A House deputy speaker is urging the Department of Health (DOH) and the Food and Drug Administration (FDA) to “revert” to the national guidelines on the registration of pharmaceutical products to improve availability and affordability of locally produced life-saving medicines.
House Deputy Speaker Bernadette Herrera said the Philippines can “pause” applying the stringent Asean guidelines that have made it extremely difficult for local drug manufacturers to register their products in the country.
Herrera proposed to hold the implementation of DOH Administrative Order 2013-0021, which adopts the Asean Common Technical Dossier (ACTD) and Common Technical Requirements (ACTR) for registration of products for human use, to fast-track the process of product registration.
Herrera said a pause on the implementation of Asean guidelines is in order considering that the “Philippines is not a signatory to it.”
“I’d like to be updated on my proposal to pause the Asean guidelines because until now, I have not received a feedback on the position of FDA and DOH with regard to using the national guidelines,” the Bagong Henerasyon lawmaker said.
“Let’s pause the Asean application. Let us use our national guidelines,” she added.
Herrera issued the statement following continuation of the hearing of the House Committee on Good Government and Public Accountability last Monday on House Resolution 1711 that she and Speaker Lord Allan Velasco have filed.
The resolution called for an investigation into the guidelines and policies of the FDA and DOH for the registration, utilization, manufacture, distribution or sale of Covid-19 treatment drugs that may hamper public health service delivery to the Filipino people.
The party-list lawmaker insisted that using the national guidelines is something that would free up the process in FDA without sacrificing the efficacy and quality of the medicines that local drug companies will produce.
For her part, FDA Center for Drug Regulation and Research Director Joyce Cirunay raised that non-compliance with the ACTR would form a technical barrier to trade as it would violate the agreement among Asean member states.
Cirunay assured, however, that the FDA is expediting the process for Covid-related applications.
The Philippine Chamber of Pharmaceutical Industry Inc. and the Philippine Pharmaceutical Manufacturers Association had earlier disclosed that a total of 1,025 applications for certificate of public registration, 50 for license to operate, and 381 for automatic renewal have been pending with the FDA as of March 29.