‘From 120 to 45 days’: FDA to speed up process of drug approval | ABS-CBN
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‘From 120 to 45 days’: FDA to speed up process of drug approval
‘From 120 to 45 days’: FDA to speed up process of drug approval
MANILA — The Food and Drug Administration (FDA) on Tuesday said it would quicken the approval process of generic drugs and other products in the Philippines to improve the access to medicine in the country.
MANILA — The Food and Drug Administration (FDA) on Tuesday said it would quicken the approval process of generic drugs and other products in the Philippines to improve the access to medicine in the country.
From 120 days, the approval process will be 45 days, FDA Director General Samuel Zacate said in a Palace press conference.
From 120 days, the approval process will be 45 days, FDA Director General Samuel Zacate said in a Palace press conference.
The FDA is pushing to have a “full digitalization” of process “so that the agency will have more application process on time,” he said.
The FDA is pushing to have a “full digitalization” of process “so that the agency will have more application process on time,” he said.
“It will help stakeholders to further their business interests and to strengthen drug accessibility in the country,” he said.
“It will help stakeholders to further their business interests and to strengthen drug accessibility in the country,” he said.
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Aside from shortening the number of days for processing, the FDA is also extending the validity of certain permits to 5 to 10 years, from the current 3 to 5 years, he said.
Aside from shortening the number of days for processing, the FDA is also extending the validity of certain permits to 5 to 10 years, from the current 3 to 5 years, he said.
The FDA did not “reduce the number of requirements” to speed up the process, FDA Center for Drug Regulation and Research Director Jesusa Cirunay told reporters.
The FDA did not “reduce the number of requirements” to speed up the process, FDA Center for Drug Regulation and Research Director Jesusa Cirunay told reporters.
“We do not reduce the number of requirements. We use reliance,” she said.
“We do not reduce the number of requirements. We use reliance,” she said.
“Tinitingnan natin yung papel na ginamit nila. Magre-rely kami sa isang stringent regulatory authority,” she said, noting that this is part of the Association of Southeast Asian Nations’ agreement to refer to “common technical documents” in certain fields.
“Tinitingnan natin yung papel na ginamit nila. Magre-rely kami sa isang stringent regulatory authority,” she said, noting that this is part of the Association of Southeast Asian Nations’ agreement to refer to “common technical documents” in certain fields.
President Ferdinand Marcos, Jr. has also ordered the establishment of 3 more “pharma zones” in the country to “make the drug application process easier” in the Philippines, Zacate said.
President Ferdinand Marcos, Jr. has also ordered the establishment of 3 more “pharma zones” in the country to “make the drug application process easier” in the Philippines, Zacate said.
The directive was given in a meeting in Malacañang where agriculture officials reported that some Vietnamese pharmaceutical companies selling vaccines against African Swine Fever and avian flu are interested to enter the Philippine market.
The directive was given in a meeting in Malacañang where agriculture officials reported that some Vietnamese pharmaceutical companies selling vaccines against African Swine Fever and avian flu are interested to enter the Philippine market.
In 2022, Marcos Jr. had a meeting with Indian Ambassador to the Philippines Shambhu Kumaran, where the Chief Executive reportedly said that he is “very keen" on developing the Philippines' local pharmaceutical sector with the help of India, the world’s top producer of generic drugs.
In 2022, Marcos Jr. had a meeting with Indian Ambassador to the Philippines Shambhu Kumaran, where the Chief Executive reportedly said that he is “very keen" on developing the Philippines' local pharmaceutical sector with the help of India, the world’s top producer of generic drugs.
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