Ms. Joan Marie C. Alcazar, RND (Food-Drug Regulation Officer III, Licensing and Registration Division gave an update on the 34th Meeting of TMHS PWG was held last November 29-30, 2023 via video conference. The meeting, led by FDA Chairperson and Director General, Dr. Samuel A. Zacate and Vice Chairperson and Senior Consultant of Health Sciences Authority, Singapore, Mrs. Marie Tham, was well attended and all member states unite and gathered to attend this important event.
One of the major topics discussed is the “Development of an ASEAN Regulatory Framework for TMHS” where Indonesia raised clarification related to GRTK (TM concern). FDA Technical Working Group also presented the on-going draft policies for the Unified Licensing and schedule of fees, which once finalized and approved will be posted in a local newspaper. Meanwhile, the Center for Food Regulation and Research are also drafting policies on maximum limits of vitamins and minerals and working on the revision of AO 2014-0029 and the consolidated allowed nutrition claims. Claims remains a challenge to both FDA and the industry, the consolidated allowed nutrition claims will serve as a guiding principle for both FDA and the industry. The reference countries include Malaysia, Singapore, EU among others.
FDA Direction: FDA is continuously working on the digitalization process/online payment and real time posting as requested by the industry stakeholders for the applications to progress faster. As this has not been in placed yet, FDA plans to have an additional cashier to serve those who will pay physically. As for the evaluators, FDA is currently utilizing their existing and limited manpower. They also do quarterly retooling for registration.
Other FDA-related concerns: Medical claims for other FS products is a violation and FDA has an enforcement unit and inspectors are monitoring the products as part of their mandate. Companies are welcome to report to help FDA issue administrative sanctions for these violative products.
On the FS online/internet transactions, FDA’s RA 9711 does not cover online transactions. This should be an inter-agency (FDA-DTI) concern.