Philippines: Product Registration for Pharmaceuticals

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I. Introduction to the Philippines

The Philippines was hit hard by the Asian crisis. In 1998, the Filipino economy deteriorated — growth fell to a negative 0.5% from 5.0% in 1997. The Philippines government has announced that its 1999 economic growth was 3.1%, above the IMF’s estimate of 2.5%. The government has promised to continue its economic reforms by improving infrastructure, overhauling the tax system and increasing deregulation and the privatization of the economy.

II. Pharmaceutical Market

The Filipino pharmaceutical market in 1999 was estimated to be about 36.83 billion pesos (about delete extra space $900 million). After Japan, Korea and Taiwan, the Filipino pharmaceutical market is the fourth largest in Asia. The market grew about 5.0% in 1999. Pharmaceutical products (both ethical and OTC) are primarily distributed to customers via pharmacies (78%), hospitals (13%) and other channels (9%). Mercury Drug Stores is the largest pharmaceutical chain in the Philippines with about half of the overall pharmacy business. Major areas where therapeutic products are used include anti-infective, respiratory, cardiovascular and the central nervous system. Leading ethical products in the market include Ventolin (Glaxo), Augmentin (Smith Kline), Ponstan (Warner Lambert), Plendl (Astra) and Propan Iron (Rorer). While the Philippines is a large geographic area (about the size as Italy) made up of many islands (20 islands account for 92% of the landmass), the Metro Manila area accounts for about 50% of the pharmaceutical market, the Luzon area about 25% and the remainder split between the Visayas and Mindanao regions.

III. Pharmaceutical Healthcare Association of the Philippines (PHAP)

The PHAP is an association composed of local and multinational pharmaceutical manufacturers, traders, distributors and retailers. Affiliated with PHAP are six professional organizations within the healthcare industry such as the Marketing Executives in the Pharmaceutical Industry (MEPI), Pharmaceutical Executives of the Philippines (PEP), Philippine Pharmaceutical Manufacturers Association (PPMA), Philippine Association of Pharmacists in the Pharmaceutical Industry (PAPPI), Association of Pharmaceutical Trainers (APT) and the Philippine College of Pharmaceutical Medicine which is affiliated as a society of the Philippine Medical Association. Mr. Leo P. Wassmer, Jr. is the Executive Vice President and Chief Executive Officer of PHAP, a position he assumed after his retirement as General Manager of Eli-Lilly ( Philippines), Inc. in 1990. PHAP can be contacted at the following address:

Unit 502, One Corporate Plaza, 845 Pasay Road, Makati City, Philippines Tel. # 815-03-25, Fax # 819-27-02, E-Mail; phap7346@info.com.ph

IV. Philippines Product Registration for Pharmaceuticals

While rules and regulations with respect to most things in the Philippines are quite “fluid”, the pharmaceutical product registration environment is no different. The checklists below should be helpful in navigating the process.

 

CHECKLIST OF REQUIREMENTS INITIAL AND CONDITIONAL REGISTRATION

REQUIREMENT
# of copies
1
 Letter of application
2
2
 Copy of valid certificate of brand name clearance.
1
3
 Copy of valid agreement between manufacturer and trader/distributor/importer/exporter
1
4
 Unit dose and batch formulation.
2
5
 Technical specifications of all raw materials
2
6
 Certificate of analysis of active raw material(s)
2
7
 Certificate of analysis of finished product.
2
8
 Technical specifications of finished product.
2
9
 Full description of the methods used, the facilities and controls in the manufacture, processing and packaging of the product.
2
10
 Details of the essay and other test procedures for product including data analysis.
2
11
 Detailed report of stability studies to justify claimed shelf life.
2
12
 Sufficient samples in market or commercial presentation for laboratory analysis (as per M.C.20 s. 1994) and representative sample for PSD.
2
13
 Unattached generic labeling materials; label, box, insert, blister/strip foil.
2
14
 For imported drug product: a) Certificate of free sale from country of origin.
1
b) Government certificate attesting to the status of the manufacturer as to competency, reliability of personnel and facilities.
1
a & b) Authenticated by territorial Philippine consulate.
15
 For drug product in plastic container
15.1
 Studies done on the plastic to substantiate claim that product is safe to use:a) Components of the plastic used. b) Chemical tests. c) Physical tests d) Biological tests (cell toxicity, tissue implantation, etc.d) for parental and ophthalmic preparations. .
2
15.2
 Methodology on how different tests were conducted and include limits (results) of each test.
2
15.3
 Empty plastic containers and closures.
2
16
 For New Drug Application (if applicable):
a) Pre-clinical studies.
1
b) Clinical studies (phases I, II and III).
1
c) Protocol for monitored release.
1
17
 Certificate of approval of PMS (if applicable).
2
18
 Bioavailability/bioequivalence studies (for products under List B, as per B.C. #01 s. 1997).
19
 Requirements for sterile products (as per B.C.#?).

 

CHECKLIST OF REQUIREMENTS FOR REGISTRATION OF FOOD PRODUCTS

  1. Letter of application from manufacturer/exporter/importer.
  2. Valid license to Operate. (LTO)
  3. Certificate of brand name clearance from BFAD.
  4. Product information
    • List of ingredients in decreasing order of proportion
    • Amount and technical specification of ingredients / additives used
    • Certificate from flavor supplier that the flavor components are recognized as safe and suitable for human consumption either by the US Flavor Extract Manufacturer’s association, US Food and Drug Administration, International Organization of Flavor Industry or other reputable agencies
    • Physical description and specifications of the finished product
  5. Samples of the product in its commercial presentation.
  6. Labels and labeling materials to be used for the product.
  7. Certificate of analysis. (Include analytical methods used)
  8. Method of manufacture, packaging (Food Grade Certification) and quality control.
  9. Stability data in support of declared Expiry Date.
  10. Certificate of agreement between the foreign manufacturer/distributor and the importer/local distributor.
  11. Government certificate of clearance and free sale of the product from the responsible Government Authority in the country of origin and duly authenticated by the Philippine Consulate abroad.
  12. Evidence of registration for payment. (Charge slip/Official Receipt)

 

CHECKLIST OF REQUIREMENTS FOR REGISTRATION OF IN VITRO DIAGNOSTIC PRODUCTS

  1. Letter of application from the manufacturer/trader/distributor. – one copy
  2. *Government Certificate of clearance and free sale / registration approval of the product from country of origin and duly authenticated by territorial Philippine Consulate.   – one copy
  3. *Government Certificate attesting to the status of manufacturer, competency, and reliability of the personnel and facilities, and duly authenticated by territorial Philippine Consulate.   – one copy
  4. *Certificate of agreement between the manufacturer and distributor/importer regarding the product involved.   – one copy
  5. *Certificate of brand name clearance.   – one copy
  6. *Copy of latest Certificate of Product Registration.  – one copy
  7. List of all raw materials used as components of the reagent/test kit.   – two copies
  8. Technical specifications/physical description of the finished product.   – two copies
  9. Test procedure and expected performance specifications.   – two copies
  10. Flow chart of the manufacturing procedure.  – two copies
  11. Stability studies of the product to justify claimed shelf life.   – two copies
  12. Unattached labeling materials (see attached guidelines on labeling of In Vitro Diagnostic Products).   – two copies
  13. Sufficient samples (one sample/kit in market or commercial presentation for laboratory analysis.
  14. Evidence of registration fee payment.  (* Initial Registration only **Renewal Registration only)