines complies with the ICH Good Clinical Practice (GCP). According to section 4.1 of the GCP : "The investigator(s) sh...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. Please refer to Section 2.7 of this guidebook. 6.2 Does local regulation require any separate consent for biological specimen collectio...

7.1  Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? Yes . No regulations are preventing the conduct of a decentralized clinical t...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   Personal Data gathered through research is governed by the following regulation, Revised Privacy Policy for Research...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ? Advertising and Promotion of Health Products and Medical Services Philippi...

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....

Food and Drug Administration (FDA)(n.d.) Guidelines Regulation of Clinical Trials in the Philippines ,  FDA International Council for Harmonisation (ICH)(n.d.) Integrated Addendum to ICH E6:(R1): Guideline for Good Clinical Practice , ...

 Not applicable.