IPQ Final | Page 5

Monthly Update/ September 2023

In this four-part story, IPQ explores the latest advancements in the EMA and FDA innovation support programs and the priorities that are now drawing front-burner attention.

PART I: European Regulatory Network Support for Manufacturing Innovation

The first part of the story highlights the evolution of regulatory support for biomanufacturing in Europe, sharing insights from two leading European biotech CMC reviewers.

the ARticle

News in depth

September 2023

The advancing CMC innovation support programs at EMA and FDA are highly complementary in focus and structure, with distributed and continuous manufacturing drawing significant up-front attention at both agencies.

On both sides of the Atlantic, a significant effort is underway to deepen the regulator/industry/academia communication needed to realize the potential for technological advancement in the manufacturing and control arena.

Included are the outcomes of the first year of operation of EMA’s Quality Innovation Group and its inaugural “Listen and Learn Focus Group” meeting on continuous and decentralized manufacturing, in which European, U.S. and Japanese regulators, industry, and academia participated. Pharma legislation has been proposed by the EC that targets further support for pharmaceutical innovation, including decentralized manufacturing.

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