By Ruth Abbey Gita-Carlos | Philippine News Agency
President Ferdinand R. Marcos Jr. has directed the Food and Drug Administration (FDA) to continue the streamlining of the country’s drug regulatory processes.
Marcos gave the directive in a sectoral meeting at Malacañan Palace in Manila on Tuesday morning in an effort to improve Filipinos’ access to medicines and lower drug prices, FDA director general Samuel Zacate said.
“The President has directed the Food and Drug Administration to further streamline the drug application process in the Philippines and to provide further drug accessibility for all the Filipinos, and in the future, the cheaper medicine for us,” Zacate said in a Palace press briefing.
Zacate said the FDA has already crafted several policies to ensure the proper registration of local and international drug manufacturers’ products.
He added that there is a policy extending the validity of the license to operate and the certificate of product registration from the initial three-year license and five-year renewal to an initial five-year license and 10-year renewal.
Zacate said there will also be a revision of fees to make sure that the country’s laboratory and testing capabilities will be “at par with the other international regulations.”
Pharma-zones
Marcos also broached the idea of establishing pharma-zones which will serve as one-stop shops to make the drug application process more accessible and efficient, Zacate said.
Zacate said the creation of three pharma-zones by the Philippine Economic Zone Authority will allow the entry of more foreign common drugs.
“The FDA will have a role so that pagpasok po ng isang gamot, diretso testing, diretso registration para po magkaroon po ng mabilis at malaki ang lawak ng coverage, especially those essential medicines, like for example the generic drugs and the antibiotics that has been approved by the stringent regulatory authority of the different countries,” he said.
He said the FDA is currently in talks with the Department of Information and Communications Technology and the Anti-Red Tape Authority for the establishment of the one-stop shop.
Veterinary vaccines
Marcos likewise directed the FDA and the Department of Agriculture to address the issues of work delegation to approve the necessary drugs for avian and African swine fever, Malacañang Press Briefer Daphne Oseña-Paez said.
“President Marcos stressed the urgency of veterinary vaccines as this may affect our country’s agriculture and nutrition needs,” Paez said.
Center for Drug Regulation and Research Director Jesusa Joyce Cirunay said the FDA is still waiting for the applications for veterinary vaccines but noted that there are three potential applicants.
“For now, it is still a speculation. But we know that there could be three but unfortunately, we cannot give you the details of these possible three applicants,” she said.
