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FDA Releases Revised Guidelines on the Submission of Equivalence Evidence of Pharmaceutical Products

December 13, 2016

Philippine Food and Drug Administration (FDA) has released the ‘Revised Guidelines on the Submission of Equivalence Evidence for Registration of Pharmaceutical Products.’

The document establishes requirements for the submission of in vitro or in vivo equivalence evidence for the registration of the following pharmaceutical products:

  • Traditional/herbal medicines
  • Biological products
  • Medical oxygen
  • Veterinary drugs
  • Stem cell products

It also ‘rationalize the scope of requiring product interchangeability based on product risk.’ It took effect immediately on October 25, 2016.

Source URL: FDA Circular No. 2016-019

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