Consistency evaluation
1970-01-01 08:00:00
Detailed introduction
Generic consistency evaluation
1 background information
1) in February 6, 2016, the State Council promulgated the State Council [2016] document No. 8, "the general office of the State Council regarding the development of generic quality and efficacy evaluation of consistency of opinion", followed by countries in a short period of time has promulgated a series of relevant documents and guidelines on the consistency of the evaluation of generic drugs, really kicked off quality the curative effect and the consistency of the evaluation of generic products.
2) according to the requirements of national generic conformance assessment policy and time limit, 289 kinds of basic drugs required to complete the assessment at the end of 2018, the other generic product could become the "first name" or "top three" of the market and the economy is of great significance. Otherwise, there is a greater risk of losing market even number.
2 understanding and suggestions of Guizhou Middle Bay
Although the country has put forward clear requirements of the time and the principle of evaluation, but the regulations are not specific, enterprises in a dilemma. Guizhou jonby regulatory company has long been engaged in research work experience based on our understanding of the requirements are as follows:
1) do not rely on, active research.
2, we should pay more attention to the information review and arrangement of products, pay attention to the overall planning of generic drug evaluation, and lay the foundation for the research work.
3) attach importance to pharmaceutical research.
The focus of the research is the pharmaceutical part, but also the important content of the national evaluation of the quality of generic drugs, CMC is the most important, must advance.
4) time pressing
Generic consistency evaluation, especially the evaluation of basic drugs look like there are more than 2 years, after the actual decomposition of the time left to the enterprise has been very tight, even if all the smooth need 20-25 months.
5) carried out step by step.
The consistency evaluation of generic drugs is a comprehensive project with long chain and high cost. Especially in the early years to complete the registration of the product, registration research and reporting information is more weak, suitable for the first preliminary exploration of the product quality of the status quo to conduct a systematic and in-depth study.
6) the consistency evaluation of generic drugs should be divided into four stages
Phase of work
The first phase of the initial strategy and plan
Strive for expert and official opinion, determine strategy and plan
Select and record reference drugs
The second stage pharmaceutical equivalence study
Two possible development of the formula and process
New quality standards and process validation
Research and application of third phase BE exemption
Determining applicable BE research methods
BE research program and BE research record
Perform BE research
Fourth stage submission and review
Review, review, supplement and approval of 3 Guizhou Middle Bay advantage and performance
Generic conformance assessment work is a system engineering, need to complete the service chain and the allocation of resources, including CMC, GLP, laboratory animal research laboratory BE clinical experimental base, biochemical analysis and laboratory registration service team, as well as public good resources, and each link will have experienced technical team and perfect the quality management system, to withstand the on-site inspection and clinical inspection site registration. Guizhou has the advantages of shellfish consulting includes the following aspects:
CMC, the establishment of a National Research Laboratory of high level configuration, has a professional R & D personnel and more than and 10 years experience in drug development, one of the three major platform into China pharmaceutical technology research,
GLP, cooperative animal laboratory, canine animal test is not a problem;
In the group with BE, clinical trials and laboratory biochemical analysis base through FDA audit
18 years of experience, the registration team, easy to resolve technical problems.
18 years, experienced GMP team of consultants to help pharmaceutical companies improve GMP system, provide a guarantee for the stability of the process.
CMC study
, so far, has completed the research and development of 1-6 chemical agents varieties were more than 30,
By this, other project preparation group or enterprise commissioned technical services
Currently, the research preparation varieties are a class of drugs
The application, preparation related patents
BE test
FDA BE, more than 50 research experience
1, a EMA BE study experience
CFDA BE, more than 20 pre experiment and formal experiment
Project experience (part of the project signed in 2016)
, quetiapine fumarate tablets
, solifenacin material piece
, Adefovir Dipivoxil Tablets
, Paroxetine Hydrochloride Tablets
, levetiracetam
4 we are able to provide services
1 BCS classification and determination of effective components of products
(2) the selection of reference preparation and filing
3. Comparison of dissolution and dissolution curves of products and reference preparations in vitro
4 study on the solubility and permeability of BCS class I and III products
5. Study on bioequivalence based on BCS classification
6 formulation and process development of generic drugs
Prescription preparation and reverse engineering of reference formulations
Generic prescription adjustment and process development
Generic process identification and transfer
• process validation for three batches of pilot products
Establishment and analysis of generic quality standards
(7) application for bioequivalence exemption
Data analysis and judgment
• high permeability data and documentation to support material collection and collation
Provide and analyze the dissolution curve
• BE exemption policy, data preparation and submission
• tracking and supplement of BE exemption application review process
8) consistency evaluation involves the need for additional research in animal testing
9) BE test
• BE test strategy formulation and program drafting
Personnel recruitment and testing
Development and validation of methods for biochemical analysis
Biochemical analysis
Clinical trial data statistics and analysis
• BE registration data collection and submission
10) consistency review and approval
• review and approve process tracking
Review and supplement