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Research Journal of Pharmacy and Technology
Year : 2019, Volume : 12, Issue : 9
First page : ( 4531) Last page : ( 4538)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2019.00780.7

Registration Requirement and Approval Procedure of Vaccines in Saudi Arabia

Raghotham S.1, Balamuralidhara V.2,, Karuna Kamireddy3

1Research Scholar, Regulatory Affairs Group, Department of Pharmaceutics, JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagara, Mysore – 570015, Karnataka, India

2Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagara, Mysore – 570015, Karnataka, India

3M. Pharmacy, Regulatory Affairs Group, Department of Pharmaceutics, JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagara, Mysore – 570015, Karnataka, India

Corresponding Author E-mail: raghothams7562@gmail.com, baligowda@jssuni.edu.in, karunakamireddy9@gmail.com

Online published on 24 December, 2019.

Abstract

Vaccination is one among the foremost cost-efficient health interventions out available, saving a lot of individuals from illness, incapacity, and death annually. So that it is very much essential for the people on time vaccination. Due to the variation of regulatory requirements and process in developing and emerging countries leads to set back vaccine's registration and therefore marketing a high-quality, safe and efficacious vaccines are delayed for their respective populations. This article focuses on providing clear registration requirements and approval procedure for vaccines in Saudi Arabia for marketing authorisation applications for vaccines and also tells the clear pathway for submission and approval of dossier for Saudi Arabia. The Module 1 of the Common Technical Document (CTD) and Modules 2–5 of the CTDs requirements are same as ICH CTD (Exceptions for some of the tests that we do not carry out for vaccines). A dossier containing detailed information about the vaccines and results of the studies carried out in its development process. Characterise the registration requirement and current regulatory review process used at SFDA, identifying agency review models as well as key milestones and timelines.

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Keywords

Vaccine, CTD, Dossier and Approval Process.

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