Registration process for generic drugs shortened

THE Food and Drug Administration (FDA) on Friday said it will shorten the period of registration, evaluation and approval of generic drugs, following the directive of President Ferdinand Marcos Jr. to ensure safe and accessible essential drugs.

With the help of the Center for Drug Regulation and Research, the FDA on Thursday issued a Facilitated Review Pathway through an FDA Circular, which aims to provide an alternative process to those who wish to register generic drugs in the country.

“I just want to make it clear that the application process will start once it reaches the center for evaluation. That’s when the 45 days will run. Before, that was 120 days,” FDA Director-General Samuel Zacate said in a public briefing on Friday.

He added that the 45-day processing period also includes amendments to its coverage from new drugs and vaccines only, adding generic drugs such as antibiotics, hypertensive and diabetes.

Zacate said applicants must secure approval from their respective originating countries.

If it was strictly evaluated by the originating country prior to its application to the Philippines, then FDA will not have to go through a longer process of re-evaluating the application, according to Zacate.

He added that they already have the list of countries considered Reference Drug Regulatory Agencies, a strict regulatory body determined by the World Health Organization.

The new memorandum will take effect 15 days after its publication in general circulation.

Meanwhile, Zacate said the FDA continues to strictly monitor unregistered and counterfeit products, like food supplements, being sold online.

“I admit, there are really a lot of products with false claims sold online. But we have a monitoring team on that under our Field, Regulation and Enforcement Unit. We are telling the sellers to take down posts, especially if the product is not registered,” Zacate said.

Some of the products sold online, whether registered or not are using FDA logo to entice consumers, which is not allowed, according to Zacate,

“However, we do not have a specific punishment for using the FDA logo. We all know that if there is no law, we cannot enforce it,” he added.

While it is working closely with the National Bureau of Investigation (NBI), FDA said the challenge in combating unregistered and counterfeit products is that they usually do not have a physical office.

The public is advised to check the FDA verification portal for the list of approved brands and products.