289 evaluation of the consistency of the domestic special varieties in the catalogue, only when there is a group, can there be a play?

Source: minenet 2018-03-02 on January 30, 2018, CDE released the list of 19 domestic unique varieties in the generic drug consistency assessment 289 base drug catalog, and prompted enterprises to implement the main responsibility for the evaluation of domestic unique varieties, speed up the evaluation work, evaluate according to the specific situation of varieties and relevant requirements, put forward scientific and reasonable evaluation scheme, and communicate with CDE in time CDE will also increase its support and service to the evaluation of domestic unique varieties of enterprises, organize expert consultation according to the research situation of varieties, timely solve the problem of uncertain technical standards in the evaluation scheme, and jointly accelerate the consistency evaluation of domestic unique varieties with enterprises Two major requirements in the policy need to pay attention to the development of clinical trials: according to CFDA's guidance on the classification of generic drugs for conformity assessment of quality and efficacy (No 49 document in 2017), Article 6 stipulates that "for domestic specific varieties, enterprises can choose to conduct clinical trials again to prove their safety and effectiveness" Time limit for consistency evaluation: in the opinions on the quality and efficacy consistency evaluation of generic drugs issued by the general office of the State Council on March 5, 2016, it is required that the consistency evaluation should be completed by the end of 2021 for the varieties that need to carry out clinical effectiveness tests and have special circumstances Based on the above contents, i.e clinical trials are required for domestic specific varieties, and the time limit for completing the consistency evaluation is at the end of 2021 19 domestic unique varieties, involving hundreds of pharmaceutical enterprises, 19 domestic unique varieties, all specifications involving 1590 approval numbers, involving hundreds of pharmaceutical enterprises 19 domestic specific varieties were listed or collected in the legal standards earlier, for example, thyroid tablet was first collected in the Pharmacopoeia of 1953, compound aluminum hydroxide tablet, Compound Glycyrrhiza tablet were first collected in the Pharmacopoeia of 1963, anisodamine hydrobromide and injection, compound medestrone acetate tablet were first collected in the Pharmacopoeia of 1977, Berberine hydrochloride tablet, biphenyl diester tablet, and racemic anisodamine Alkali and compound reserpine tablets were all listed in the 1980s, and other varieties were also listed in the 1980s and 1990s These varieties have decades of clinical application basis, with good clinical efficacy, and most of them are still widely used up to now, such as berberine hydrochloride tablets, Compound Glycyrrhiza tablets, biphenyl diester tablets and dropping pills, huperzine A tablets and capsules, anisodamine hydrobromide tablets, fufanglixueping aminophenetidine tablets, etc After searching CFDA official website, no adverse reactions of the above-mentioned special varieties were reported In addition, other databases such as CNKI were searched, and only adverse reactions of a few varieties (such as biphenyl diester) were reported No adverse reactions of other varieties in clinical application were reported The above-mentioned domestic special varieties have better safety in clinical application for decades There are two kinds of Chinese unique varieties, one is the first active ingredient found in our country, such as huperzine A, biphenyl diester, racemic anisodamine and anisodamine hydrobromide, which have obvious activity through pharmacological research and are developed into drugs for clinical treatment For example, huperzine A has the activity of improving memory and symptoms of dementia patients Although berberine hydrochloride was first listed in Japan, it has been widely used in China because of its abundant resources, and it has anti-inflammatory activity comparable to antibiotics Another kind of Chinese and Western medicine compound preparation, such as compound aluminum hydroxide tablet, Compound Glycyrrhiza tablet, compound reserpine aminopteridine tablet, compound naphthoquine phosphate tablet, combines the action characteristics of chemical drugs and traditional Chinese medicine to extract active ingredients, and has various therapeutic effects on related diseases, such as compound aluminum hydroxide tablet to inhibit stomach acid and relieve stomach spasm and pain, Compound Glycyrrhiza tablet to relieve cough and dispel cough Phlegm effect and compound reserpine and triamtetradine tablets contain diuretics and vasodilators to treat mild to moderate hypertension In view of the clinical application foundation of the above varieties for decades, and they are still widely used, the author suggests whether the clinical safety and effectiveness evaluation can be properly simplified through the analysis and summary of the existing clinical application Difficulties and solutions in 19 varieties, except for a few varieties (such as anisodamine hydrobromide tablets, nilestriol tablets), most of the other drugs are relatively cheap, and the profits of the manufacturers are relatively small Because there is no reference preparation, 120 pairs of clinical trials need to be done At present, the cost of such clinical trials is about 10 million yuan, and the cost of pharmaceutical research is 3-4 million yuan Except for the relatively strong enterprises, ordinary small and medium-sized enterprises are unable to bear such research and evaluation costs The author suggests that, for 19 unique domestic varieties, whether the pharmaceutical industry association can take the lead in organizing pharmaceutical enterprises with evaluation willingness to participate in the consistency evaluation research of these unique varieties, entrust relevant pharmaceutical research units to further study the listed prescription technology and standards of the same variety, unify the prescription technology and quality standards, and carry out clinical safety and effectiveness test on this basis After the consistency evaluation is passed, the participating enterprises carry out the production according to the unified prescription process and quality standard formulated by the re evaluation to ensure the quality The pharmaceutical supervision department strengthens the daily supervision and inspection, so that the unique domestic varieties can pass the consistency evaluation smoothly, and continue to play a better role in the clinical treatment 。