The Department of Agriculture (DA) and the Department of Health (DOH), including their respective agencies as the Bureau of Animal Industry (BAI) and the Food and Drug Administration (FDA), have agreed to allow the BAI to help the FDA assess animal vaccines and biologics.
In a memorandum of agreement (MOA) signed on Tuesday, the FDA is tasked with the issuance of a 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 to issue the BAI a license to manufacture or import as well as issue a certificate of no objection to the BAI’s importation of vaccines and biologics for evaluation and research purposes.
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 determining the safety and efficacy of both local and imported vaccines and biologics, and endorse private applications to the FDA for the issuance of certificates 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.” said 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 public health,” he added.
“This collaboration between the two agencies is testament to the renewed commitment of the government to strengthen its presence in securing the public welfare.” FDA director general Dr. Samuel A. Zacate said in his message.
“We pledge to provide the necessary resources, expertise, and support to BAI as it undertakes its responsibilities under this agreement. We pledge to uphold the highest standards of quality and safety in the veterinary sector,” he concluded.
