Ensuring a stable supply of APIs in Japan

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A stable supply of active pharmaceutical ingredients (APIs) is indispensable for a stable supply of finished pharmaceutical products (FPPs). It is also indispensable for promoting the use of generics, because API distribution issues can lead to generics shortages. For instance, of the 46 drug shortage problems that arose in FY2013, 21 were associated with API shortages [1]. These shortages can result in a perception among medical staff and patients that generic drugs are unreliable. Therefore, minimizing the risk of API shortage is crucial for promoting the use of generics.

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In Japan, API manufacturers generally register API information as a Drug Master File (DMF) directly to Japan’s drug regulator, the Pharmaceuticals and Medical Devices Agency (PMDA). This system enables for API information, including confidential intellectual property, to be provided by API manufacturers to the PMDA directly, without disclosing protected information to the applicant [2].

Because DMFs require appropriate management by their registrants, it is important to clarify the DMF registrants’ distribution. However, despite globalization of the API supply chain, details regarding the DMF registration situation in Japan have not been reported. Therefore, researchers from the PMDA surveyed the status of globalization and characteristics of DMF registrations in Japan [3].

Authors Maki Matsuhama and Ryosuke Kuribayashi examined the total number of DMFs, the number of DMFs by country and region of registrants, the trend in the number of DMFs registered in Japan by region, and the number of DMFs for the same APIs, using DMF registration information as of 31 March 2017 on the PMDA website.

The results showed that of the 3,804 DMFs registered in Japan, 63.46% were registered by foreign manufacturers. DMFs were registered from 46 countries and regions and from all seven continents of the world. Most were registered by Asian (70.11%) and European (24.42%) manufacturers, including China, India, Japan, South Korea, Italy and Spain. In recent years, approximately 200–300 DMFs have been registered annually. Ten or more DMFs were registered for APIs in the top 30 FPPs by use in Japan.

The authors concluded that ‘for the appropriate management of DMFs, it is very important that the Japanese DMF system and its related regulations are understood by all DMF registrants including foreign ones’. Furthermore, they pointed out that ‘it is essential that the DMF system and its associated regulations are globally convergent to promote easy registration and management of DMFs. Finally, they added that their results ‘represent key considerations for future DMF systems and regulations, corresponding to the globalization of DMF registration’.

Conflict of interest
The authors of the research paper [3] declared that there were no conflicts of interest.

Editor’s comment
This article for GaBI Online is a summary of the full article published in GaBI Journal.

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1. Ministry of Health, Labour and Welfare. Mitsubishi UFJ Research & Consulting Co., Ltd. Business report on verification and investigation of road map in FY 2014 [homepage on the Internet]; [cited 2018 Nov 9]. Available from: www.mhlw.go.jp/file/06-Seisakujouhou-10800000-Iseikyoku/0000095057.pdf (Japanese)
2. Pharmaceuticals and Medical Devices Agency. Guideline on utilization of Master File for drug substances. 2005 Feb 10 [homepage on the Internet]; [cited 2018 Nov 9]. Available from: www.pmda.go.jp/files/000153843.pdf
3. Matsuhama M, Kuribayashi R, Analysis of Drug Master Files registered in Japan: aiming for a stable supply of active pharmaceutical ingredients. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):8-13. doi:10.5639/gabij.2018.0701.003

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