The process of the survival of genericdrugs will be accelerated.
Today (28 March), the State Drug Administration issued new rules for the selection and confirmation of generic drug reference preparations to further standardize the review and consistency evaluation of generic drugs, optimize working procedures and strengthen service guidance.
Under the new rules, chemical generic sorority preparations will be selected according to three principles.
The order of selection of the original research drugs is in order: the original research drugs listed in China, the drugs produced by the foreign original research enterprises produced in China or produced by technology transfer, and the original research drugs that have not been imported.
Original research drugs refer to the first domestic and foreign approved market, and has complete and adequate safety, validity data as the basis for listing drugs.
In cases where the original drug is discontinued or is not suitable as a reference formulation due to quality and other reasons, the internationally recognized drug of the same kind, which is produced in China by audit or determined by audit, or is transferred through technology, may be selected in the countries with regulatory norms such as the United States, Japan or the European Union.
The internationally recognized generic drug is a generic drug that is approved for marketing in the United States, Japan, or the European Union and has been granted the status of a reference formulation.
Other drugs that have been evaluated by the State Drug Administration for safety, effectiveness and quality controllability.
There are two types of selection methods, enterprise and trade association application and drug examination center recommendation.
In terms of time limits, after the application of the pharmaceutical production and research and development enterprise or trade association in accordance with the three principles mentioned above, the drug review center (CDE) drug of the State Drug Administration shall reply within 60 working days. China is a large country of generic drugs, the current domestic drug more than 160,000 batches, generic drugs still occupy a dominant position. These drugs are also the main body of clinical use.
In recent years, through the new classification of chemical drugs registration, as well as the consistency evaluation of generic drugs and other policies, the quality of generic drugs in China is constantly improving, in the process, drugs that can not meet the new standards will also be eliminated.
However, in this process, the selection and confirmation of the reference preparation is of great importance. Reference preparations, that is, generic drugs, are listed and have a complete clinical data chain of new drugs, is a number of prescription process reasonable, stable quality, the exact efficacy of drugs. Choose different drugs as reference preparations, the efficacy is quite different.
In principle, the original medicine should be chosen as the reference preparation, but due to historical reasons, the choice of reference preparation sparing drug in China is more difficult. In the consistency evaluation of the "289 catalog" varieties, which has been carried out in large numbers, there are problems such as the inconsistency between a large number of drug dosage forms and primary drugs.
There have even been cases of 43 azithromycin production enterprises collectively selecting the wrong reference preparations, which has affected the progress of the consistent evaluation of the relevant enterprises. It can be seen that in the new reference preparation selection and confirmation rules, the doubts about the reference preparation have been specified in detail, and the Time Limit for CDE feedback is set.
If the enterprise encounters major technical problems in the selection and confirmation process of the reference preparation, it can also communicate with the CDE in accordance with the relevant regulations.
On this basis, the listing of generic drugs in China and the process of passing consistent evaluation will continue to accelerate. In conjunction with the registration link of "the new registration classification of chemical drugs approved before the implementation of the list of generic drugs including essential drug varieties, since the first varieties through the consistency evaluation, other pharmaceutical production enterprises should in principle complete a consistency evaluation within 3 years", as well as the procurement link of the "

For the same varieties of drugs through the consistency of the evaluation of more than 3 production enterprises, in the centralized procurement of drugs, etc. , in principle, no longer choose varieties that have not passed the consistent evaluation", analysts pointed out that can not be timely high-quality generic drugs will be eliminated.