Supply Chain Management & Quality Assurance
Supply and Distribution
All manufacturing sites must be listed in the approval documents, so establishing a supply chain before submitting the new drug application is necessary. If a system can ensure product quality, importing finished or intermediate products is possible. In either case, acceptance tests and shipping tests for the products are generally required although some tests may be omitted in countries that have Mutual Recognition Agreements (MRA) for GMP.
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Due to the short timeframe from approval to price listing and launch*, it is advisable to address any necessary technology transfers, such as manufacturing or analytical method technology transfer, before submitting the NDA.
*This period usually falls within a maximum of 6 months. There is a rule that requiring the product to be launched within 90 days after price listing. -
Generally, pharmaceutical companies do not sell directly to healthcare institutions in Japan. However, wholesale companies have started initiatives to directly deliver some orphan drugs to patients.
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Although Good Distribution Practice (GDP) has not been legislatively mandated yet in Japan, GDP guideline exists, primarily outlining the responsibilities of wholesalers.
If you would like to know more about supply chain management in Japan,
Quality Assurance
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In Japan, in addition to GMP, there is a requirement for "GQP“ (Good Quality Practice) that marketing authorization holders (MAH) ensure product quality. The responsibility for market release of products in the Japanese market lies with the MAH.
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MAH is required to directly enter into quality agreements with overseas manufacturing sites and establish a system for quality assurance for each product. MAH QA ensures appropriate management of manufacturers.
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Before NDA approval, GMP compliance inspections are conducted (document-based, and on-site inspections if applicable).
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Proper transportation testing is necessary, and the impact of transportation on product quality needs to be appropriately evaluated.
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In principle in Japan, acceptance tests of products and release tests to ensure compliance with all specifications are required for product release. In countries with a Mutual Recognition Agreement (MRA) for GMP, it may be possible to omit some quality tests by accepting the test results conducted in those countries.
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In the Japanese market, "Cosmetic Issues" often pose challenges, and it is desirable to conduct visual inspections that meet the requirements of the Japanese market.
