Impact of Quality by Design Development on the Review Period of New Drug Approval and Product Quality in Japan
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ORIGINAL RESEARCH
Impact of Quality by Design Development on the Review Period of New Drug Approval and Product Quality in Japan Eiji Kajiwara, MSc1,2 · Haruki Kamizato2 · Mayumi Shikano, PhD2 Received: 30 January 2020 / Accepted: 13 March 2020 / Published online: 24 March 2020 © The Drug Information Association, Inc 2020
Abstract Background For pharmaceutical products, an in-depth understanding of manufacturing processes and quality risks associated with quality by design (QbD) development enables the production of high-quality products. Product recall due to quality issues could be minimized for QbD-developed products. Furthermore, the review period instituted by regulatory authorities could be shortened by allowing reviewers to access technical documents with QbD elements. The aim of this study was to examine the impact of QbD development from the viewpoints of regulatory flexibility, product quality related to recall, and review period in Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Methods QbD developments for new active ingredients, approved from 2009 to 2018, were surveyed in the PMDA review reports, and review periods were investigated on the PMDA website. Voluntary product recalls and their rationale were investigated using the website of the Japan Ministry of Health, Labour and Welfare. Results Although the developmental ratio with QbD elements was increased from 9% in 2009 to 71% in 2018, the development of design space for drug substances and products between 2009 and 2018 was only 2%, and real time release testing (RTRT) for drug products was limited to 3%. Voluntary recall and extension of the review period for QbD-developed products were not observed. Conclusion The advantages of systematic QbD development were suggested for no voluntary recall of QbD-developed products. Conversely, applicants did not actively seek regulatory flexibility with design space or RTRT, and QbD development failed to impact the PMDA review period. Keywords Recall · Quality by design (QbD) · Review period · Real time release testing (RTRT) · Design space
Introduction Concepts of quality by design (QbD) evolved in the early 1970s, and pharmaceutical QbD was released by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q8(R2) guideline, which reached step 4 in August 2009 [1, 2]. In this guideline, QbD is defined as “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality * Eiji Kajiwara [email protected] 1
MSD K.K, Kitanomaru Square, 1‑13‑12 Kudan‑kita, Chiyoda‑ku, Tokyo 102‑8667, Japan
Department of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan
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risk management”. Applicants are encouraged to use an enhanced QbD approach to facilitate a robust manufacturing process to ensure high-quality pharmaceutical products. A holistic QbD development usually
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