Gov't overhauls veterinary medicine approvals to protect livestock
The Bureau of Animal Industry (BAI) has now assumed control over the registration of animal health products from the Food and Drug Administration (FDA), a move expected to speed up vaccine development.
The Department of Agriculture (DA) issued Department Circular (DC) No. 33 to officially transfer regulatory functions over veterinary drugs, products, and biologics from the FDA to the BAI.
This builds on a joint advisory between the DA and the FDA issued in November last year, which streamlined guidelines on animal health products to strengthen government oversight, as embodied under the Animal Industry Development and Competitiveness Act (AIDCA).
Under the circular, the BAI is authorized to issue a certificate of veterinary product registration (CVPR) to approve animal health products prior to their manufacture, importation, distribution, or sale in the Philippines.
Sought for comment, Agriculture Assistant Secretary Arnel de Mesa said granting this power to the BAI will help accelerate the processing of animal health products seeking to enter the domestic market.
He said this is particularly relevant in the registration of vaccines, which is crucial to strengthening the government’s measures against animal diseases that threaten domestic livestock and poultry production.
All CPVR holders are required to establish and maintain a monitoring system to report potential defects and adverse effects of the product, providing another crucial safeguard.
A CVPR is valid for two years upon initial issuance and an additional five years upon renewal, subject to compliance, according to the DA.
Under DC No. 33, the BAI also assumes responsibility for issuing licenses to operate (LTOs), which are required for establishments that manufacture, trade, or sell animal health products.
“Only establishments with adequate facilities, qualified personnel, and systems ensuring the safety, efficacy, and quality of veterinary drugs, products, and biologics shall be granted an LTO,” the DA said.
Further, the BAI will also oversee the listing of other animal health products intended for food animals, companion animals, laboratory animals, aquatic animals, and exotic animals.
This covers non-medicated animal grooming aids, oral hygiene products, and other animal products or devices categorized as low-risk products.
All permits issued by the FDA prior to the policy change will remain valid until they expire, unless violations are found.
In line with the AIDCA, the FDA also granted the National Dairy Authority (NDA) regulatory control over the dairy industry last year, including the testing and accreditation of local dairy activities.