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Regulatory Requirements for Registration of Generic Drug Products in Japan

Sudi Daniel, Mudit Dixit


Drug registration is a procedure of expertise of the pharmaceutical product quality, efficacy and safety by regulatory authority. The emergence of various formats has enabled the manufacturers of drugs to easily gain access into various markets and thus, was able to place their products in the market. The choice of Japan as one of the destinations for the market of the Drug products ensures the manufacturer a good market value. Japan is considered as one of the strongest and promised markets for the registration of the drugs. Of late, generic drugs are holding major stake in the pharmaceutical market and are gaining more and more confidence in the usage. Majority of medicines in Japan are generic drugs which are considered as value for the money and affordable. Generic drugs are pharmaceutical products that are approved for manufacture, and are prescribed as drugs with equivalent therapeutic effects to those of the original drugs. The quality, safety and efficacy of the generic drugs do not differ from those of the original drugs. In Japan, the expiry of drug patents has given rise to many generic products. The reduction in price provides its availability for the public in a cheaper price. Pharmaceuticals and Medical Devices Agency (PMDA) carries out the registration process of drug products in Japan. The registration process mainly includes specification, accelerated stability studies and bioequivalence rather than complete tests required for an innovator drug.


Keywords: PMDA, MHLW, generics, CTD, bioequivalence

Cite this Article

Daniel Sudi, Dixit Mudit. Regulatory requirements for registration of generic drug products in Japan. Trends in Drug Delivery. 2015; 2(2): 19–27p

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