FDA makes it easier to export medical goods
IN line with President Ferdinand R. Marcos Jr.’s directive to strengthen the country’s healthcare system and make quality medicine accessible to the public, the Food and Drug Administration (FDA) simplified the process of exporting pharmaceutical products and Active Pharmaceutical Ingredients (APIs) through the issuance of a new administrative order.
By implementing Administrative Order (AO) No. 2024-0012 titled “Prescribing the Rules and Regulations on the Registration of Pharmaceutical Products and Active Pharmaceutical Ingredients Intended Solely for Export,” the FDA aims to ensure the availability of safe, effective and high-quality pharmaceutical products.
Section 15 of Executive Order (EO) No. 175 s. 1987, amending Republic Act (RA) No. 3720, or the Food, Drug, and Cosmetic Act,” and RA No. 9711, or “Strengthening of the Food and Drug Administration (FDA) Act of 2009,” prohibit the manufacturing, sale, importation and export of medicine and medical equipment without proper registration with the Department of Health (DOH).
Exporters of pharmaceutical products must comply with the regulations of the National Drug Regulatory Authority (NDRA) of the receiving country.
The new order seeks to ensure that products for export are not adulterated or misbranded and adhere to the regulations of foreign purchaser, and comply with the laws of the receiving country with proper labeling indicating “intended for export.”
The FDA, headed by Director General Samuel A. Zacate, has been supportive of the country’s export industry while maintaining the availability of safe and high quality medical care for all Filipinos. PCO
