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THE PHARMA REVIEW (JULY – AUGUST 2020)

Registration Requirement and Approval Procedure of Vaccines in Ukraine

Raghotham.S, Balamuralidhara V* & Kamireddy Karuna

Introduction: 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. Vaccines are products of biological origin that exhibit some inherent variability. They are characterized by advanced manufacturing processes and are administered to a huge number of healthy youngsters, adolescents, and adults. Their quality cannot be assessed by testing the ultimate product alone. The vaccine industry is highly regulated. Vaccines development maybe an advanced and long method. Before a new vaccine is approved for release into the market, a rigorous restrictive procedure to assess quality, effectiveness, and safety should be undertaken. 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. Throughout the life-cycle of development, from preclinical studies to licensure, vaccines are subjected to rigorous testing and oversight. Manufacturers should adhere to good manufacturing practices and management procedures to make sure the quality of vaccines. This article focuses on providing clear Registration requirements and approval procedure for vaccines in Ukraine for marketing authorisation applications for vaccines and also tells the clear pathway for submission and approval of dossier for Ukraine. 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). Characterise the registration requirement and current regulatory review process used at SMDC, identifying agency review models as well as key milestones and timelines.

 

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