Jeg graver litt. Kommer tilbake om jeg finner noe av interesse. China har en praksis for å akseptere tidligere data from EU+ og US. Men akkurat nå så har forholdet mellom EU og Kina gått litt surt.
For ordens skyld og med fare for å gjenta meg selv, så refererte jeg til en anmodning fra IOVaxis/Targovax datert 3. februar om å få et “class II - meeting” med CDE, som pr definisjon dekker det følgende:
- pre-application meeting for phase I clinical trials to address major technical issues prior to the first submission of the clinical trial application, including but not limited to the following issues for discussion: whether existing research data adequately support the proposed Phase I clinical trial; whether the risk of clinical trial subjects can be controlled.
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Meeting before the end of Phase II clinical trial/pre-start of Phase III clinical trial to address major technical issues after the end of Phase II clinical trial and before the start of the critical Phase III clinical trial, including but not limited to the following issues: whether the existing research data adequately support the proposed Phase III clinical trial; evaluation of the Phase III clinical trial plan and clinical trial protocol.
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Meeting before NDA application to discuss whether the existing study data meet the requirements for marketing a new drug, including but not limited to the following issues: whether the existing study data adequately support the new drug marketing application.
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Risk assessment and control meeting, in order to assess and control the post-marketing risks of the drug, before approving the new drug for marketing, to discuss the adequacy and controllability of the post-marketing risk control of the drug.
