MadgeTech Blog

Regulatory Oversight of Vaccines

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Vaccines are crucial in thwarting the spread of infectious diseases and are responsible for preventing 4 to 5 million deaths every year, that according to the World Health Organization. But before vaccines can be released for distribution, it takes several years to conduct both extensive lab testing and clinical trials. It’s a lengthy, but necessary process that includes the following government agencies to ensure vaccine safety.

NRAs
National Regulatory Authorities are national regulatory agencies responsible for ensuring that products released for public distribution are evaluated properly and meet international standards of quality and safety and efficacy. Vaccines are subject to rigorous testing and oversight by manufacturers and NRAs. 

FDA
The Federal Drug Administration is the NRA in the United States responsible for assuring quality, safety, and effectiveness of all human medical products, including vaccines for human use. It’s responsible for overseeing the regulation of therapeutic and preventative vaccines against infectious diseases.

CDC
Centers for Disease Control and Prevention is a component of the Department of Health and Human Services. The agency’s main goal is the protection of public health and safety through the control and prevention of disease

ACIP
The Advisory Committee on Immunization Practices is a group of medical and public health experts that develop recommendations on how to use vaccines to control disease in the United States. The Committee’s recommendations on effective control of vaccine-preventable diseases are forwarded to CDC’s Director for approval. 

VFC
Vaccines for children is a federally funded program that provides vaccines at no cost to children who might not otherwise be vaccinated because of the inability to pay. The CDC buys vaccines at a discount and distributes them at no charge to registered VFC providers.

WHO
The World Health Organization is a specialized agency of the United Nations responsible for international public health. Its primary role is to direct international health within the United Nations’ system and to lead partners in global health response.


From the time they are manufactured until they are administered, vaccines must be properly stored and handled to guarantee vaccine potency the safety of public health. To ensure time/temperature requirements are properly maintained throughout the vaccine cold chain, data loggers are often implemented into the vaccine management plan.

MadgeTech offers a selection of data logging solutions specifically for the continuous monitoring of vaccine temperature. Designed to comply with CDC and VFC requirements, MadgeTech data loggers not only safeguard vaccines but also assist with 21 CFR Part 11 requirements.

To learn more about MadgeTech’s vaccine temperature monitoring systems, call us at (603) 456-2011 or email [email protected].

About Kelly:

Kelly Wright joined the MadgeTech team in May of 2016 as a Marketing Content Writer, bringing with her years of education and firsthand experience in media and communications. Kelly is a key contributor in researching and developing interesting, valuable content. As a certified HACCP manager, Kelly demonstrates her expertise at events and tradeshows around the country representing MadgeTech.