Open AccessApplication profile of full and abbreviated dossiers for drug master file: An experience of Taiwan
Author(s) -
I-Chen Sun
Publication year - 2017
Publication title -
yīxué yánjiū zázhì/journal of medical sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.176
H-Index - 12
eISSN - 2542-4939
pISSN - 1011-4564
DOI - 10.4103/jmedsci.jmedsci_111_16
Subject(s) - documentation , certification , pharmacopoeia , medicine , quality (philosophy) , library science , family medicine , business , political science , computer science , alternative medicine , law , philosophy , epistemology , pathology , programming language
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