Advantages of using an abbreviated dossier for drug master file applications in Taiwan

In Taiwan, the quality of active pharmaceutical ingredients is recorded in a drug master file (DMF), the applications for which can be submitted in two dossier types, either full (complete technical information) or abbreviated (partially complete technical information with an approved document issue...

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Bibliographic Details
Published in:Regulatory toxicology and pharmacology 2016-10, Vol.80, p.310-313
Main Author: Sun, I-Chen
Format: Article
Language:English
Subjects:
Abbreviated dossier
Active pharmaceutical ingredient
Documentation - methods
Dossier type
Drug Approval - legislation & jurisprudence
Drug Approval - methods
Drug Industry - legislation & jurisprudence
Drug master file
Full dossier
Government Regulation
Humans
Review outcome
Risk Assessment
Taiwan
Time Factors
Workflow
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Summary:In Taiwan, the quality of active pharmaceutical ingredients is recorded in a drug master file (DMF), the applications for which can be submitted in two dossier types, either full (complete technical information) or abbreviated (partially complete technical information with an approved document issued by developed countries). However, the advantages of the abbreviated approach remain unknown. This study compared full and abbreviated dossier profiles and reviewed their outcomes in acceptance rates and deficiencies leading to rejection. Data were collected from new submissions of both dossier types that were completed in 2014 by the Center for Drug Evaluation, Taiwan. The results revealed that the abbreviated applications took shorter review time and had a higher acceptance rate. Among the eligible types of document for abbreviated applications, Certification of Suitability to the Monographs of the European Pharmacopeia (CEP) was the most frequently used. For categorical deficiencies, both dossier types presented the deficiencies in similar sections leading to rejection, namely Manufacture (3.2.S.2), Control of drug substance (3.2.S.4), and Stability (3.2.S.7). In summary, CEP serves a favorable document for the abbreviated DMF application in which it shortens the review time, increases the acceptance rate, and its deficiencies are similar to those of the full DMF application.
ISSN:0273-2300
1096-0295
DOI:10.1016/j.yrtph.2016.05.034