Food and Drug BlogPhilippine FDA Strengthening its Regulation in products for Marketing Authorization

July 5, 2013

The Philippine FDA is strengthening their power in ensuring the safety and efficacy of pharmaceutical products available in the Philippines. They have expanded the list of products that requires Bioequivalence Studies as part of the requirement for the application of product registration.

In 2006, by virtue of BC 2006-008 BE Study report are only required to Rifampicin containing drug products and 11 more molecules namely Atenolol, Metoprolol, Propranolol, Nicardipine, Diltiazem, Gliclazide, Metformin, Phenytoin, Pyrazinamide and Theophylline.

With the introduction of many off-patent, multisource, pharmaceutical products in the market, particularly those with known or potential bioavailability problems, whether manufactured locally or sourced abroad, and have not undergone in vivo BE studies or even in vitro multipoint dissolution testing, FDA recognizes the need to ensure that these products perform similarly as the innovator drug, and are interchangeable in clinical practice.

Products requiring the submission of satisfactory BE Study Reports which can be found from FDA Circular 2013 -14:

  1. Class 4 Drugs (Low Solubility, Low Permeability)
  2. Class 3 Drugs (Low Permeability, High Solubility)
  3. Class 2 Drugs (High Permeability, Low Solubility)
  4. Class 1 Drugs (High Permeability, High Solubility)

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