Tags: | NMPA | Pharmaceuticals | Drug | 药监局 | 医药品 | 药品 |
Phase B. Clinical Trials Phase:
ITEM
COST (USD)
TIME
Traditional 4 phase Clinical Trials & CRO Service Cost
(for Class 1-2 new drugs)
l Phase I: need 20-30 groups
l Phase I I: need 100 groups
l Phase I I I: need 300 groups
l Phase I I I I: need 2000 groups
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2-5 years
Random verification Clinical Trials & CRO Service Cost
(for Class 3-5 drugs)
l Need 100-120 groups
1-2 years
Bioequivalence /Pharmacokinetics Study & CRO Service Cost (for class 6 Generic Drug)
l Need 20-30 groups
0.5-1 year
ll Many factors affect the cost and time of clinical trials, for example:
1. The complexity of the clinical trial program operations, complex or simple
2 The risk of clinical trial, high risk or low risk
3 The incidence of disease cases, common diseases or rare diseases.
4 disease cases occurred, is a national disease, or endemic disease.
5 the number of clinical trial centers, single or Multi-center trial
6 Clinical Trials hospital grade, senior hospital or general hospital, public hospitals or private hospitals
7 clinical trial center position, in the center of the city, or outlying cities
8 Standard Reagents price of the control groups.
Etc.