The Food and Drug Administration (FDA) on Monday, May 3, clarified that Remdesivir, an investigational drug currently being used in the country on patients with coronavirus disease (COVID-19), has no Certificate of Product Registration (CPR) in the Philippines.
The country’s food and drug regulatory agency said it granted Compassionate Special Permits (CSP) for Remdesivir as requested by medical specialists for the treatment of COVID-19 patients.
It said that the drug is used in adults and pediatric patients, particularly persons 12 years of age and older, for the treatment of COVID-19 requiring hospitalization.
The Department of Health (DOH) earlier said that Remdesivir can be used only in the treatment of critical and severe cases of COVID-19 in the country.
“It is clarified that a CSP is a special permit granted to physicians or hospitals to use investigational drugs or drugs which are not yet registered or in the process of registration here in the Philippines for the treatment of seriously ill patients,” the FDA said in an advisory.
It explained that a CSP can only be requested by doctors or hospitals, adding that the CSP holder takes full responsibility for the use and dispensing of the drug.
Moreover, the CSP holder must inform the patient of the investigational status of the product, and report to the FDA the results for every patient who received the product.
The FDA said the permit is given only to qualified medical specialists or institutions who are authorized to use the product to a specific number of patients, and is valid for one year.
“The public is assured that FDA recognizes the potential help of investigational products to manage COVID-19. FDA ensures that access to these types of drugs is in place in the Philippines,” the agency said.
The FDA said a CSP is not a CPR or an Emergency Use Authorization (EUA), “hence it is not an assurance of the product quality, safety, and efficacy.”
“No product granted with CSP can be marketed commercially,” it said.