State Dining Room, Malacañan Palace
February 13, 2024
President Ferdinand R. Marcos Jr. issued several directives aimed at streamlining the country’s drug regulatory processes to lower the prices of true generic drugs and expedite the registration of common drugs as he presided over a sectoral meeting at the State Dining Room in Malacañan Palace.
During the meeting, Food and Drug Administration (FDA) Director General Dr. Samuel Zacate discussed the FDA’s standard operational procedures for pharmaceutical drug registration, ongoing challenges and strategies. He also provided proposals and recommendations to help streamline drug registrations.
Strategies include formulating policies such as providing local manufacturers and drug importers with concrete guidelines for registering their products. Notably, there will be an extension of the validity periods for the License to Operate (LTO) and the Certificate of Product Registration (CPR) from an initial three-year with five-year renewal, to a five-year initial period with a ten-year renewal. According to Dr. Zacate, these changes will not only assist stakeholders in advancing their business interests but also improve the accessibility of medical drugs in the country.
The FDA also plans to embrace digitalization by developing electronic CPR service platforms and restructuring fees and charges. These changes aim to enhance the Agency’s laboratory and testing operations, bringing them in line with the international regulatory standards.
Moreover, the meeting tackled the establishment of three (3) ‘Pharma Zones’ selected by the Philippine Economic Zone Authority (PEZA). These zones will function as a one-stop-shop for the registration of generic medicines and antibiotics, especially those already approved by stringent regulatory authorities in other countries.
To expedite the procurement of veterinary vaccines, particularly in response to the threats posed by the Avian and Swine viruses, a Joint Administrative Order (JAO) has been finalized between the FDA and the Bureau of Animal Industry (BAI) of the Department of Agriculture (DA). Under the JAO, the FDA will oversee the registration process while the BAI will handle the research aspects and importation as the procuring entity, thereby streamlining procurement processes of these vaccines.
In closing, the Chief Executive ordered the FDA to submit its proposed amendments under Administrative Order No. 67 or the ‘Revised Rules and Regulations on Registration of Pharmaceutical Products’ to further streamline its operational processes and synchronize its operations with other government agencies.
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