Significant differences on submission lag following regulation reform for registration of novel therapeutic drugs in Taiwan
Drug lag, which delays patients’ access to medicinal products, is typically associated with pharmaceutical regulations. To shorten drug lag, health authorities may establish new policies to liberalize the regulations, a step that is important in countries, such as Taiwan, with consumer demand for imported novel therapeutic agents. Taiwan’s government enacted Articles 38–1 and 38–2 of Regulations for Registration of Medicinal Products to relax the regulatory barriers for new drug submission, thus conditionally exempting the requirement for the Certificate of Pharmaceutical Product (CPP). This study examined whether the enacted regulations reduce submission lag by analyzing the time gap of submission between Taiwan and the United States during 2014–2017. The results indicated that the enacted regulations substantially affected submission lag. Submission lag was significantly shorter for applications not requiring a CPP than those requiring one CPP, which in turn was significantly shorter than those requiring two CPPs. This conclusion can be applied to biological, chemical, non-orphan, and oncology drugs and also applications filed by subsidiary companies, but not orphan drugs and applications filed by contract agents. Among applications requiring one CPP, oncology drugs showed the shortest submission lag. Certain factors, such as clinical studies recruiting over-threshold Taiwanese participants and those performed before the submission of new drug application in the United States, may shorten submission lag. In summary, this study justifies the policy of the exemption from CPP requirements, which supports the hypothesis that relaxing regulatory barriers can reduce submission lag in Taiwan.
KeywordsSubmission lag Regulation reform Certificate of Pharmaceutical Product Clinical study Article 38–1 Article 38–2
The work was supported by the grant MOHW107-FDA-D-113-000443 from Ministry of Health and Welfare, Taiwan.
Compliance with ethical standards
Conflict of interest
I-Chen Sun declares that she has no conflict of interest.
This article does not contain any studies with human participants or animals performed by any of the authors.
- 1.Chung CJ, Huang WF (2006) A study on drug innovation lag in Taiwan. J Food Drug Anal 14(1):1–6Google Scholar
- 2.Wileman H, Mishra A (2010) Drug lag and key regulatory barriers in the emerging markets. Perspect Clin Res 1(2):51–56Google Scholar
- 6.Pharmaceuticals and Medical Devices Agency, Japan (2012) Basic principles on global clinical trials. Notification No. 0928010Google Scholar
- 10.A10 countries include Australia, Belgium, Canada, France, Germany, Japan, Sweden, Switzerland, UK, and USA referred to Article 7 of Regulations for Registration of Medicinal Products, Ministry of Health and Welfare, Taiwan (2018)Google Scholar
- 11.Chern HD (1997) Current status of clinical trials and GCP in Taiwan. TIRS 31:1097–1103Google Scholar
- 12.Bureau of Pharmaceutical Affairs, Department of Health, Taiwan (1979) Regulations for Registration of Medicinal ProductsGoogle Scholar
- 13.World Health Organization (WHO) Collaborating Centre for Drug Statistics Methodology (2013) Guidelines for ATC classification and DDD assignment. WHO Collaborating Centre for Drug Statistics Methodology, OsloGoogle Scholar
- 14.Bureau of Pharmaceutical Affairs, Department of Health, Taiwan (2001) Announcement 0900039753 Revision of registrations of medicinal productsGoogle Scholar
- 16.Yamashita K, Kaneko M, Narukawa M (2018) A significant anticancer drug approval lag between Japan and the United States still exists for minor cancers. Clin Pharmacol Ther. https://doi.org/10.1002/cpt.1136