2024年4月13日发(作者：)

中成药新药审批流程

1.新药申请材料齐全后，提交至国家药品监督管理局。

After the new drug application materials are complete,

they are submitted to the National Medical Products

Administration.

2.国家药品监督管理局收到申请材料后，进行初审。

After receiving the application materials, the National

Medical Products Administration conducts preliminary review.

3.初审通过后，进行专家评审。

After passing the preliminary review, expert evaluation

is conducted.

4.专家评审结论作为决定新药是否批准上市的重要依据。

The conclusion of the expert review serves as an

important basis for deciding whether a new drug is approved

for marketing.

5.若专家评审结论不一致，可能需要召开专家座谈会进行讨论。

If the expert review conclusion is not consistent, it may

be necessary to convene an expert seminar for discussion.

6.根据专家评审结论，国家药品监督管理局进行终审。

Based on the conclusion of the expert review, the

National Medical Products Administration conducts final

review.

7.终审通过后，国家药品监督管理局颁发新药批件。

After final approval, the National Medical Products

Administration issues the new drug approval.

8.新药批件的发放标志着新药批准上市。

The issuance of new drug approval marks the approval of

the new drug for marketing.

9.新药批准上市后，还需要进行药品生产许可和GMP认证等程序。