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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

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

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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.

Etc.

 


Risky Food Export China Process
In China, the imported food is divided into 4 risk levels from low to high : A, B, C, D ; Different levels of supervision are adopted for foods with different risk levels;

The medium to high risky imported food categories include:Meat products, aquatic products, dairy products, sausage casings, bird nest products, bee products, egg products, edible oils and fats, oilseeds, stuffed wheaten products, edible grains, milled grain industry products and malt, fresh and dehydrated vegetables and dried beans, condiments, nuts and seeds, dried fruits, unroasted coffee beans and cocoa beans, foods for special dietary purposes, and health foods, Animal feed etc.

Dairy
Products

Meat
Products

Aquatic
Products

Animal
Feeds

GMO
Agriculturals

Dietary
Supplements

Infant
Formula

Fresh
Foods
More...

In addition to the above-mentioned general food import procedures, the risky imported food also need to go through other government procedures of Manufacturer Registration / Certifcation, Pre-market approval of the product etc.
 
The common China's government departments include :
Learn More China Pre-market Approval >>>
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