The Philippines Pharmaceutical Registration and Approval

The Philippines FDA (previously known as BFAD) is a governmental organization that operates under the Filipino Department of Health and has the responsibility of licensing, regulating, and registering drug products in the Philippines.

The regulatory classification for drugs in the Philippines can be summarized as follows:

  • DD, Rx: refers to Dangerous Drugs identified in the Comprehensive Dangerous Drugs Act of 2002, which can only be supplied on a special Department of Health Prescription Form by a licensed doctor.
  • EDD, Rx: this pertains to medications that have any quantity of banned or regulated drugs, which can be dispensed using a regular prescription form with an S-2 license number by a licensed physician.
  • Rx: refers to prescription medicine that can only be supplied with a prescription.
  • Non-Rx: refers to non-prescription medicine that can be supplied without prescription.
  • In order for products to be marketed in the Philippines, foreign drug companies must obtain a License to Operate (LTO) from the FDA.

    The process of obtaining an LTO is outlined below:

  • Establish a business entity in the Philippines or collaborate with a local distributor
  • Collect the required documents, which include a completed application form, a site master file, evidence of business registration, a risk management plan, etc.
  • Obtain an electronic Portal account specifically for the applicant company
  • Compete the submission to the FDA for their assessment and pay the government fees
  • Obtain the LTO
  • Once the LTO is obtained, the next step is to apply for a Certificate of Product Registration (CPR) from the FDA. This indicates that the product has undergone a thorough evaluation and has been officially registered with the Philippines FDA.

    For a successful CPR application, the following documents and information must be provided:

  • Notarized application forms No. 1 and No. 8
  • A valid contract between the manufacturer and the distributor or importer
  • A valid LTO
  • Formulation of batches and individual doses using the metric system,
  • Specifications detailing the technical aspects of the raw materials,
  • A certificate of analysis issued by the manufacturer for both raw materials and final products
  • Specifications containing technical details of the final products.
  • The manufacturing process guidelines, sampling methods, quality control procedures during production, and sampling methods
  • Procedures for assay and testing, including relevant data analysis.
  • Stability study following both ASEAN and Filipino guidelines,
  • Representative samples of the packaging and labeling materials used for commercial purposes
  • The original Product Registration from the country of origin

    To learn more about how PBM can help you register your drug products in the Philippines, please contact us.