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ASF vax suppliers told: Secure FDA approval
For Vietnam-made vaccines to be commercially distributed in the country, the FDA must first issue a certificate of product registration (CPR) to suppliers following accreditation, testing and approval procedures.
MANILA – The Department of Agriculture (DA) on Tuesday urged foreign suppliers of African swine fever (ASF) vaccines to secure an approval from the Food and Drug Administration (FDA) as there are government processes they need to follow.
“Because of the talks that we have in Vietnam, we really encouraged them to apply.
And we really encouraged them to get in touch with the authorities so that we may be able to get their approvals,” DA Undersecretary Roger Navarro said in a Palace press briefing.
Navarro said the DA spoke with suppliers on the sidelines of President Ferdinand R. Marcos Jr.’s visit to Vietnam last month.
The challenge, however, remains even with the suppliers expressing intent to supply to the Philippines.
“The DA Secretary (Francisco Tiu-Laurel Jr.) has already put forward the intention to help them in this regard. There was a discussion this morning.
We hope that with the discussion this morning, it will fast-track the approvals of the supply of ASF (vaccines) in the country,” Navarro said.
For Vietnam-made vaccines to be commercially distributed in the country, the FDA must first issue a certificate of product registration (CPR) to suppliers following accreditation, testing and approval procedures.
“There are tedious processes in the government not only on vaccines, but also on permits. For example, agriculture supplies and agriculture products that go through the FDA, and somehow, the issuance of LTO (license to operate). You know, all of these things. But these are government processes that we need also to respect,” Navarro said.
In June 2023, the DA-Bureau of Animal Industry recommended the AVAC vaccine from Vietnam for the issuance of CPR following positive results of its trial in Luzon.
The testing was conducted in six areas in Luzon from March to May 2023, with a 100-percent production of antibodies and no reported side effects among four- to 10-week-old hogs.
