Module 9 2021

Evolution of regulation

Biologics and drugs become separate product classes

• Final product testing dominated safety assurance for drugs

• Process and facility controls were used to regulate biologics

• Such was the nature of the products and technologies of the day available for their production and analysis

• This was the origin of the dual (establishment and product) licence system for biologics in the US

The Organisation for Professionals in Regulatory Affairs

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Later in the journey

The biotechnology revolution of the ‘70s and ‘80s

• Genetic manipulation and recombinant gene expression • Monoclonal antibody technology • Protein engineering • Enormous advances in analytical and manufacturing technologies

• Commercially viable routes to replace existing products and satisfy unmet clinical needs de novo • Greater safety assurance through product knowledge and process control

The Organisation for Professionals in Regulatory Affairs

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