The Food and Drug Administration (FDA) Philippines (formerly the Bureau of Food and Drugs) was created under the Department of Health as the regulatory and enforcement division for all food, drug, cosmetic, medical, and all related products. The FDA is responsible for ensuring the safety, purity, and quality of all products relating to food, drugs, cosmetics, medical devices, and household hazards that are available in the Philippine market. The FDA is also tasked to regulate the production, sale, and traffic of said products to protect the health and safety of the people.
One of the main functions of FDA is to issue a License to Operate to establishments as importer, distributor, wholesaler, or manufacturer of; food, drugs, cosmetics and medical devices with technical requirements in compliance to their regulations. Products are issued a Certificate of Product Registration (CPR) before it can enter the Philippine market, and must comply with the technical requirements and recommended standards of identity, purity and quality set by FDA.
The FDA is also responsible for the approval and monitoring of Clinical Trials in the Philippines. Companies wishing to introduce new and innovative products must first register with FDA, after which they will be granted a temporary CPR for use during the clinical trial; a closely monitored process which requires regular reporting.
Triple i Consulting’s Pharma division can assist your company in processing and obtaining LTOs and CPRs from FDA, as well as offer services for investors and entrepreneurs looking to do business in the Food, Cosmeceutical and Pharmaceutical Industries in the Philippines.
- Orientation to the proper processes and procedures in applying for company and product registration.
- Guidance in the preparation of all necessary documents to avoid rejection and minimize submission of incomplete documents.
- Acquisition of approved applications by monitoring the step-by-step process necessary for ratification.
With a team of pharmacists on staff to consult with FDA – one of the most stringent government offices in the Philippines – Triple i Consulting’s Pharma division can aid you in all matters related to the Philippine Food and Drug Administration.