MARKET AUTHORIZATION APPLICATION REQUIREMENTS FOR BIOSIMILAR PRODUCTS IN SAUDI ARABIA & SINGAPORE

Main Article Content

SUHAS SHANKAR JOSHI
BALAMURALIDHARA V.
CHANDAN B. V.

Abstract

Saudi Arabia goes under the centre east nations where the endorsement of biosimilar items gives certain guidelines and endorsement pathway is talked about, Saudi Food and Drug Authority (SFDA) in Saudi Arabia. It assumes a critical part in guaranteeing security, quality and openness of human, veterinary medications, beautifiers and organic items. The rule refers to about guidelines for biosimilar items and different expenses for endorsement of the items. Singapore is arranged in eastern part, which is considered as one of Asian Countries. The method of accommodation is totally extraordinary contrasted with other country. Health science Authority (HSA) is a legal board under the Ministry of Health of the Singapore Government. It is pertinent to clinical, drug and logical ability to secure and propel general wellbeing and security. In this article the administrative rules of Saudi Arabia and Singapore is talked about and looked at the MAA prerequisites in Saudi Arabia and Singapore.

Keywords:
SFDA, HAS, MAA, Middle East, Singapore, biosimilars

Article Details

How to Cite
JOSHI, S. S., V., B., & V., C. B. (2021). MARKET AUTHORIZATION APPLICATION REQUIREMENTS FOR BIOSIMILAR PRODUCTS IN SAUDI ARABIA & SINGAPORE. Journal of International Research in Medical and Pharmaceutical Sciences, 16(3), 40-54. Retrieved from https://www.ikprress.org/index.php/JIRMEPS/article/view/6855
Section
Review Article

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