Question & AnswerQ&A (BFAD BUREAU CIRCULAR NO. 14, S. 2005)
Gene therapy is an experimental treatment that involves introducing genetic material (DNA or RNA) into a person's cells to treat or prevent disease.
The primary function of BFAD is to ensure that drugs, medical devices, and biological products, including gene therapy products, are safe and effective before they are prescribed and used.
BFAD regulates all gene therapy products and studies, ensuring they comply with standards of safety, efficacy, purity, and potency.
Requirements include License to Operate (for local manufacturers), Certificate of Current Good Manufacturing Process, manufacturing summary, product details, laboratory safety tests, animal study protocols and results, clinical trial permits, study protocol, and informed consent documents.
It must include study procedures, patient inclusion/exclusion criteria, administration details, expected benefits, efficacy determinations, potential risks, patient protection measures, and additional supporting data.
Trials must adhere to the Declaration of Helsinki, Good Clinical Practice (GCP, 1997), and applicable Philippine laws and regulations.
Approval must be secured from the Hospital Institutional Ethics Review Board consisting of scientific, legal, medical, religious, and consumer advisors.
They review IND applications to determine the appropriateness, effectiveness, and safety of the gene therapy while ensuring protection of human subjects.
The panel includes microbiologists, molecular biologists, pharmacologists, toxicologists, and immunologists.
Informed consent must be obtained, informing participants of potential risks and benefits involved in the study.