The Food and Drug Administration (FDA) has announced that it will be implementing changes to streamline the registration, evaluation, and approval process for generic drugs. This move comes in response to President Ferdinand Marcos Jr.’s directive to ensure the safety and accessibility of essential drugs in the country.
Working in collaboration with the Center for Drug Regulation and Research, the FDA has introduced a Facilitated Review Pathway through an FDA Circular. This pathway offers an alternative process for those seeking to register generic drugs in the Philippines.
FDA Director-General Samuel Zacate clarified that the application process will commence once it reaches the center for evaluation. Previously, this evaluation period spanned 120 days, but it will now be shortened to 45 days. Zacate emphasized that the 45-day processing period includes amendments to the coverage of generic drugs, which now includes antibiotics, hypertensive medications, and diabetes treatments.
To expedite the registration process, applicants must secure approval from the regulatory body in their respective originating countries. If the drug has already undergone strict evaluation by the originating country prior to its application in the Philippines, the FDA will not require a lengthy re-evaluation process. Zacate further mentioned that the FDA maintains a list of Reference Drug Regulatory Agencies, which consists of strict regulatory bodies recognized by the World Health Organization.
The new memorandum outlining these changes will take effect 15 days after its publication in general circulation. This move is expected to significantly reduce the time it takes for generic drugs to reach the market, ensuring that safe and affordable medications are readily available to the public.
In addition to streamlining the registration process, the FDA remains vigilant in monitoring unregistered and counterfeit products, particularly those sold online. Zacate acknowledged the presence of numerous products with false claims being marketed online, including food supplements. To address this issue, the FDA has established a monitoring team under its Field, Regulation, and Enforcement Unit. They actively work to remove posts advertising unregistered products and urge sellers to comply with registration requirements.
It is worth noting that some sellers, whether their products are registered or not, misuse the FDA logo to entice consumers. Zacate emphasized that this practice is strictly prohibited. However, the FDA currently lacks specific legislation to impose penalties for unauthorized use of their logo. Zacate expressed the need for appropriate laws to be in place to enforce such regulations effectively.
The FDA collaborates closely with the National Bureau of Investigation (NBI) to combat the sale of unregistered and counterfeit products. However, one of the challenges they face is that these sellers often operate without a physical office, making it difficult to track and apprehend them.
To ensure that consumers make informed choices, the public is advised to consult the FDA verification portal for a comprehensive list of approved brands and products. This portal serves as a valuable resource, enabling individuals to verify the legitimacy of medications and other health products before making a purchase.
The FDA’s commitment to improving the registration process for generic drugs and monitoring the sale of unregistered and counterfeit products demonstrates their dedication to public health and safety. These efforts will contribute to a more efficient and reliable pharmaceutical industry in the Philippines, benefiting both healthcare professionals and the general public.
Source: The Manila Times
