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E 5 (R1) Ethnic Factors in the Acceptability of Foreign ...
considerations for clinical trials (E8), and statistical considerations (E9). A guidance on the choice of control group in clinical trials (E10) is under development. 2.1 Additional Studies to Meet the New Region’s Regulatory Requirements When the foreign clinical data do not meet the regional regulatory requirements, the
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Guideline for good clinical practice E6(R2)
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Guideline for good clinical practice E6(R2)
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Guideline on good pharmacovigilance practices …
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Guideline on good pharmacovigilance practices …
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Guideline on good pharmacovigilance practices (GVP)
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Guideline on good pharmacovigilance practices …
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