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Year : 2017  |  Volume : 37  |  Issue : 3  |  Page : 81-85

Application profile of full and abbreviated dossiers for drug master file: An experience of Taiwan

Center for Drug Evaluation, Division of Pharmaceutical Science; National Defense Medical Center, School of Pharmacy, Taipei, Taiwan, Republic of China

Correspondence Address:
I-Chen Sun
3F, No. 465, Sec. 6, Zhongxiao E. Road, Taipei 11557, Taiwan, Republic of China. Tel: +886.2.8170.6000. (Extension 300); Fax: +886-2-8170-6002
Republic of China
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jmedsci.jmedsci_111_16

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Background: In Taiwan, drug master file (DMF) serves as a useful database regarding the quality of active pharmaceutical ingredients in which both full and abbreviated dossiers can be submitted. Moreover, mandatory substances have been implemented recently, yet the details of the outcome remain unrevealed. Methods: This study aims to compare these two application profiles and their reviewing outcomes. Data were collected from the new submissions of both full and abbreviated dossiers completed between January 1 and December 31 of 2014 by the Center for Drug Evaluation, Taiwan. Results: The top two countries for DMF applications were India and China in both full and abbreviated dossier types. Drugs acting in the alimentary tract and metabolism, cardiovascular system, anti-infectives, and nervous system were the most prevalent. Majority of the abbreviated dossiers provided certification of suitability to the monographs of the European Pharmacopoeia rather than other types of documentation among the eligible documents applying for mandatory applications in which the acceptance rate was higher than that of full dossiers. Conclusions: Our data not only suggests that submission of abbreviated dossier is more effective to receive regulatory approval, but also demonstrates that the policy of health authority is a key in the improvement of reviewing process.

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