FDA to fast track review, approval of generic drugs

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FDA to fast track review, approval of generic drugs

Vivienne Gulla,

ABS-CBN News

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The Food and Drug Administration (FDA) will expedite the review and approval of generic drugs to 45 days from the current 120 days.

 FDA Director General Samuel Zacate signed on Thursday a circular that expands the coverage of the Facilitated Registration Pathways for Drug Products to also cover generic drug registration applications.

 Under the circular, the expedited process may only be availed for generic drugs that have been approved by at least one Reference Drug Regulatory Agency, a regulatory authority considered by the World Health Organization to apply stringent standards for quality, safety, and efficacy, in its process of regulatory review of drugs and vaccines for marketing authorization.

 “Kakapirma ko lang niyan kahapon… Mainit init pa… So ‘pag nangyari ‘yan, mas mabilis ang magiging application process nila, mas mabilis din ang pagpasok ng produkto sa atin, at mabilis na rin ang pag-access sa essential medicines natin,” Zacate said.

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 “Ang importante lang ‘yung produkto approved ng isang RDRA, strict regulatory agency. Pagpasok dito, mag-a-apply sila at bibigyan din ng documents na in-evaluate na ng kanilang originating RDRA. ‘Yun ay titingnan namin, at ‘yun ang magiging reliance namin. Hindi na namin uulitin ang proseso. Kaya siya ganoon kabilis. 45 days,” he explained.

 The FDA circular will take effect 15 days after publication in a newspaper of general circulation and upon filing of three certified copies to the University of the Philippines Law Center-Office of the National Administrative Register.

 “Kung tatanungin ninyo kailan? Siguro kasama na ‘yung 15 days, siguro mga less than a month lang ito. Pinabibilis na natin, kasi ito ang gusto ng ating mahal na Presidente para tulungan ang ating maihirap na kababayan,” Zacate said.

 The move was welcomed by two groups of doctors, but they noted that the expedited process should not compromise the evaluation on the quality and safety of generic drugs.

 “That's a good commendable move of FDA. It shortens the approval of drugs or medicines that are of low cost and yet effective. It will benefit the population of patients that are dependent on generic drugs. The expedited process should not compromise the process and steps of evaluating efficacy and quality of the generic drugs,” Philippine College of Physicians President Dr. Rontgene Solante told ABS-CBN News in a text message.

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 “The PMA definitely welcome those developments, provided the generic counterparts undergo bioavailability and bioequivalence studies prior to approval,” Philippine Medical Association President Dr. Maria Minerva Calimag, for her part, said.

 The FDA also wants to lengthen the validity of license to operate and the certificate of product registration to 6 to 12 years.

 “‘Yung mga produkto kasi, usually paulit-ulit ang documentary requirements nyan… ‘Pag humaba ang validity, parang katulad ng mga passport at driver’s license, syempre mas stable ang kanilang negosyo. Although it is still subject for inspection. Kasi syempre kailangan natin i-monitor. It’s not anytime. We are doing regular scheduled inspection, pero kapag mayroong mga emergency, we do motu proprio,” Zacate said.



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