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Cost & Time for Drug China NMPA Registration Approval(Clinical Trials Phase)

Tags: | NMPA | Pharmaceuticals | Drug | 药监局 | 医药品 | 药品 |

Phase B.  Clinical Trials Phase




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

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1-2 years

Bioequivalence /Pharmacokinetics Study & CRO Service Cost (for class 6 Generic Drug)

l Need 20-30 groups

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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.