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Selection Skill of Injection Reference Formulation

Date: 2019-06-18
浏览次数: 46

On December 22, 2017, CDE organized the drafting of 'technical requirements for conformity assessment of  chemical generic drugs(injection)', and solicited public opinions.

The selection of reference formulation described in the 'draft' is as follows:


As a reference formula, the original research product should have complete and sufficient safety and effectiveness data as the basis for listing. If the above requirements are met, the enterprise is recommended to select the reference formula in the following order:


The original research drugs listed in the domestic market are preferred; if the original research drugs are not listed in the domestic market, the original research drugs listed in Europe, the United States and Japan should be selected (for multiple countries, it is recommended to select the approved products in the United States, the European Union and Japan). If the prescription of the original research drug listed in foreign countries is inconsistent, the applicant will evaluate according to the existing technical requirements and select a more reasonable original research drug.


When the original research enterprise stops production, it can choose the RS label drug on the American orange peel book.


If there is any doubt about the selection of the reference formulation (except for patent issues), it can be determined through discussion with the unified evaluation office of the Ministry of general affairs.


Combined with the principle of reference formulation selection for oral solid formulation, the reference formulation for injection is relatively clear and simple. Generally speaking, on the basis of meeting the requirements of safety and effectiveness, priority should be given to the original research drugs listed in China, including original research, original research and real estate; the second is to select the original research drugs abroad; stop the original research enterprises and select rs.

参比制剂

Selection skills


1. Make full use of the database of imported drugs and track their registration information when necessary.

2. According to the initial listing time, the original research enterprises will focus on the listing time of the United States, the European Union (Member States) and Japan.

3. The initial study will be mentioned in the 'development process' section of the IFS document.

4. Patent licensing, joint development, market licensing, etc. need to pay attention to differences, English: finder, penter, mark, etc.

5. It is necessary to clarify the relationship between enterprises, especially acquisition, merger, etc.

6. Refer to other companies' reference preparation information for reference preparation.


Common mistakes


1. The compounds in the original study are confused with the preparations in the original study.

2. Ignore the original R & D varieties.

3. XXX injection  should be distinguished from XXX injection.


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