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

Full Article - PDF

Published: 2021-08-13

Page: 40-54


SUHAS SHANKAR JOSHI

Pharmaceutical Regulatory Affairs Group, Department of Pharmaceutics, JSS college of Pharmacy Mysuru, JSS Academy of Higher Education and Research, Mysuru – 570015, Karnataka, India.

BALAMURALIDHARA V. *

Pharmaceutical Regulatory Affairs Group, Department of Pharmaceutics, JSS college of Pharmacy Mysuru, JSS Academy of Higher Education and Research, Mysuru – 570015, Karnataka, India.

CHANDAN B. V.

Pharmaceutical Regulatory Affairs Group, Department of Pharmaceutics, JSS college of Pharmacy Mysuru, JSS Academy of Higher Education and Research, Mysuru – 570015, Karnataka, India.

*Author to whom correspondence should be addressed.


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


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://ikprress.org/index.php/JIRMEPS/article/view/6855

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