Recently, the reporter learned that the US Food and Drug Administration has included two Chinese pharmaceutical companies on the import warning list. According to incomplete statistics, since 2009, 40 Chinese pharmaceutical companies have appeared on the US Food and Drug Administration's import warning list. Industry insiders pointed out that with the implementation of the generic drug consistency evaluation policy, the export of preparations will account for a larger and larger share of the company's revenue in the future. Big hit.

Pharmaceutical companies frequently appear on the warning blacklist

Recently, the U.S. Food and Drug Administration placed Xinxiang Pharmaceutical Co., Ltd. and Xinxiang Tuosheng Chemical Co., Ltd. on the import warning list. All drugs and APIs (such as adenosine, choline, uridine, and other pharmaceutical intermediates) produced by these two companies will be subject to "detain without inspection" by U.S. Customs when they are exported to the United States, which means that The products of these two pharmaceutical companies are banned from exporting to the United States. It is understood that the two pharmaceutical companies were banned by the US Food and Drug Administration due to non-compliance with GMP (that is, Good Manufacturing Practices) on-site inspections.

A reporter from Beijing Business Daily saw on the official website of Xinxiang Pharmaceutical Co., Ltd. that the company established Tuoxin Group with Xinxiang Tuosheng Chemical Technology Co., Ltd. in early 2005. Many of its subordinate products have reached the standards of the US Pharmacopoeia and the European Pharmacopoeia. It has been sold to more than 20 countries and regions in America, Europe, Southeast Asia, etc., and an international marketing network has been initially formed. A reporter from Beijing Business Daily tried to contact the relevant person in charge of the company to inquire about the details of the ban on drug export, but the call was never answered.

In fact, it is not an exception for Xinxiang Pharmaceutical Co., Ltd. to be on the "blacklist" of the US Food and Drug Administration. In March last year, the US Food and Drug Administration found that the production of APIs seriously deviates from CGMP standards ( International GMP standards), including the phenomenon of untimely recording of laboratory data. At the same time, in 2012-2014, Hisun Pharmaceutical had a large number of customer complaints about insufficient content and excessive impurities, but the original data have been deleted. In response to the inspection results, the U.S. Food and Drug Administration entered the import warning list of 13 APIs of Hisun Pharmaceuticals. It is understood that the actual sales revenue of these 13 varieties of APIs in the US market from January to August 2015 was 177 million yuan, and the original sales revenue in the US market from September to December 2015 was expected to be 62 million yuan. In the first half of last year, Hisun Pharmaceutical's net profit fell by 78.33% year-on-year.

Two monitoring points

Since 2009, 40 Chinese pharmaceutical companies, including well-known pharmaceutical companies such as Kyushu Pharmaceuticals and China Resources Sanjiu (22.70, 0.00, 0.00%), have appeared on the US Food and Drug Administration's import warning list. It is worth noting that most of these companies export raw materials and generic drugs to the US market, and these two categories have also become the monitoring points of the US Food and Drug Administration in recent years.

Since China has now become the second largest importer of APIs in the United States after India, more and more Chinese pharmaceutical companies are applying for APIs in the United States. However, the long-term export experience does not allow enterprises to obtain a relatively relaxed regulatory atmosphere. Since last year, the US Food and Drug Administration has greatly increased the number and frequency of inspectors for China's GMP API production bases, and heavy blows have appeared frequently. In January this year, the listed pharmaceutical company Haixiang Pharmaceutical (10.17%, 0.00%, 0.00%) of the raw materials in the Waisha plant was found to have insufficient laboratory data integrity when inspected by the US Food and Drug Administration. Cannot enter the US market.

According to industry insiders, the "insufficient laboratory data integrity" mentioned by the US Food and Drug Administration is also a common problem in the vast majority of "banned" Chinese pharmaceutical companies. According to the results of on-site inspection of Chinese pharmaceutical companies by the United States and the European Union last year, the main problems are at the data level, including incomplete data, inaccurate data, fraudulent analysis reports, replacement of records, re-copying of records, inconsistency between dates and signatures, etc. .

Generic drugs are another major point of overseas supervision. In January last year, domestic pharmaceutical companies such as Xiantai Pharmaceutical, a subsidiary of North China Pharmaceutical (6.940, 0.00, 0.00%), and Zhejiang Prokangyu, a subsidiary of Puluo Pharmaceutical (6.73, 0.00, 0.00%), were found to have fraudulent documents. Such problems failed to pass the EU GMP inspection, and the product also lost the opportunity to enter the EU market. 

Regulations will be tightened

"With the introduction of the generic drug consistency policy, the US and European Food and Drug Administration's supervision of Chinese companies will be further tightened." Shi Lichen, head of Beijing Dingchen Pharmaceutical Consulting, told the Beijing Business Daily reporter that currently exported drugs are in The proportion of business of many enterprises is very small, probably less than 10%. However, after the official implementation of the generic drug consistency evaluation policy, the proportion of business occupied by exports will increase significantly. If the company is sanctioned by the United States and the European Union due to its own problems at this time, the performance of pharmaceutical companies will be greatly affected.

It is understood that there are nearly 5,000 pharmaceutical companies in my country, of which more than 90% are generic pharmaceutical companies. This year, the state has stepped up efforts to adjust the generic drug industry. Now, the "Draft for Comments" on generic drugs has been issued, which requires generic drugs to be consistent with the original drugs in terms of quality and efficacy in the future. Industry insiders predict that the export of generic drugs may account for more than 30% of the revenue of preparation export companies in the future. If the quality of drugs can be guaranteed, then this policy will undoubtedly be beneficial for enterprises. However, if there is a problem with the quality of the drug and it is "closed" by the US Food and Drug Administration, then the pharmaceutical company will face a big blow

Shi Lichen pointed out that now the US Food and Drug Administration's monitoring of Chinese APIs and preparations has changed from random inspections to routine inspections. In addition, inspections of the production processes of Chinese companies are also being strengthened. As the U.S. Food and Drug Administration tightens its supervision, other countries will follow suit and increase inspections on Chinese APIs and preparations. The result of the above three points is that pharmaceutical companies that "go out" will face more stringent inspections, and those that fail to "go out" will have more difficulty in "going out". For example, it will be more difficult for production lines to obtain FDA certification. If Chinese pharmaceutical companies want to go abroad smoothly, on the one hand, they must strictly abide by every requirement of GMP, and at the same time strengthen the research and development of independent innovative drugs that are still in the blue ocean state. On the other hand, it is also a wiser choice to build factories, mergers, and acquisitions in the United States, as well as to build our own R&D institutions and marketing channels.