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

Announcement no. 0980363183, 2009 Announcement no. 1001403285, 2011 Announcement no. 1011410816, 2012 Announcement no. 1031413560, 2015 Background & legal framework: Resolution AP-CSP (07) 1 on Certification of suitability to the monographs of the European Pharmacopoeia (revised version). European Directorate from the Quality of Medicines and Healthcare. Available at: https://www.edqm.eu/site/certification-background-77.html. (accessed 07.03.16.). Borg, 2009, Where is industry getting it wrong? A review of quality concerns raised at day 120 by the committee for medicinal products for human use during european centralised marketing authorisation submissions for chemical entity medicinal products, J. Pharm. Pharm. Sci., 12, 181, 10.18433/J3FW2Q Certification: Search Database Online. Available at: https://extranet.edqm.eu/publications/Recherches_CEP.shtml. (accessed 07.03.16.). CPG Sec. 490.100: Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-market Approval. http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074411.htm (accessed 07.03.16.). 1989 EDQM-Taiwan FDA agreement signing ceremony and symposium on May 2014. http://www.fda.gov.tw/EN/siteContent.aspx?sid=4084 (accessed 07.03.16.). 2013 2011 2004, 1 Ortega Diego, 2014, Review of quality deficiencies found in active pharmaceutical ingredient master files submitted to the WHO Prequalification of Medicines Programme, J. Pharm. Pharm. Sci., 17, 169, 10.18433/J3Q60J Progress update Health Canada’s Use of the European Directorate for the Quality of Medicines and Healthcare’s Certificate of Suitability and the signing of a Memorandum of Understanding. Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/int/edqm_2007-eng.php (accessed 07.03.16.). Schwartz, 2006, Drug master file review issues at the Office of Generic Drugs, J. Generic Med., 3, 280, 10.1057/palgrave.jgm.4940130 Sun, 2014, Regulatory status of drug master file in Taiwan 2009–2011, J. Generic Med., 10.1177/1741134314555879 Sun, 2016, Effect of regulation reform on clinical trials for registering novel therapeutic agents in Taiwan: a chronological analysis, Investig. New Drugs, 34, 364, 10.1007/s10637-016-0322-2 The Designated Countries Include Australia, Canada, Japan, UK, USA, France, Switzerland, Germany, Belgium, and Sweden listed in Article 7 of Taiwan “Regulations for Registration of Medicinal Products” on version of May 7, 2015. Top Ten Deficiencies: New Applications for Certification of Suitability (2011) Certification of Substances Division, European Directorate from the Quality of Medicines and Healthcare. Available at: https://www.edqm.eu/medias/fichiers/paphcep_12_15.pdf. (accessed 07.03.16.). Zhang, 2014, Completeness assessment of type II active pharmaceutical ingredient drug master files under generic drug user fee amendment: review metrics and common incomplete items, AAPS J., 16, 1132, 10.1208/s12248-014-9630-7