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KMID : 1142220180130020099
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Regulatory Research on Food, Drug & Cosmetic
2018 Volume.13 No. 2 p.99 ~ p.104
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The Consigned/Co-Bioequivalence Study Regulations Impact on Domestic Pharmaceutical Industry
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Park Ye-Jin
Choi Eun-Young
Nam Kyu-Yeol
Kwon Kyoung-Ae
Jung Won-Tae
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Abstract
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In order to obtain approval for the generic drugs, bioequivalence study (BE study) is required to be conducted to demonstrate biological equivalence with the reference drug product. Since the current domestic regulations allow BE study performed by consortium of pharmaceutical companies, the consignor can be exempted from submitting the bioequivalence data when the consignee verifies the bioequivalence. As a result, the consigned/ co-BE study of generic drug was increased, while the number of companies developing independent generic drug were decreased. Therefore, the approved generic drugs that did not directly demonstrate bioequivalence were accounted for more than 80%. This situation has prompted the excessive competition of generic drugs, market confusion, and decrease in R&D investment. It leads to decline competitiveness of domestic pharmaceutical industry. On the other hand, overseas regulatory authorities do not permit consigned/co-BE study of generic drug. Therefore, all generic drugs need to be approved through BE study or clinical trial. Consigned/co-BE study should be abolished to enhance the competitiveness of domestic pharmaceutical industry and to improve the quality of generic drugs. However, suddenly the introduction of new regulations could cause confusion to many domestic pharmaceutical companies. In order to encourage the company to conduct BE study independently without any side effects by changed regulations, several policies should be considered as follows. 1) Providing the compensation to the company that conducted BE study independently. 2) Providing more information to doctors for prescribing a generic drug with considering whether or not consignment. 3) Supporting the small or medium company.
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KEYWORD
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Bioequivalence study (BE study), Consigned/Co- BE study, Generic drug
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