ABSTRACT

Regulatory affairs is a department that is responsible to protect the public health by controlling the safety and efficacy of the product. RA deals in an area like pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemical, cosmetics, and complementary medicines. New Drug Registration is a medium through which the sponsors provides that the regulatory authority has approved a new pharmaceutical product for sale and marketing. Registration provides the information of drug and allow the regulatory agencies to ensure the benefits exceeds the risk. Different countries have their own registration process following their own guidelines and provisions. This review particularly focuses on the registration process followed in Japan. Beyond language obstacles, Japan's drug approval and review procedure is simpler and less complicated than in some other nations. The PMDA offers sponsors counselling to help them understand the requirements and the step-by-step process for drug approval, in addition to regulatory aspects. Because of this, a lot of manufacturers select Japan as their drug market. One of the biggest markets in the world for pharmaceuticals is Japan. According to data from the Ministry of Health, Labour, and Welfare; the market value, which includes over-the-counter drugs is about $95 billion (MHLW). Keywords: PMDA: Pharmaceuticals and Medical Devices Agency, MHLW: Ministry of Health, Labour and Welfare, CTD: Common Technical Document, ICH: International Council for Harmonization, RA: Regulatory Affairs
Publication date: 01/11/2024

https://ijbpas.com/pdf/2024/November/MS_IJBPAS_2024_8295.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.11.8295