The new pharmacopoeia, press the industry high-quality development acceleration key


Release time:

2020-08-03

"The new pharmacopoeia has revised the quality standards of more than 200 Chinese herbal pieces, and we will adjust the company's internal standards according to the new pharmacopoeia." Recently, in an interview with reporters, Jiang Gan, the quality control department of Chongqing Chinese Herbal Pieces Factory Co., Ltd., said.

"The new pharmacopoeia has revised the quality standards of more than 200 Chinese herbal pieces, and we will adjust the company's internal standards according to the new pharmacopoeia." Recently, in an interview with reporters, Jiang Gan, the quality control department of Chongqing Chinese Herbal Pieces Factory Co., Ltd., said.

According to Ou Lingyun of the Quality Control Department of Ruiyang Pharmaceutical Co., Ltd., the new pharmacopoeia standards have been improved a lot, and its promulgation and implementation will put forward new requirements for the company's raw material procurement, product production, and inspection.

On July 2, the new pharmacopoeia was officially promulgated and officially implemented on December 30. It is reported that the new version of the Pharmacopoeia has made new progress in the collection of varieties, the implementation of the concept of drug life cycle management, the improvement of the drug standard system, the strengthening of drug safety and effectiveness control, the expansion of the application of mature analysis and testing technology, and the strengthening of coordination with international drug standards.

The industry believes that the promulgation and implementation of the new pharmacopoeia has pressed the acceleration key for the high-quality development of China's pharmaceutical industry.

According to Ou Lingyun of the Quality Control Department of Ruiyang Pharmaceutical Co., Ltd., the new pharmacopoeia standards have been improved a lot, and its promulgation and implementation will put forward new requirements for the company's raw material procurement, product production, and inspection.

On July 2, the new pharmacopoeia was officially promulgated and officially implemented on December 30. It is reported that the new version of the Pharmacopoeia has made new progress in the collection of varieties, the implementation of the concept of drug life cycle management, the improvement of the drug standard system, the strengthening of drug safety and effectiveness control, the expansion of the application of mature analysis and testing technology, and the strengthening of coordination with international drug standards.

The industry believes that the promulgation and implementation of the new pharmacopoeia has pressed the acceleration key for the high-quality development of China's pharmaceutical industry.

speed up the elimination of backward

Data show that as of the end of November 2018, there were 4441 API and preparation manufacturers nationwide. Not long ago, the U.S. Pharmaceutical Manager magazine published a list of the top 50 global pharmaceutical companies in 2020. Of China's more than 4000 pharmaceutical companies, only four entered the list: Yunnan Baiyao, China Biopharmaceuticals (the parent company of Zhengda Tianqing), Hengrui Pharmaceuticals, and Shanghai Pharmaceuticals.

To promote the high-quality development of the pharmaceutical industry, we must first start from the elimination of backward products. The Chinese Pharmacopoeia is the core of the national drug standard system. Which varieties it contains and what conditions these varieties must meet will undoubtedly have a guiding effect on the entire industry.

It is reported that the total number of varieties in the new pharmacopoeia has reached 5911, an increase of 5.5 compared with the 5608 varieties in the 2015 pharmacopoeia. However, the reporter learned that the new pharmacopoeia is not blindly expanding the variety of collections. Of these 5911 species, 319 species were actually added, 3177 species were revised, 10 species were no longer collected, and 4 species were adjusted and merged.

"The new pharmacopoeia variety collection is to adhere to the clinical demand-oriented, to ensure the safety and effectiveness of drug use as the goal." The relevant person in charge of the National Pharmacopoeia Committee said.

Taking the second part of the new pharmacopoeia as an example, the second part contains 2712 kinds of chemical drugs, of which 117 kinds are added and 2387 kinds are revised. According to the person in charge of the Chemical Drug Standards Department of the State Pharmacopoeia Commission, the second part of the new pharmacopoeia adheres to the selection principle of "clinical use, definite curative effect, safe use, mature technology and controllable quality". Only through the improvement of national drug standards, the content of the standard text is relatively perfect, and the varieties selected and approved by the medical professional committee and the pharmaceutical professional committee can be included in the new pharmacopoeia. For example, among the multiple dosage forms of the hypoglycemic drug voglitose, tablets, capsules, dispersible tablets and chewable tablets, only tablets and capsules are included in the new pharmacopoeia, and dispersible tablets and chewable tablets are not included due to doubts about the rationality of the dosage form.

At the same time, the new pharmacopoeia further expands the collection of varieties in the national essential drug list and the national basic medical insurance drug list, also increases the collection of varieties of commonly used pharmaceutical excipients in preparation production, and timely collects the first newly listed varieties such as conbercept, an anti-vascular endothelial growth factor receptor antibody fusion protein for fundus macular lesions and inactivated polio vaccine (Vero cells), which are independently innovated in China.

Lifting safe and effective

"We have been very concerned about the revision of the new pharmacopoeia. The new pharmacopoeia is indeed, as the industry says, reflecting the 'most rigorous standards', such as the requirements for the detection of pesticide residues in Chinese medicine varieties, the establishment of fingerprints and other methods to control the quality of Chinese herbal medicines (Chinese herbal extracts) such as Notopterygium and ginkgo biloba; the requirements for genotoxicity testing of some chemical varieties and so on." A relevant person from the Quality Control Department of CSPC told reporters that this requires companies to have corresponding quality control methods and testing capabilities, and at the same time actively seek breakthroughs to improve quality, and accelerate process improvement and product upgrading.

According to reports, the new version of the Pharmacopoeia implements the development concept of "people-centered", strengthens the safety and effectiveness of drugs, and makes every effort to safeguard the safety of public drug use.

Tu Pengfei, a professor at the School of Pharmacy of Peking University and chairman of the Chinese Medicinal Materials Committee of the State Pharmacopoeia Commission, said that in order to improve the safety and effectiveness of traditional Chinese medicine, the new version of the Pharmacopoeia has formulated 33 kinds of prohibited pesticide residues and arsenic, mercury, lead, and cadmium in plant Chinese medicinal materials and decoction pieces. Consistency limit guidelines for 5 heavy metals and harmful elements including copper. At the same time, in view of the current problems in the processing, processing and storage of Chinese herbal medicines and decoction pieces, the limit requirements for aflatoxin are increased for five Chinese herbal medicines that are easy to mildew, such as hive and earth beetle, and the limit requirements for zearalenone are increased for coix seed. The new edition of the Pharmacopoeia also comprehensively supplements, revises and improves the quality standards of decoction pieces. According to the transformation of effective ingredients in the process of processing, the detection indexes and content limits of raw and processed products are respectively formulated for the "raw and cooked" decoction pieces of traditional Chinese medicine, such as rehmannia glutinosa, fried bitter almond, and bitter almond.

"In terms of chemical drugs, the new version of the Pharmacopoeia has revised and improved the control requirements for impurities such as related substances in 150 varieties. At the same time, it has strengthened the control of genotoxic impurities and elemental toxic impurities, and further expanded the application of new technologies and methods. In addition, the new pharmacopoeia also reflects the results of the consistency evaluation of the quality and efficacy of generic drugs, fixing the good things in the consistency evaluation, and making the standards more scientific and rigorous." Tu Jiusheng, a professor at China Pharmaceutical University and director of the Standards Working Committee of China Chemical Pharmaceutical Industry Association, said.

Ma Jing, deputy secretary-general of the China Pharmaceutical Packaging Association, also said that in accordance with the principle of "overall planning and step-by-step promotion", the new pharmacopoeia has added 16 general testing methods for pharmaceutical packaging materials and further expanded the standard system for pharmaceutical packaging materials in the pharmacopoeia.

Boost products to sea

"One of the highlights of the new pharmacopoeia is the strengthening of the coordination of the international pharmacopoeia, which continues to strengthen the international coordination of the pharmacopoeia in terms of drug regulatory concepts, quality control requirements, application of testing technology, production process control, and product development, as well as taking into account the actual situation of the Chinese pharmaceutical industry. This has positive implications for promoting Chinese pharmaceutical exports overseas." Wang Maochun, vice president of the China Chamber of Commerce for Import and Export of Medicines and Health Products (hereinafter referred to as the "Medical Insurance Chamber of Commerce"), said.

As we all know, with the globalization of economic development, the pharmaceutical industry has formed a global synchronous R & D and registration, large-scale production and large-scale circulation. Therefore, drug standards can not only become a catalyst to promote international economic exchanges, but also become artificial technical barriers to international trade. As the so-called "get the standard to win the world", if China's pharmaceutical industry wants to "go out" and occupy a place in the international market, the standard must go first.

Wang Maochun said that as an observer unit of the 11th Pharmacopoeia Committee, the Medical Insurance Chamber of Commerce has repeatedly assisted in organizing and participating in exchange activities between the National Pharmacopoeia Committee and the World Health Organization, Europe, the United States, Japan and other relevant institutions. While transforming the relevant guiding principles of ICH, the State Pharmacopoeia Commission also discussed some drug standards, sought the "maximum common divisor", accelerated the strategy of "bringing in and going out" of the industry, and helped China's related products go to sea quickly."

Ma Jing also told reporters that the 16 new testing methods in the new pharmacopoeia are not only more scientific and reasonable in reflecting product quality, but also more in line with international standards in methodology. "Taking the revision of the four glass method standards as an example, they are not only standardized according to the pharmacopoeia format, but also refer to ISO international standards and the technical requirements of European and American pharmacopoeia for testing."