Philippines Pharmaceutical Registration: An Overview

Foreign pharmaceutical companies control at least 75% of the local drug market in the Philippines. Foreign firms’ market share is divided between several countries, with U.S. producers accounting for about 10% of the market, and Switzerland, Germany, Australia, France, and the U.K. contributing similar amounts. According to the U. S. Department of Commerce, U.S. exports to the Philippines grew by 21.6% in 2000 to $8.79 billion and increased another 3.4% in the first quarter of 2001 (final 2001 figures are not yet available).

In order to market a pharmaceutical product in the Philippines, the product must first be registered to the Philippine Bureau of Food and Drugs. The pharmaceutical registration process is relatively straightforward (though as is often in the case in developing countries, having the right connections is also just as important). An application for registration should include:

  1. Letter of application and Accomplish Form No. 8
  2. Suggested Retail Price
  3. Copy of valid agreement between manufacturer and trade, distributor / importer / exporter
  4. Unit dose and batch formulation
  5. Technical specifications of finished product
  6. Certificate of analysis of active raw materials
  7. Certificate of analysis of finished product
  8. Full description of methods used
  9. Details of the assay and other test procedures for finished product including data analysis
  10. Detailed report of stability studies to justify claimed shelf life
  11. Representative sample in market or commercial presentation
  12. Unattached generic labeling materials
  13. Certificate of approval of PMS (Presidential Management Staff)
  14. Bio-availability / bio-equivalence studies (for Rifampicin products)
  15. Dissolution profile for drug product under List B (B prime)
  16. Copy of latest Certificate of Product Registration

Additional regulations apply for imported products, products in plastic containers, and for new drugs. This information is available from the Philippine Department of Health.