Module 9 2021

Later still in the journey

• The concept of comparability is introduced to enable assurance that changes in the manufacturing process can be shown to have no adverse effect on product Q, S & E

• The concept of biosimilarity is introduced to address the commercial imperative of genericisation (analogous to small molecule products)

• The development of high technology products such as gene and cell therapies with their contingent unknown hazards and unquantifiable risks requires significant additional control and regulation in a new category: advanced therapy medicinal products

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What is it like here?

• We are heavily regulated

– This is a good thing, but expensive

• Extensive technical guidance is available

• Guidance is harmonised

• Advice is easily accessible

• We understand established development and regulatory pathways

• Industry and regulators can collaborate

• Regulators are proactive in the face of advancing technology

• Unmet clinical needs can be addressed

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