title: Advantages of using an abbreviated dossier for drug master file applications in Taiwan.
abstract: 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.
authors.affiliation: Division of Pharmaceutical Science, Center for Drug Evaluation, Taipei, Taiwan, ROC; School of Pharmacy, National Defense Medical Center, Taipei, Taiwan, ROC. Electronic address: icsun@cde.org.tw.
authors.forename: I-Chen
authors.initials: IC
authors.lastname: Sun
mesh_terms: D004282:Documentation / Q000379:methods*; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods*; D004345:Drug Industry / Q000331:legislation & jurisprudence; D033161:Government Regulation; D006801:Humans; D018570:Risk Assessment; D013624:Taiwan; D013997:Time Factors; D057188:Workflow
keywords: Abbreviated dossier; Active pharmaceutical ingredient; Dossier type; Drug master file; Full dossier; Review outcome