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Clinical trial regulations in the Philippines: application and protocol approval

Mar. 31, 2017

Clinical trial regulations in the Philippines are now of the utmost importance. The number of clinical trials conducted has increased substantially over the years. In 2009 alone, the Philippines saw a 30.9% increase in clinical trials conducted. Among the Association of Southeast Asian Nations (ASEAN), the Philippines now ranks third in overall clinical trial volume and 8th in annual growth, year on year, according to GlobalData.

Ethical clearance of research protocol

In 2006, the government issued the National Ethical Guidelines for Health Research to reinforce clinical trial regulations in the Philippines and make sure the regulatory phases of trials are followed. Their guidelines state seven criteria for ethical clearance of a research protocol:

  1. Science
  2. The nature and gravity of the risk to human subjects
  3. The adequacy of safeguards and protection against risk
  4. The magnitude of potential benefits or harm to individuals or community
  5. The validity of the study participants’ informed consent
  6. The ecological impact
  7. Clarification of potential conflicts of interest

All clinical trials from Phase I, Phase II, Phase III all the way through Phase IV must be approved by the Republic of Philippines Department of Health’s Food and Drug Administration (FDA).

Applying for protocol approval and timing

The application for protocol approval is on a per-phase, per-product basis. Applicants must disclose all information concerning the product they are testing. The condition intended to be addressed, the subjects, the study endpoints, and highly detailed information about the clinical trial sites must all be passed over for evaluation.

The procedure laid out by FDA regulations are as follows:

  • The applicants must submit their clinical trial proposals to the FDA.
  • The FDA passes these applications along to the Institutional Review Board/Ethical Review Board (IRB/ERB) for conduct, ethical, and technical review.
  • The IRB/ERB submits its recommendations for the approval or denial of the proposal to the FDA.
  • The FDA makes the final decision to approve or to reject proposals.

All in all, receiving the FDA's final decision is a three-to five-month process. The initial submission fee is PHP 2500 (approximately US$50). Another PHP 20,000 to 40,000 (US$400 to US$800) is charged for IRB/ERB processing fees.

SAEs, SUSARs and timelines for reporting

When Serious Adverse Events (SAE) or Suspected Unexpected Serious Adverse Reactions (SUSAR) occur, they must be reported to the Filipino FDA. Though the Filipino government does not set any official timelines for reporting, global reporting timelines set by the United States Food and Drug Administration are commonly used. Therefore, any, life-threatening SAEs or deaths must be reported to the Philippine FDA within seven days, and all other SAEs are to be reported within 15 days of the event.

The growing need for stronger clinical trial regulations in the Philippines

There is plenty of room for the growth of clinical trial regulations in the Philippines, especially a stronger regulatory environment. Clinical trial regulation guidelines will need to be more well defined and stricter. Despite the use of policies developed for the US market, there are currently no formal processes for the review and approval of clinical trials.

Nor are there formal processes for the reporting of SAE or SUSAR events. Because of a lack of enforced regulations, some investigational sites remain unsuitable for high-quality clinical trials, but are left unchecked. As the number of clinical trials increases, the regulation of clinical trials will need to be addressed in order to mitigate the risks involved.

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