Stopping the influence of Chinese medicine extraction commissioned processing industry

Recently, the CFDA issued the “Announcement on Implementing the Regulations Concerning the Supervision and Administration of Chinese Herbal Extracts and Extracts”, requiring that starting from January 1 this year, all Chinese patent medicine manufacturers that do not have the ability to pre-process and extract Chinese herbs should stop production of the corresponding Chinese medicine varieties. , Overdue non-stop production will be strictly investigated and dealt with in accordance with the "Drug Administration Law"; at the same time, production and use of Chinese herbal extracts must be filed.

“The commissioning of Chinese medicine extraction commission processing has been stopped in the industry for a long time and is also in line with expectations. It has undergone a transitional period, and implementation on the ground is a matter of course and will not cause a 'big shock'.” Some industry sources said in an interview with our reporter. .

It is reported that, in response to the outstanding problems in the extraction process of traditional Chinese medicines, the competent authority issued and issued the Circular on Strengthening the Supervision and Administration of Extracts and Extracts from the Production of Chinese Materia Medica as early as July 2014 (Food and Drug Administration, Pharmaceutical Supervision, No. 135, 2014). No. 135) clarified the requirements for the management of extracts and extracts of Chinese medicines and stipulated the transitional period; in May 2015, the relevant notice on the special treatment of Ginkgo biloba leaves was issued, and relevant responsible persons also emphasized at relevant conferences since 2016. From January 1, the production of Chinese medicines can no longer be commissioned for extraction, and the purchased extracts must comply with regulations.

“It is forbidden to entrust the processing of Chinese herbal extracts to domestically-owned Chinese patent medicine companies. Since the current domestic plant extracts companies mainly export, the impact of stopping the entrusted processing of extracts of Chinese herbal medicines on the planting and lifting industry is not expected to be significant.” Chinese Medicines and Health Products Yu Zhibin, deputy director of the Department of Chinese Medicine of the Chamber of Commerce of the Import and Export Chamber of Commerce, believes that the state starts from the safety of the Chinese medicine industry. Because of the potential risks of the commissioned processing, the restrictive measures are intended to improve quality and control risks.

Production of herbal extracts must be recorded

Earlier, the responsible person of the competent department pointed out publicly that there are some outstanding problems in the extraction of Chinese medicines and the supervision of extracts of Chinese medicines. The main manifestations are as follows: First, some Chinese patent medicine companies do not have the ability to extract drugs, and the purchase of illegal extracts to produce drugs is difficult to guarantee quality. Second, related management systems are still not perfect, and there are still loopholes in corporate responsibility, regulatory responsibility, and qualitative punishment; Third, existing drug regulatory laws and regulations do not specify the regulatory attributes of Chinese herbal extracts, and the production and use of Chinese herbal extracts are not clear. Free in the entire process of drug quality supervision system.

From the industry perspective, on the one hand, due to the limitations of extraction equipment and technology, or limited production capacity, some Chinese patent medicine manufacturing companies rely on commissioned processing of Chinese medicine extraction; on the other hand, some professional Chinese herbal extract production companies do not have proprietary drug varieties, specifically Do the extraction. The phenomenon of extracting and purchasing extracts from the self-built workshops in the industry coexists, and a few companies neglect quality responsibilities, such as quality standards, quality control, and technical guidance.

The announcement made it clear that starting from January 1, 2016, the national drug standard prescriptions of the Chinese patent medicines were downloaded, and the Chinese medicine extracts with separate national drug standards were implemented for the record management.

In this regard, experts said that the "Chinese Pharmacopoeia" 2015 version of a list of "vegetable oils and extracts," including the clove basil oil, star anise oil, ginseng stems and leaves total saponins, including 47 varieties and approved by the competent authorities The standards for extracts of traditional Chinese medicines all belong to the category of extracts of traditional Chinese medicines, and the records are administered in accordance with the Regulations for the Administration of Filing of Extracts of Chinese Herbal Medicine (see the Annex to Document 135).

The reporter noticed that Circular 135 proposed that “Extracts for Chinese medicines will no longer be managed under the approval number, except for the active ingredients and effective parts of Chinese medicines approved under the new drugs. After the expiration date of the original approval number expired, the food and drug administrations of the provinces (autonomous regions and municipalities) will no longer accept their applications for re-registration.

The aforementioned experts stated that there are certain defects in the management of the original Chinese herbal extract approval number on the market. “For instance, most companies involved in Ginkgo biloba have approval numbers, but there are problems with the purchase and sale of documents, sources of confusion, and so on, so the approval number will be cancelled in the future.” Experts pointed out during the interview that after commissioned processing was stopped, China If the pharmaceutical company wants to continue production, it will either build its own workshop or stop production or file it. After filing, pharmaceutical production companies are bound to use companies and cannot be easily replaced. If quality problems arise, the source of liability can be determined very quickly.

Encourage pharmaceutical companies to build their own extraction workshop

Although some varieties of Chinese herbal extracts can be outsourced, considering that the current plant extraction industry is still far from the national requirements, there are industry experts suggesting that the best way is for pharmaceutical companies to build their own extraction plant. That is, in accordance with the production needs of the company's own production, standardize the extraction of traditional Chinese medicine production process, attach importance to the control of traditional Chinese medicine production process, establish strict quality control standards, and promote product standardization. In this way, not only can guarantee the uniformity of quality between batches of products, but also help improve the quality of products and avoid quality risks.

It is reported that before and after the transitional period, due to the hard regulations of “all Chinese patent medicine manufacturing enterprises that do not have the ability of Chinese medicine pretreatment and extraction to stop the production of corresponding Chinese medicine varieties”, many Chinese herbal extract production enterprises and use enterprises actively followed up. Give greater investment in the ability of extracting Chinese medicine. For example, the total investment of Heilongjiang Zhonggui Pharmaceutical is 160 million yuan. It mainly constructs new plants and production lines such as traditional Chinese medicine extracting workshops. After the production, it can extract 1,500 tons of Chinese herbal medicines including Chinese herbal medicines before it is processed; Kangyuan Pharmaceutical Group and Zhejiang University, etc. Invested 480 million yuan to design and build a new generation of Chinese medicine injections to extract and refine the digital chemical plant; Guangdong Nanguo Pharmaceutical also issued an announcement for equipment procurement for the Chinese medicine extraction workshop.