CRED Getting the CMC Dossier Right 2024

28/08/2024

Registration Challenges: Acceptance rates for small molecules of initial control strategy per section and region

Data assessment of Module 3 documents, that are key to control strategy, where 11 companies submitted 112 marketing applications in USA, EU, Japan and Canada.

Likelihood of core Accepted

S.2.2 Accepted

S.2.3 Accepted

S.2.4 Accepted

S.4.1 Accepted

S.7 Accepted

P.3.2 Accepted

P.3.3 Accepted

P.3.4 Accepted

P.5.1 Accepted

P.8 Accepted

Country Submissions

USA

17

88% 88% 88% 65% 82% 88% 71% 71% 29% 76% 75%

Japan

12

50% 42% 50% 58% 92% 67% 50% 75% 17% 83% 58%

EU

19

42% 16% 26% 26% 84% 63% 37% 58% 21% 63% 44%

Canada

16

81% 56% 94% 69% 94% 75% 31% 50% 50% 75% 68%

64

66% 50% 64% 53% 88% 73% 47% 63% 30% 73% 61%

Leads to region specific commitments

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IQ Consortium Confidential

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Registration Challenges: Impact of divergence

The Organisation for Professionals in Regulatory Affairs

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