5. Investigator and Investigational Product

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) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies)."

5.2 Does local regulation require any specific documents if PI/CI is based outside the country?

The PI must be located in the Philippines.

5.3 Does local authority allow electronic ICF administration, including electronic signatures?

No, signatures for informed consent must be ‘wet’ signatures.

5.4 Does local regulation require ICF to be administered as audio/visual and do these need to be recorded?

Informed consent 

Researchers, in principle, shall obtain written informed consent from all research participants before conducting any epidemiological study. Researchers shall stipulate in their research proposals: a) how a study is explained to the research participants involved, b) how informed consent will be obtained from the participants, c) any other relevant issues concerning informed consent. 

In cases where written informed consent is impracticable, alternative methods of obtaining consent (e.g., verbal consent) shall be employed as discussed in Guidelines for Health-Related Social Research (page 108). 

Therefore, the ICF does not need to be administered as audio-visual unless written ICF is impractical.

5.5 Is there any specific information/requirement on data capture/management (e.g., privacy regulations, etc.)?

Privacy and Confidentiality of Information as defined by the National Ethical Guidelines

Researchers shall adhere to the principles of transparency, legitimate purpose, and proportionality in the collection, retention, and processing of personal information (Data Privacy Act of 2012).

Researchers must respect participants’ right to privacy. Unless required by law, the confidentiality of information shall be observed at all times. Records that link individuals to specific information shall not be released. This requirement is included in the informed consent form.

Researchers will refrain from identifying individuals or groups when the release of information about them can expose them to possible harm or social stigma unless required by law.

Where there is some likelihood or opportunity for the researcher to observe the occurrence of illegal or harmful behaviors (e.g., child abuse, substance use, self-harm, or suicide ideation), the researcher will:

1. Explicitly indicate the limits of confidentiality in the informed consent process, such as when the researcher is ethically and legally obligated to disclose the identity of the respondent to forestall imminent harm to self or others;
2. Emphasize the right of the respondent to withdraw from the study or withdraw his or her data, and to refuse to answer any question; and
3. Prepare a concrete and realistic protocol for reporting and referral if imminent harm and/or a criminal act is disclosed or discovered in the process of data collection.

Researchers shall recognize that collecting data using group methods (e.g., FGDs) has implications for the privacy and confidentiality of individuals. As it might not be possible for researchers to ensure the confidentiality of information or the anonymity of research participants, the researcher shall ensure that the nature of the study and the questions would cause minimal harm should confidentiality or anonymity be breached.

The researcher shall describe his or her data protection plan in the protocol, including the steps to be taken so that all who have access to the data and the identities of the respondents can safeguard privacy and confidentiality. For example, the researcher shall provide adequate and clear instructions to research assistants, transcribers of audio recordings, or translators of transcriptions.

http://49.231.15.21/deptw13/upload/files/hercF256312041721022781.pdf

5.6 If a clinical study involves the study product as OTC and this is provided via pharmacy/amazon, etc., are there any specific regulations for IP management that need to be followed?

No, there is no specific guidance around the delivery of IMP.

5.7 For a marketed study product/OTC, can a participant be compensated after confirmation of the purchased study product, or upfront prior to product acquisition? Does compensation in any way impact how the study is viewed (i.e., RWE vs. Interventional Study)?

No. There is no specific guidance around the payment for IMP.

5.8 Is it permitted to pay participant stipends (i.e., is it permitted to pay the patients for their participation in the clinical trial)? If so, what is the average range?

The payment of reasonable expenses is allowed. Many clinical trials in the Philippines offer $50-$100 vouchers and incentives.

5.9 Specific labeling requirements for clinical study product

The requirements for labeling of IMP are described in Administrative Order No. 2020-0010. The guidance states that:

"The label of an investigational product shall not bear any statement that is false or misleading in any particular and shall not represent that the investigational product is safe or effective for the purposes for which it is being investigated."

Detailed guidance is provided in Appendix C8 of the guidance at the link above. 

5.10 What documents need to be submitted (including relevant fee if any), and to whom, if a permit is needed for an investigational/study product being shipped from outside the country? Are there any specific requirements for biologics?

As a rule, only drugs that are covered by a Certificate of Product Registration (CPR) from the FDA can be imported into and distributed in the Philippines. By way of exception, for purposes of clinical trial use, medicines not yet registered with the FDA can be imported by obtaining an import permit for investigational drug products ("Import Permit") with the FDA. In addition to unregistered drug products for clinical trials, the Import Permit allows the inclusion of ancillary supplies, such as laboratory kits, reagents, and other materials to be used for the clinical trial concerned.

To receive this import permit, the applicant must comply with the following:

1. The applicant company shall submit the clinical trial application to the FDA 166 through email at clinicalresearch@fda.gov.ph.
2. The Center for Drug Regulation and Research (CDRR) shall pre-assess the application by determining the completeness of the dossier submission and if it satisfies the requirements for the abridged pathway.  
3. The applicant shall submit the documentary requirements cited in AO No. 2020-0010. In addition, the following documents should be submitted: 
   1. A formal letter/written request from the applicant notifying the FDA of its intent to avail of the abridged review, identifying the RDRA.
   2. Copy of the clinical trial approval from the identified RDRA.
   3. A declaration letter (Annex B) duly signed by the Sponsor or the authorized CRO stating the requirements under Section V. A.5.b and A.5.c. of this Circular.
4. The abridged evaluation process and regulatory decisions for clinical trials 181 shall be as follows:
   1. Sponsor/CRO shall secure authorization from the FDA for the conduct of clinical trials in the Philippines through the process of approval within 20 working days as illustrated in Annex C. 
   2. An application is deemed filed upon submission of the documentary 186 requirements including payment of fees. 
   3. Upon receipt of the application, the FDA shall review the completeness and veracity of the documentary requirements and shall assign a Regulatory Reviewer for the clinical trial application within three (3) working days. 
   4. An application shall be processed by the FDA Regulatory Reviewers within ten (10) working days upon receipt of the application and payment of the required fee directly charged to the applicant. If there is a need for any clarification on the application, an electronic notification shall be sent to the applicant; the processing time or clock stops in this step. The applicant is expected to respond to the query/ies within five (5) working days from sending of e-mail correspondence. If a response is not received from the applicant within the required period, the application shall be disapproved. 
   5. The FDA shall issue a decision within seven (7) working days upon receipt of the recommendation from the Regulatory Reviewers.
5. The Import License (IL) and the Clinical Trial Approval (CTA) shall both be issued. The IL shall have a validity of three (3) years and can be used repeatedly within the validity period.

Under Circular 07, the following persons may apply for the Import Permit: 

1. Principal investigator 
2. An authorized representative of the study sponsor (a registered pharmaceutical company with a permanent address in the Philippines) 
3. A CRO with a permanent Philippine address representing the sponsor through a letter of authorization

To obtain the Import Permit, the application must be supported by the FDA document attesting to the approval of the clinical trials to proceed based on compliance with ethical and technical requirements ascertained by the ERC.

https://members.wto.org/crnattachments/2022/TBT/PHL/22_3815_03_e.pdf 

5.11 What is the turn-around time to get an import permit?

Typically, approval of an import permit takes 30 days.

5.12 Does local authority allow the destruction of clinical supplies at an off-site location (e.g. third-party vendor in or outside the country) after study completion? Are certificates of destruction required?

There is no specific guidance around the destruction of IMP.