Module 9 2021

Evolution of Regulation

Realisation of the ‘90s

• Process technology and validation can address safety in manufacture

• Analytical technology approaches the standards for small molecule testing

• Safety of the product can be separated from the safety of its process?

Can biotech products therefore be regulated like synthetic drugs?

The Organisation for Professionals in Regulatory Affairs

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Who joined us on the way?

Regulators • Setting standards and providing oversight • Responsible for: – Assessing purity, potency and safety – (Later: quality, safety and efficacy) – Providing technical guidance – Managing the regulatory approval process – Accountable to their respective populations • Diverse requirements and systems evolved – Individual governments responsible for public health – No prospect of mutual recognition

• Multinational marketplace inaccessible – Retarding effect

The Organisation for Professionals in Regulatory Affairs

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