FDA calls upon the assistance of BAI to undertake veterinary vaccine testing

The Department of Agriculture (DA) and the Department of Health (DOH), including their respective agencies, the Bureau of Animal Industry (BAI) and the Food and Drug Administration (FDA), have agreed to allow BAI to assist the FDA in conducting evaluations of animal vaccines and biologics.

In a Memorandum of Agreement (MOA) among the agencies that was signed on June 4, 2024, the FDA will be tasked to issue License to Operate (LTO) to manufacturers, traders and distributors, and retailers of veterinary drugs and products, including vaccines and biologics.

The FDA is also expected, based on the MOA, to issue an LTO to BAI for manufacturing or importation and the issuance of certificate of no objection for BAI’s importation of vaccines and biologics for its evaluation and research.

Among the animal diseases affecting the livestock and poultry industry are Highly Pathogenic Avian Influenza (HPAI) and African Swine Fever (ASF)—both highly contagious viral diseases that have grossly undermined the local poultry and hog industries. The hog and poultry industries are strong pillars of the agriculture sector in generating investments and jobs as well as vital to the DA’s goal of ensuring food security.

For its part, the BAI is expected to conduct evaluations to determine the safety and efficacy of both local and imported vaccines and biologics, and endorse private applications to the FDA for the issuance of certificate of product registration to local and imported veterinary products and provide the FDA with evaluation reports.

“This MOA will significantly strengthen our fight against transboundary animal diseases such as African Swine Fever and Highly Pathogenic Avian Influenza. By enhancing our regulatory framework and fostering greater cooperation among key agencies, we can better safeguard the animal industry, secure the livelihoods of our farmers, and mitigate the impact on our economy.” Agriculture Secretary Francisco P. Tiu Laurel Jr. at the signing of the MOA.

“At the DA, we are fully committed to the agreement as a means to ensure the safety and efficacy of veterinary drugs and products, not only for the well-being of our animals but also for the protection of