Brief introduction for search and determination of the comparator product for generic medicinal product application in the EU

doi:10.5246/jcps.2018.11.081

Journal of Chinese Pharmaceutical Sciences ›› 2018, Vol. 27 ›› Issue (11): 805-812.DOI: 10.5246/jcps.2018.11.081

• Drug administration and clinical pharmacy column • Previous Articles Next Articles

Brief introduction for search and determination of the comparator product for generic medicinal product application in the EU

Jianzhao Niu, Dongsheng Yang, Mingdi Xu^*

National Institutes for Food and Drug Control, Beijing 100050, China

Received:2018-08-30 Revised:2018-10-16 Online:2018-11-28 Published:2018-10-23
Contact: Tel.: +86-010-67095371, E-mail: xumingdi@nifdc.org.cn
Supported by:
National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’ (Grant No. 2017ZX09101001, Beijing, China).

Abstract

Abstract:

It is vital segment to choose the right comparator product during the development and study of generic medicinal product, and this is also definitely specified in the relevant documents from the China Food and Drug Administration (CFDA) that the comparator product should be innovator product or internationally recognized same medicinal product, which is used in the re-evaluation of generic medicinal product or marketed authorization application of the generic medicinal product. To facilitate the domestic and foreign pharmaceutical enterprises to choose and determine comparator product, four medicinal product evaluation procedures, as well as the corresponding marketed medicinal product list, are detailed elaborated in this paper. At the same time, by taking the Mifepristone Tablet (200 mg) as example, the search and determination process of the comparator product for generic medicinal product application in the EU is illustrated with the combination of different marketed medicinal product lists.

Key words: Comparator product, Re-evaluation of generic medicinal product, Marketing authorization application, Mifepristone tablet

CLC Number:

R951

Supporting:

Jianzhao Niu, Dongsheng Yang, Mingdi Xu. Brief introduction for search and determination of the comparator product for generic medicinal product application in the EU[J]. Journal of Chinese Pharmaceutical Sciences, 2018, 27(11): 805-812.

References

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Brief introduction for search and determination of the comparator product for generic medicinal product application in the EU

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