Hong Kong's Chinese Medicine Regulations become more difficult to export Chinese patent medicines

Business Club December 7th Hong Kong's "Chinese Medicine Regulations" came into force, resulting in more than 5,000 Chinese patent medicines banned in Hong Kong, which has become a new layer of "nightmare space" under the downward trend of Chinese medicine exports.

The Hong Kong Government Food and Health Bureau stated that Hong Kong's "Chinese Medicine Ordinance" will take effect tomorrow (December 3rd). Unregistered proprietary Chinese medicines (including those manufactured in mainland China, Hong Kong and other regions) will be prohibited from selling in Hong Kong. Illegal or criminal liability.

A circulation company in Guangdong that engages in the import and export of pharmaceuticals told reporters that Hong Kong, as a bridgehead for the export of Chinese medicines, as an important reference place for consumption of Chinese medicines in various parts of the world, has suddenly tightened its access system for Chinese medicines, which will inevitably increase the export market for Chinese medicines in China. harsh.

The ban on sales rings the alarm bell

"Hong Kong's sale of Chinese medicine is a pass that is approved by the West. Its more rigorous product review system will allow more Chinese medicine manufacturers to look at it."

According to information from the Hong Kong Department of Health, as of October, there were a total of 16700 applications for registration, including 14,000 applications for transitional registration. According to Nandu's reporters in Hong Kong, there are currently 9,150 cases of transitional registration, 2,130 cases of formal registration, and 5,300 applications that failed to provide basic safety test reports on heavy metals, toxic elements, pesticide residues, and microorganisms. registered.

A spokesperson for the Hong Kong Department of Health spokesman said in an interview that the Department of Health issued the policy and the main concern is still drug safety. "We are mainly to ensure the quality of the medicine itself, so as to ensure the safety of medicines and the confidence of consumers."

The reporter was informed that in order to minimize the impact on the Chinese medicine industry, the Hong Kong Department of Health had already reserved a transition period. The Ordinance provides for Chinese patent medicines manufactured, sold or sold for sale in Hong Kong after March 1, 1999. It provides transitional registration arrangements for a certain period of time. It is illegal to sell, import or have unregistered proprietary Chinese medicine after December 3rd.

In the face of the failure of more than 5,000 drug applications, the Hong Kong Government stated that there is sufficient time for the industry to make preparations according to the legal requirements. It is believed that the unsuccessful application is because of unsatisfactory product test results, or "automatic abstention."

According to relevant statistics, most of these products come from the mainland. In Hong Kong, there are only a few hundred manufacturers of traditional Chinese medicines.

The relevant government departments reminded that all unregistered proprietary Chinese medicines will not be allowed to be sold in Hong Kong after the Ordinance comes into effect. If anybody finds sale, the Department of Health will follow up and verify and even be held criminally liable.

Yesterday, an industry source close to the exporter told Nandu that Hong Kong’s ban on the sale of pharmaceuticals was mainly due to “a basic safety test report on the failure to provide heavy metals, toxic elements, pesticide residues, and microbes during the application”. It is worth reflecting on the performance of drug inspection standards far above the Mainland.

It is understood that GMP certification is the primary condition for medicines to enter the international market, and the number of Chinese medicine companies passing GMP certification is very small. At present, there is still a lack of uniform standards in the cultivation, production, determination of active ingredients, toxicological efficacy testing, quality testing, and packaging and storage of traditional Chinese medicines in China.

Mainland supervision is referred to as extensive

At the same time, there is public opinion in the country that, in contrast to the new regulations in Hong Kong, the disclosure of Chinese patent medicines in the Mainland is not transparent enough, and it has become one of the reasons for the strict management of the Hong Kong government. There are allegations that the Hong Kong Government's refusal of thousands of applications for Chinese medicines is enough to explain that the mainland still has extensive management over the supervision of drug quality and safety.

According to industry sources, in the registration and approval of drugs, the Mainland standards should be “loose”. The source said that in 2005 alone, the Food and Drug Administration accepted 10009 new drugs for approval, while the US Food and Drug Administration received only 148 new drug approvals in the same period, of which only 136 were eventually approved. The excessively wide range of domestic Chinese medicine examination and approval standards and the excessive number of excessively used drugs have been criticized. Although China's drug registration and examination and approval have been tightening in the past two years, the overall situation is far from the "rigorous standards."

Hong Kong's "refusal" of some proprietary Chinese medicines also has the above factors. Some time ago, the pharmacy department's prudent “reminder” on Vitamin C Yinqiao Tablets and Phoenix Satellite TV’s exposure to the toxic and side effects of Longdanxiegan Wan, etc. exposed the quality and safety issues of Chinese medicines, and made people’s access to “rough Chinese medicine” internationally. The market expressed doubts.

The Hong Kong market is particularly critical

Does Hong Kong's severe drug administration point directly to the weakness of Chinese medicine manufacturing? The industry's answer is yes. It is understood that the issue of the Chinese medicine industry in China cannot be ignored. According to statistics, the annual trade volume of natural drugs in the world amounts to 16 billion U.S. dollars, China only has a 3.6% share, and most of them are raw material medicines and health care medicines; many of the medicinal herbs involved in the cultivation, processing, transportation, trade, preparation, and application of traditional Chinese medicines are involved. The field has not yet been effectively integrated; product standards are the major obstacle to the pace of internationalization of Chinese medicine. One not too old data is that as of January 2008, there were only 307 companies that obtained GMP certificates among more than 1,100 Chinese herbal decoction pieces. At present, there are more than 9,000 kinds of proprietary Chinese medicines that have been approved for listing in China, with approximately 58,000 approval numbers.

The relevant person of the State Food and Drug Administration has publicly told the media that the Mainland respects the laws and regulations of the Hong Kong Special Administrative Region on the administration of Chinese medicine. However, “the regulatory system of proprietary Chinese medicines will not undergo major changes.” The source said that the Bureau of Food and Drug Administration will continue to adhere to the supervision of Chinese medicine; the supervision will aim at achieving “safe, effective, and controllable quality” of medicines.

The Chinese government promulgated the "Approval Procedures for New Drugs" in November 1999 and also strictly stipulated the technical requirements for pharmacological, toxicological, clinical, quality standards, stability, reference substance and injection studies for new Chinese medicines.

According to industry insiders, Hong Kong's role as a bridgehead for the Chinese medicine industry will become increasingly apparent. Hong Kong is the largest exporter of Chinese patent medicines and the most important re-export of Chinese medicine to the world. The marketing environment of Chinese patent medicines in the Hong Kong market is extremely important to help Chinese medicines exploit the world market. Hong Kong has long been at the top of China's proprietary Chinese medicine exports. Hong Kong's Chinese medicine market trades in billions of Hong Kong dollars each year, of which half are used locally and the other half is re-export trade. The top four categories of Chinese medicines with an advantage in the international market are Southeast Asia, Japan and South Korea, Europe and the United States. In addition to the relatively strong affinity of the first two types of markets, Chinese medicines must first pass the FD A certification to enter the US market, making it the most difficult to enter, followed by Europe.