Improving Drug Standards to Ensure Drug Quality


Release time:

2017-12-15

In recent years, the upstream and downstream enterprises of pharmaceutical production have deeply felt that the revision and promotion of drug standards have become the new normal. After exploration and practice, the State Administration has formed a set of scientific, fair and transparent drug standard improvement selection and evaluation system, and the enthusiasm of enterprises to participate in the standard improvement is increasing.
 
Core Tips
 
In recent years, the State Food and Drug Administration has made great efforts to improve China's drug standards and gradually improve the standard system. At present, 3050 national drug standards and 500 medical device standards have been revised and completed, and a qualified answer sheet has been handed over to the people for drug safety.
 
●At present, my country has nearly 20,000 national drug standards, of which 5608 have been included in the 2015 edition of the "Chinese Pharmacopoeia", and the drug standard level has reached or approached the world-class level.
 
● At present, China has made great progress in improving the standards of pharmaceutical excipients, and has completed the drafting and approval of nearly 200 standards of pharmaceutical excipients. The total number of varieties of pharmaceutical excipients included in the pharmacopoeia reached 270, with an increase of 105, accounting for nearly 50% of the varieties of commonly used pharmaceutical excipients, alleviating the problem of less standards for pharmaceutical excipients in China.
 
 
In April this year, the 2015 English version of the Chinese Pharmacopoeia was published, causing a huge sensation in the European and American pharmaceutical industries. Professor Luo Guoan of Tsinghua University, chairman of the physical and Chemical Professional Committee of the State Pharmacopoeia Commission, editor-in-chief of the four English editions of the 2015 edition of the Chinese Pharmacopoeia, said excitedly, "the drug standards currently implemented in China have reached the world-class level, which is comparable to the drug standards of Europe, America and Japan."
 
Drug standards are an important basis for drug safety supervision. General Secretary Xi Jinping pointed out during the 23rd collective study of the Political Bureau of the Central Committee that it is necessary to effectively strengthen food and drug safety supervision, and use the most rigorous standards, the most stringent supervision, the most severe punishment, and the most serious accountability to accelerate the establishment of science. Perfect food and drug safety governance system. In recent years, the State Food and Drug Administration has vigorously improved my country's drug standards and gradually improved the standard system. At present, 3050 national drug standards and 500 medical device standards have been revised and completed, and a qualified answer sheet has been handed over to the people for drug safety.
 
Three types of standard weave density quality safety net
 
Drug standards are the technical regulations made by the state on drug quality indicators, inspection methods and production processes in order to ensure the quality of drugs; they are mandatory technical guidelines and laws that must be observed in all aspects of drug production, operation, use, supervision and management. basis. The level of drug standards reflects the level of development of a country's pharmaceutical industry. The improvement of drug standards plays a very important role in improving drug quality, improving drug supervision level and ensuring people's drug safety.
 
"Drug standards are the basic technical requirements for a target compound or prescription process, and are one of the important bases for daily inspection or evaluation of drug quality compliance. The perfection of drug standards is the ultimate manifestation of comprehensive strength such as process level, analytical technology and personnel quality." Said Tu Jiusheng, professor of pharmacy, doctoral supervisor, member of the National Pharmacopoeia Committee, and deputy director of the Pharmaceutical Excipients and Package Materials Committee of China Pharmaceutical University.
 
At present, there are nearly 20,000 national drug standards in my country, of which 5608 have been included in the 2015 edition of the "Chinese Pharmacopoeia", and the level of drug standards has reached or approached the world-class level.
 
It is understood that China's three types of drug standards play different roles in quality control.
 
The "Chinese Pharmacopoeia" is the core of the national drug standard system. It is formulated and revised by the National Pharmacopoeia Committee organized by the National Drug Administration. It is a code with national legal effect that records drug standards and specifications.
 
As the basis of the national drug standard system, the drug registration standard is the quality standard for the products approved by the drug evaluation center and technical experts organized by the national drug supervision and administration department to review the safety, effectiveness and quality controllability of the drug research data declared by the applicant. It is the specific drug standard approved to the applicant, The manufacturer of the drug must implement the registration standard. The provisions of the drug registration standards shall not be lower than the provisions of the Chinese Pharmacopoeia.
 
As the extension of the national drug standard system, the bureau/ministry standard is the drug standard after the national drug supervision and administration department organizes the National Pharmacopoeia Committee to unify and standardize the drug registration standards of different enterprises. In general, pharmacopoeia and bureau/ministerial standards are the most basic quality requirements for drugs. For production enterprises, their factory internal control standards or registration standards must be higher than the unified standards set by the state.
 
"At present, the channels between the three types of drug standards in China have been opened up, they promote each other and improve each other, and the reform of drug standards has entered the 'new normal '." Zhang Wei, secretary-general of the State Pharmacopoeia Committee, said that taking the standard of pharmaceutical packaging materials with relatively weak standards as an example, in the past five years, the Pharmacopoeia has taken it as the focus of standard promotion, increased the collection and promotion efforts, and focused on the role of industry organizations. Registered standards and industry standards are important sources of pharmacopoeia standards, and focus on the establishment of verification and quality methods. Judging from the revision of the pharmacopoeia, the funding for scientific research projects in the 2010 edition of the pharmacopoeia standard for pharmaceutical packaging materials was 4 million yuan, and the 2015 edition of the pharmacopoeia increased to 10.82 million yuan.
 
When talking about the changes in the standards of pharmaceutical excipients, Tu Jiasheng said that great progress has been made in the improvement of the standards of pharmaceutical excipients in China, and nearly 200 standards for pharmaceutical excipients have been drafted and approved. The total number of varieties of pharmaceutical excipients included in the pharmacopoeia reached 270, with an increase of 105, accounting for nearly 50% of the varieties of commonly used pharmaceutical excipients, alleviating the problem of less standards for pharmaceutical excipients in China; the 2015 edition of Pharmacopoeia comprehensively revised the general rules of pharmaceutical excipients, strengthened the production, use, quality control and applicability research of excipients, and improved the quality and safety of pharmaceutical excipients as a whole. Pay attention to the research on the standard system of pharmaceutical excipients and drug packaging materials and the formulation of technical requirements related to drugs, and provide technical guarantee for enterprises to implement the review and approval system of drug packaging materials, pharmaceutical excipients and drugs. At present, China's drug standards have basically completed the work of local drug standards to rise national drug standards.
 
China's drug standards are valued by the world
 
"The standard level of China's chemical and biological drugs has basically been in line with international standards, and Chinese medicine standards are in a leading position in the global botanical drug standards. This reminds enterprises that in the future, China's drug standards will closely follow the world's high-end market, and the standards will be higher and higher, showing the quality style of a major pharmaceutical country." Said Wang Youchun, deputy chairman of the Virus and Vaccine Professional Committee of the National Pharmacopoeia Commission and editor-in-chief of the three English versions of the Pharmacopoeia.
 
It is reported that my country has been pushing the "Action Plan for Improving National Drug Standards" since 2008. The achievements in the past five years are obvious to all. my country's drug standards have attracted more and more attention from the world, reflecting the international recognition of "Chinese medicine" in terms of safety and effectiveness. China and the United States signed a memorandum of understanding on pharmacopoeia cooperation in 2008. Starting from the 2010 edition, the translation rights of the Chinese version of the United States Pharmacopoeia were granted to China. At the same time, the English version of the Chinese Pharmacopoeia is sold overseas. In May 2016, the National Pharmacopoeia Commission and the British National Pharmacopoeia Commission formally signed a memorandum of understanding on cooperation. In October, the National Pharmacopoeia Commission and the European Pharmacopoeia Commission agreed to sign a memorandum of understanding on pharmacopoeia cooperation as soon as possible. In 2016, the National Pharmacopoeia Commission conducted the English version of the "Chinese Pharmacopoeia" publicity activities in Europe and the United States, and held a drug standard development forum in conjunction with the American Chinese Medicine Association, which was the first comprehensive and systematic promotion of Chinese drug standards overseas. At present, the Chinese Pharmacopoeia, together with the United States Pharmacopoeia, the British Pharmacopoeia and the European Pharmacopoeia, are listed as one of the main references for the World Health Organization to formulate the International Pharmacopoeia ...... "The National Pharmacopoeia Commission has established close cooperative relations with the drug standards bodies of more than a dozen countries and regions, including the World Health Organization, the European Union, the United States, the United Kingdom, France and Japan." National Pharmacopoeia Commission General Division Deputy Director Hong Xiaoxu said.
 
With the development of a series of bilateral and multilateral international cooperation activities, China's drug standards are gradually being familiar with and recognized by the international community, and their influence in the world is increasing. More and more multinational pharmaceutical companies begin to attach importance to China's drug standards.
 
In 2011, China launched the first overseas inspection of imported drugs, and the first batch of inspectors went abroad for inspection. In the inspection, China's drug standards exert great power to minimize the insecurity of imported drugs. Zhang Hua, a national drug inspector of the Shanghai Institute for Drug Control and the first batch of overseas production site inspectors recognized by WHO, said that in the past, because foreign companies had higher R & D and quality standards than domestic ones, individual foreign companies did not pay enough attention to my country's drug standards, and their production had quality. Safety risks. With the improvement of my country's drug standards, we dare to carry out overseas inspections to make foreign companies deeply aware of the strictness of China's drug standards. As a result, some multinational pharmaceutical companies have upgraded and rectified their standards.
 
Open up the road to improve drug standards in China
 
In May this year, a warm atmosphere of "pharmaceutical excipients standard enterprise symposium" was held in Anhui. The State Pharmacopoeia Commission, domestic drug inspection institutions, scientific research institutes and foreign senior experts had close exchanges with representatives of enterprises such as Anhui Shanhe, Liaoning Aoke and Huzhou Prospect, and listened to the opinions and suggestions of enterprises on the standard of auxiliary materials. After the meeting, Yin Zhenglong, chairman of Anhui Shanhe Pharmaceutical Accessories Co., Ltd., said that this meeting is just a glimpse of the standard revision and improvement. In recent years, the upstream and downstream enterprises of pharmaceutical production have deeply felt that the revision and promotion of drug standards have become the new normal.
 
At present, after exploration and practice, the State Administration has formed a set of scientific, fair and transparent drug standard improvement selection and evaluation system, and the enthusiasm of enterprises to participate in the standard improvement is increasing. Many enterprises hope to actively transform enterprise standards into national standards and pursue high standards of drug production and quality, so as to form core competitiveness and achieve sustainable development.
 
"Now our customer list is more and more domestic pharmaceutical companies. In the past, domestic enterprises on the quality of raw materials is not high, the purchase price is more sensitive, but with the continuous improvement of drug standards, gradually with international standards, domestic enterprises are experiencing pain in drug quality and safety, many enterprises began to pay attention to the quality of the whole life cycle of drugs, the implementation of fine production, high-quality raw materials by the chase bar." Chen Wenyan, head of the public affairs department of Calekang (China), the world's leading pharmaceutical excipients company, said.
 
"Drug standards play a dual role in production. On the one hand, it puts forward higher requirements for backward enterprises, and on the other hand, it provides technical protection for advanced enterprises. The competition of enterprises in the future is the competition of the scientific and technological connotation of products and the advanced nature of quality standards, and backward enterprises will be gradually eliminated." Luo Guoan said.
 
 

Yan Hui, senior director of RDPAC, said that in recent years, the national drug regulatory authorities have made unremitting efforts to improve drug standards, constantly absorb international experience, and found a development path suitable for China in the revision and compilation of drug standards.
 
Zhang Wei pointed out that the future drug standard improvement reform will be guided by the five development concepts of "innovation, coordination, green, openness, and sharing", adhere to the principles of "scientific, advanced, practical, and standardized", and adopt a'high, high, medium, and low. 'The strategy of classification treatment. "The value of pharmacopoeia standards is to improve the health of the people by establishing and implementing world-class standards to provide drugs of consistent quality, safety and effectiveness. Continuously improving drug standards and ensuring drug quality is a hard commitment made by drug regulators to the people."