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Drugs subject to 2nd evaluations may submit data by Oct

By Lee, Tak-Sun | translator Kim, Jung-Ju

23.02.08 05:50:46

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Period was extended in consideration of inevitable circumstances as for the drugs that received 1st evaluations

The changes were briefed to companies on the 10th... drugs that did not select reference drugs, etc. will be able to earn time to conduct bioequivalence tests and generate required data



Drugs that were to receive the 2nd series of reevaluations by HIRA and were required to submit data by July will also be deemed to have met their requirements even if they exceed their submission deadline and submit the Ministry of Food and Drug Safety review completion notice by the end of the objection period.

This will allow companies an additional 3 months of time, until October, to submit data. The measure has been made in consideration of the unavoidable circumstances, just as the first series of drugs that were subject to receive evaluations this year.

According to the Health Insurance Review and Assessment Service on the 7th, oral and sterile preparations that were subjec

Lee, Tak-Sun(hooggasi2@dailypharm.com)
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