Regulatory Updates for Pharmaceutical and Medical Devices in the Philippines

Overview

Over the past few years, the pharmaceutical and medical device markets in the Philippines have been growing 6-8 percent annually. Both the pharmaceutical and medical device markets are largely made up of imported products, valued at around $300 million and $75 million, respectively. Currently, the U.S. has a limited presence in the Philippines’ pharmaceutical market, holding less than eight percent of the market share; the U.K., Germany, France and Switzerland each hold around 10 percent. However, since the Philippines’ drug regulatory body, the Bureau of Food and Drugs (BFAD), adopted U.S. Pharmacopoeia standards, U.S. pharmaceuticals should continue to have good market potential. Companies such as Pfizer, Wyeth and Eli Lilly all have a presence in the Philippines’ pharmaceutical market. The U.S. plays a larger role in the Philippines’ medical device industry, currently possessing about 35 percent of the market.

Health Authority

The Bureau of Food and Drugs (BFAD) was established to ensure the safety, efficacy, purity and quality of health products in the Philippines. The Food, Drug and Cosmetic Act provides the regulations to monitor food, drugs, medical devices, diagnostic reagents, cosmetics and household hazardous substances in the Philippines.

Medical Devices

Initial product licenses are valid for one year. The dossier requirements for product registration include the following:

  • Free Sale Certificate from the country of origin authenticated by the Philippines Consulate
  • Physical description and specifications of the finished product
  • List and quantity of all raw materials
  • Product indications and directions for use
  • Labeling materials
  • Description of the manufacturing and packaging processes
  • Description of the sterilization procedure, when applicable
  • Stability studies, when necessary
  • Product sample
  • Notarized letter of application from the manufacturer/distributor/importer
  • Valid license-to-operate from the manufacturer/distributor/importer
  • ISO Certification or government certificate (authenticated by the Philippine Consulate) confirming the competency and reliability of the manufacturer
  • Certificate of Agreement between the manufacturer and distributor/importer for the specific product
  • Receipt showing payment of the license application fee

Renewal licenses are valid for five years. The renewal application requires the following documents and information:

  • Copy of the most recent Certificate of Product Registration
  • Product indications and directions for use
  • List and quantity of all raw materials
  • Description of the manufacturing and packaging processes
  • Description of the sterilization procedure, when applicable
  • Quality control procedures for the finished product
  • Physical description and specifications of the finished product
  • Description of the sterilization procedure, when applicable
  • Product sample
  • Notarized letter of application from the manufacturer/distributor/importer
  • Valid license-to-operate from the manufacturer/distributor/importer
  • Receipt showing payment of the license application fee

Pharmaceuticals

Product Registration

Product registration of pharmaceuticals requires the following information and documents:

  • Application for Registration of Pharmaceutical form
  • Certificate of Agreement between the manufacturer and distributor/importer for the specific product
  • Valid license-to-operate from the manufacturer/distributor/importer
  • Product formulation and dosage
  • Specifications and Certificate of Analysis for all raw materials
  • Stability studies
  • Manufacturing information, including manufacturing procedure, in-process controls, production equipment and packaging procedure
  • Labeling materials
  • Product sample

The BFAD will generally review and issue the product approval/non-approval within 180 days. An initial product license is valid for one year; renewed licenses are valid for five years.

Promotion

While the Food, Drug and Cosmetic Act provides the regulatory guidance for the Philippines’ pharmaceutical market, the Pharmaceutical Healthcare Association of the Philippines (PHAP) established its own regulations for pharmaceutical promotion in 2003, entitled the Code of Pharmaceutical Marketing Practices. Although the Code is only applicable to member companies of the PHAP, it does play a significant role in the fair and ethical promotion of pharmaceutical products in the Philippines.

Pharmaceutical promotional materials, including brochures and magazine advertisements, do not need prior approval from the BFAD. However, the materials should be submitted to the BFAD for reference. Unlike prescription drugs, OTC products can be directly advertised to the public.

Under the PHAP Code, specific information is required to accompany all pharmaceutical promotional material. The requirements for the first 12 months of promotion vary from those required after the initial 12 month period.

Material within the first 12 months of promotion should include:

  • Product brand/generic name
  • Product description
  • Dosage quantities and forms
  • Manufacturer name and address
  • Clinical information, including precautions and warnings
  • Storage conditions

Following the initial 12 month period, only the following information is required on promotional material:

  • Dosage quantities and forms
  • Indications for use
  • Routes of administration
  • Precautions, warnings and adverse effects
  • Contraindications

Sampling

Under PHAP code, member companies within the Philippines’ pharmaceutical market can provide samples to hospital-based doctors and general practitioners. However, the quantity of samples is limited to the number necessary for a doctor to conduct a meaningful clinical evaluation. Companies that are not members of the PHAP are not subject to any sample distribution restrictions.

The following information should be printed in English on the sample packaging:

  • Generic/brand name
  • Philippines product registration number
  • Name of the product license holder
  • Indications for use
  • Dosage
  • Batch number
  • Contraindications, warnings and precautions
  • Expiration date

Gift Giving

In the past, it was not uncommon for doctors to receive expensive gifts and be treated to lavish entertainment, such as resort weekends. But now, under the PHAP code, the types of gifts and other compensation provided to doctors is severely limited. The PHAP hopes to limit the influence a particular company within the Philippines’ pharmaceutical markethas on a doctor and the pharmaceutical products he or she prescribes.

Some of the gifts that companies can offer in accordance with the PHAP code include:

  • Gifts valued at less than $18
  • Gifts related to the doctor’s work, including office supplies
  • A gift that benefits a doctor’s patient