In:
International Journal of Research in Pharmaceutical Sciences, GP Innovations Pvt. Ltd., Vol. 12, No. 2 ( 2021-04-07), p. 1081-1085
Abstract:
For the development of new drug, it requires a greater amount of research work in chemistry, Manufacturing, control, Preclinical and clinical trials. The drug approval process in all regulatory market carrying responsibilities on multiple factors such as data, safety, efficacy to public health in a country. Current constrain of affairs reveals diverse countries need to follow different regulatory requirements for Regulatory approval process for marketing drug in the different regulatory market of the country to ensure safety and efficacy of the product. In order to conduct a regulatory process for approval of a drug, every country has their unique regulation, guidelines, legislation and respective regulatory authority. Japan has its own regulatory authority for drug and medical device called the Ministry of Health, Labour, and Welfare (MHLW), Pharmaceuticals and Medical Devices Agency (PMDA), respectively. In the Japan Ministry of Health, Labour, and Welfare are overseeing the approval procedure of New drug, Generic Drug and Orphan Drug also. In that regard, the Drug Approval process followed in Japan ensures that every company has adhered to specific guideline available in their respective website. The drug comes to market with safety, efficacy to enhance the health of people in Japan by scrutinised process. It results into the longevity of human, which is so apparent in their demographic chart of Japan's Population.
Type of Medium:
Online Resource
ISSN:
0975-7538
DOI:
10.26452/ijrps.v12i2
DOI:
10.26452/ijrps.v12i2.4636
Language:
Unknown
Publisher:
GP Innovations Pvt. Ltd.
Publication Date:
2021
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