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How to Choose, Record and Reference Formulation One-off Import?

Date: 2019-03-26
浏览次数: 69

1. List of reference formulation


The first step is to look at the list of reference formulations. So far, more than 1000 regulations have been promulgated in 18 batches.


2. Principles of selection and determination and what to record?


In short: those that are not published should be put on record, and only after the record is passed can they be used.


3. What is the filing of reference formulation?


Reference is made to the 'registration and recommendation procedures for reference formulations used to assess the consistency of the quality and efficacy of generic drugs


The manufacturer shall fill in the 'reference formulation record form' and the 'summary data', and shall specify the reasons for the selection of the reference formulation, submit the effective approval documents of the current production varieties, the first approval of the production products and the description of the historical evolution after the listing.

参考制剂一次性进口

4. What materials are prepared for reference formulation filing?


What is the content of the summary information?


1). Basic information of varieties to be evaluated

2). Evaluation suggestions on the history and current use of R & D varieties at home and abroad

3). List of domestic varieties to be evaluated

4). Conclusion of reference formulation selection

5). Other issues to be clarified

6). References

7). Attachment (copy of reference)

8). One-off import of reference formulation


Scope of application:


The control drug pair has been listed overseas but not in China.

It is also used for one of the following purposes


(1) Research for the purpose of Chinese drug registration;

(2) Evaluate the consistency of generic drugs;

(3) Narcotic drugs for clinical trials, excluding psychotropic substances and biological products

参考制剂一次性进口

Working procedure:


Applicant: pharmaceutical research and development institutions, pharmaceutical manufacturing enterprises or their authorized institutions


Application procedure: the applicant applies to the local bureau, and the Provincial Bureau shall organize the examination. The examination shall be conducted within five days after acceptance, and the result shall be given within 20 days after approval or disapproval


If the enterprise purchases the reference preparation products abroad, when submitting the consistency evaluation data, it shall provide the purchase voucher, product packaging, instruction and other information, or prove by other appropriate methods that the reference formulation used is the product of the enterprise.


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