Pharmaceutical Product Registration in Philippine FDA

The FDA has released Circular 2014-026 which states the new set of guidelines on the licensing of drug distributors, following AO No. 2014-0034. For initial LTO application, the new set of guidelines may seem similar to the old list however with new requirements such as " Risk Management Plan" (RMP) and "Self-Assessment Toolkit".  Please refer to the information below for the summary of requirements: Requirements for LTO Applications 1. Application Form - Integrated FDA application form, signed and by the pharmacist and owner. 2. Proof of Business Registration - DTI or SEC Registration Certificate 3. Credentials of Pharmacist - PRC ID, Cert. of Attendance for AO 56 seminar, resignation letter of pharmacist from previous employee (if applicable). 4.  The Risk Management Plan in this sense is for the establishment.   A s described in the circular, "The RMP shall contain details on how to identify, characterize, prevent or mi

The Philippine FDA was created through  Republic Act No. 3720, series of 1963, as amended by Executive Order 175, series of 1987,  otherwise known as the “Foods, Drugs, Devices and Cosmetics Act”, and has been strengthened by  Republic Act No. 9711 otherwise known as “The Food and Drug Administration Act of 200 9”. With this mandate, the Philippine FDA has become one of the most stringent government agencies in the country, covering the registration of mostly anything you see in drugstores or hospitals. The general classifications of product registered in the FDA are the following: 1. Drugs (Prescription, OTC, Household Remedy) 2. Food/Food Supplements 3. Cosmetics 4. Household Hazardous Substances 5. Medical Device With those 5 categories the FDA created the following Centers: 1. Center for Drug Regulation and Research (CDRR), FDA Alabang 2. Center for Food Regulation and Research  (CFRR), FDA Alabang 3. Center for Cosmetic Regulation and Research (CCRR), FDA Alabang