MFDS to Conduct Equivalence Re-evaluation of Pharmaceuticals Next Year... Targeting 379 Items
207 Eye Drops, 7 Eye Ointments, and More
[Asia Economy Reporter Kim Ji-hee] The Ministry of Food and Drug Safety announced on the 28th the items and deadlines for the re-evaluation of pharmaceutical equivalence for eye drops, eye ointments, and other drugs.
Pharmaceutical equivalence evaluation is a test conducted to prove the equivalence of two formulations with the same active ingredient, content, and dosage form. It includes biological equivalence evaluation, which statistically proves equivalence in bioavailability, and physicochemical equivalence evaluation, an in vitro test that proves equivalence in physical and chemical properties.
The drugs subject to this re-evaluation include a total of 379 items by formulation: ▲207 eye drops ▲7 eye ointments ▲18 inhalants applied to the lungs ▲147 external preparations.
Companies holding the re-evaluation target items must submit the re-evaluation application and pharmaceutical equivalence test plan by December 31 of this year, and the result report by September 30 of next year. However, for eye drops, eye ointments, and external preparations (local action) where biological equivalence testing is difficult due to the route of administration or mechanism of action, the physicochemical equivalence test result report must be submitted by the end of this year.
The Ministry of Food and Drug Safety is continuously expanding the scope of drugs for which pharmaceutical equivalence test data must be mandatorily submitted upon new item approval to strengthen safety management of pharmaceuticals. This re-evaluation was prepared to assess the quality suitability of items approved before the mandatory implementation.
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If the companies subject to re-evaluation fail to submit the data within the deadline, they will face administrative sanctions such as suspension of business. Items that fail to prove equivalence in the pharmaceutical equivalence test will be subject to license cancellation and recall measures.
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