FDA Simplifies Export Process for Pharma Products.

Manila: The Food and Drug Administration (FDA) has enhanced the regulatory process for pharmaceutical exports and active pharmaceutical ingredients intended for export. In a news release on Monday, the FDA said that 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' was issued following the directive of President Ferdinand R. Marcos Jr. to strengthen the health sector and expedite the distribution of medicines to the public. According to Philippines News Agency, under Section 15 of Executive Order (EO) No. 175 s. 1987, no medicine or medical equipment may be created, sold, imported, exported, or distributed if not registered following the guidelines set by the Department of Health. The EO amended the Republic Act (RA) No. 3720, or the "Food, Drug, and Cosmetic Act," and RA No. 9711, or the "Strengthening of the Food and Drug Administration (FDA) Act of 2009". P harmaceutical products designated for export must also comply with the regulations of the National Drug Regulatory Authority of the receiving country. The FDA said the rules outlined in the administrative order ensure that pharmaceutical products would not be adulterated or misbranded if they comply with the foreign purchaser's standards, follow the laws of the receiving country, and are properly labeled 'intended for export'. These provide a significant boost for current manufacturers and future investors and the position of the Philippines as a prime hub for pharmaceutical manufacturing, the FDA said.