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Friday, September 20, 2024

FDA grants BAI authority to make, import animal vaccines

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The Department of Agriculture (DA) and the Department of Health (DOH) signed a memorandum of agreement (MOA) allowing the Bureau of Animal Industry (BAI) to assist the Food and Drug Administration (FDA) in the evaluation of animal vaccines and biologics.

“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,” said Agriculture Secretary Francisco Tiu Laurel Jr. at the signing of the agreement.

Under the MOA, the FDA will continue to issue licenses to operate (LTO) for manufacturers, traders and distributors of veterinary drugs and products, including vaccines and biologics. The FDA will also grant BAI the authority to manufacture or import vaccines and biologics for evaluation and research purposes.

The DA said the MOA would strengthen the fight against transboundary animal diseases like African Swine Fever and Highly Pathogenic Avian Influenza. The agreement emphasized the importance of robust regulations for animal health, impacting food security and public health.

Tiu-Laurel said the DA is committed to ensuring the safety and efficacy of veterinary drugs and products for animal well-being and public health protection.

“This collaboration strengthens the government’s commitment to public welfare. We will provide resources and expertise to BAI and uphold the highest standards of quality and safety in the veterinary sector,” said FDA director-general Samuel Zacate.

The MOA tasks BAI with evaluating the safety and efficacy of both local and imported vaccines and biologics. The animal bureau will also endorse private applications for product registration and provide evaluation reports to the FDA.

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