2017 annual analysis report on unqualified data of drug quality

Source: yaozhi.com 2018-03-20 directory 1 Top 10 of unqualified chemical enterprises 2 Top 10 of unqualified chemical varieties 3 Top 10 of unqualified chemical testing items 4 Distribution of unqualified chemical in provinces and cities 5 Distribution of unqualified chemical dosage forms 6 Statistics of unqualified biological drugs 7 Sampling range 8 Summary of inspection basis Introduction: throughout the 2017 annual analysis report on unqualified drug quality data, the proportion of various drugs is shown in the figure below Among the 4106 batches of substandard drugs (excluding 654 batches of counterfeit products), it is worth noting that, in addition to the large proportion of traditional Chinese medicine and proprietary Chinese medicine, there are 493 batches of substandard chemical drugs and 2 batches of biological preparations The domestic drug market has been making great efforts in the supervision and inspection of traditional Chinese medicine In addition, many links in the production and market circulation of traditional Chinese medicine are not mature, so there will be more problems There are still such a large proportion of unqualified data in the mature chemical drug market, which is worth thinking about In addition, as a new hot biological drug, it should also be concerned In this paper, the unqualified data of traditional Chinese medicine, Chinese patent medicine, drug packaging materials, auxiliary materials and other types will be eliminated, and the unqualified data of chemical medicine and biological medicine in 2017 will be further analyzed to form this report for your reference The author will summarize and analyze the unqualified situation of chemical and biological drugs in 2017 from six aspects 1 There are 493 batches of top 10 substandard chemicals in total, and 151 batches (about 31%) are top 10 enterprises In addition, the top three "Guangxi chunzhengtang Pharmaceutical Co., Ltd.", "Guangdong Hongying Technology Co., Ltd." and "China Resources Shuanghe Pharmaceutical Co., Ltd." also appear in the top 20 ranking table (by batch) of total drug unqualified enterprises 2 According to the statistics of top 10 unqualified chemical drugs, the number of unqualified chemical drugs in the top 10 is 170 batches, accounting for about 34% of the total unqualified chemical drugs "Chloramphenicol eye drops" topped the list, with 41 batches in total, and Guangdong Hongying Technology Co., Ltd accounted for 23 batches (see the figure below for details) 3 Top 10 unqualified chemical testing items The analysis of unqualified chemical test items shows that chemical quality problems are mainly manifested in [content] (unqualified 97 batches), [relevant substances] (unqualified 93 batches), [dissolution] (unqualified 55 batches), etc.; according to the frequency of unqualified announcement, the unqualified chemical test items TOP10 are shown in the figure below 4 Distribution of substandard drugs in provinces and cities in 2017 the announcement of substandard drug preparations came from CFDA General Administration and 26 provinces and cities No such announcement was made in Beijing, Heilongjiang, Hunan, Liaoning, Ningxia, Qinghai, Tibet and Inner Mongolia In the distribution of provinces and cities, Guangdong Province published the most unqualified pharmaceutical preparations, 102 batches in total, accounting for 21%; other provinces and cities are relatively few, less than 100 batches The State Administration issued the most such announcements, 161 batches, accounting for about 32%, which shows its inspection strength Distribution of substandard drugs in various provinces and cities 5 Distribution of substandard drug forms pharmaceutical preparations include multiple forms, and the drug regulatory bureau has no restrictions on the forms of the drugs sampled In 2017, the unqualified drug types include tablet, capsule, injection, granule, plaster, lotion, powder, oral liquid, nose drops, syrup, eye drops, powder spray, etc Among them, tablets, injections, granules, eye drops and capsules are conventional dosage forms, accounting for 32%, 27%, 12%, 10% and 8% of the total unqualified drugs respectively The specific situation is shown in the following figure: distribution of unqualified dosage forms 6 The statistics of unqualified biopharmaceuticals are less In 2017, only two batches of Bifidobacterium triple viable capsules were found unqualified, indicating that the manufacturer is "Shanghai Xinyi Pharmaceutical Co., Ltd." and the unqualified test item is the determination of the number of viable bacteria The main reasons why the number of unqualified biological preparations is small are as follows: ① the number of biological preparations used as sampling samples is relatively small; ② the development of biological products started late, and the relevant standards are less or imperfect, which to some extent limits the judgment of their quality For example, in the 2015 edition of the Chinese Pharmacopoeia, there are 2598 varieties in the first part, 2603 varieties in the second part, and only 137 biological products in the third part 7 Sampling range The varieties supervised and sampled by each drug regulatory bureau basically focus on the following aspects: the varieties with large dosage, wide clinical use, more production enterprises, the varieties with large dosage and unstable quality, the varieties with high unqualified rate in inspection, the varieties with illegal drug advertisements, the varieties with high risk, the unqualified varieties announced by other provincial bureaus, and the varieties with more adverse reactions These types are more likely to be sampled than other types The sources of drugs are mainly concentrated in production enterprises, business enterprises and users 8 The inspection basis is mainly based on the Chinese Pharmacopoeia, including the national drug single page standard, the preparation standard of local medical institutions, the standard issued by the Ministry of health, the national standard upgraded from landmark, the supplementary inspection method and approval document of inspection items for drug inspection, and the Chinese biological product regulations Summary: chemical drugs are the most widely used drugs and biological drugs are the most popular drugs They play an extremely important role in the drug market, so their safety and effectiveness are very important In order to further ensure the quality and safety of drugs, it is necessary to grasp the drug quality from the root, the simultaneous development of drug quality and drug standards Of course, it's a long way to go We should continue to seek and practice Disclaimer: the statistics are only from the official website of food and Drug Administration of each province The small edition has eliminated counterfeit drugs and duplicate data marked by the food and drug administration, but there may still be counterfeit drugs that have not been found by relevant departments Due to the continuous update of official website data, there will be slight deviation in the statistical results for reference only Appendix: tips on drug safety consumption (1) The food and Drug Administration reminds consumers to purchase drugs in legal and regular medical institutions and pharmacies and ask for relevant documents for preservation; when purchasing drugs, they should pay attention to check whether the relevant marks of the outer packaging, such as the production date, validity period, manufacturer, approval number, are complete and within the validity period; when necessary, they can log in the relevant website to check the drug registration phase Relevant information: after purchasing the drugs, keep the drugs according to the storage conditions indicated in the instructions, and take the drugs according to the doctor's orders or usage, paying special attention to the adverse reactions, taboos, precautions and other contents in the instructions (2) Access to drug information ● website of State Food and Drug Administration (CFDA) ● website related to drug intelligence data