Medical net September 11, September 5, "the 2020 edition of China pharmacopoeia" the preparation of a small press conference in Beijing. According to the press conference, based on the overall situation of the national drug standards, the estimated number of available varieties is estimated to be about 6,400 by 2020. Increase about 220 varieties including: traditional Chinese medicine, chemical medicine increase about 420 varieties and varieties of biological products increase contains 30, increase varieties of around 100 pharmaceutical excipients, varieties of medicine packaging material contains 30, a total of about 800.
The reporter understands in the meeting, our country has been smoothly through the special period of underserved, pharmacopoeia fix for work by notice contains quantity of the drug, to pay attention to drug internal quality improvement. Zhang wei, secretary general of the national pharmacopoeia commission, explained that the variety of pharmacopoeia is based on the principle of optimizing incremental and reducing stocks. Aim for international standards, aim for advanced, seek gaps, and catch up. In addition, the national drug standard elimination mechanism should be established, the standard should be "in and out", and increase the standard of elimination.
For problems to be eliminated varieties, zhang wei said that for an approval number has been cancelled, long-term don't production, quality control, dosage form is not reasonable, the stability is not high pharmaceutical standards of "subtraction", or terminate the validity of the standard, so as to realize standard. Eliminate pharmacopoeia standard means that the species is not in conformity with the pharmacopoeia standard contains principles, standards continue to be valid but should improve and perfect, such as standard problems involving safety uncontrolled standards, should be immediately put an end to increase after the implementation of the new standard.
In addition, there are some pharmacopoeia that are excluded from international recognition or national discourses, and may be phased out in the future.
Drug standard "short board"
It is understood that from 1953 the first edition of "Chinese pharmacopoeia", our country has issued and implemented the ten version pharmacopoeia, from scratch, contains standardized medicines from less to more, standard level from low to high, to improve the level of drug quality in our country, promote the transformation and upgrading of the pharmaceutical industry has played an important role. However, the current "short board" of drug standards is more obvious, mainly reflected in the lack of standards, standards, standards and standards, etc.
"These problems are not present in the drug standards as a whole, but in different degrees in specific varieties or breeds," zhang said. The reason is largely due to the low standard of drug listing in China, and the lack of the original research products as reference preparation. First, there is a lack of standards. On safety control of Chinese herbal medicine and yinpian, and pesticide residues, heavy metals and harmful elements despite the detection method, but the specific varieties of detection limit because of a lack of big data accumulation and analysis, so it can't be set of science. Second, standards lag behind. It is mainly some old varieties that have been approved by the local government in the early years and then rise to the national standard. The standard is not perfect and the quality control is not high. Third, standards don't work. Although impurity inspection methods have been established in some chemical standards, the detection limit has been set up, but no control has been made on toxic impurities. Fourth, the standard implementation is not in place. Enterprises can not accurately understand and master standard, resulting in the failure of standard execution of standards, and the lack of strict prescription process execution and even standard loophole.
The reporter understands, in the future to strengthen and improve the pharmaceutical standards is found that the main task of the risk, control risk, meet the needs of the supervision for the purpose, adhere to the problem oriented, swallow the short board, focus on the safety control, the control effectiveness. Continuous improvement of standards and continuous improvement of quality are always on the road.
"The drug standards are mainly aimed at legal enterprises and their products," said zhang wei. The standard is to share and interact with various drug regulatory activities in the process of revision, and actively discover the "latent rules" signal. On the one hand, we should make full use of the advanced analytical techniques and methods to solve the problems in the inspection, and provide effective means for improving the quality and safety of control. On the other hand, we should cooperate with the supplementary inspection method to improve the target of inspection. According to the requirements of supervision, the test methods of high specificity, good taste and high maturity will be included in the standard.
The pharmacopoeia went hand in hand
In fact, different countries have different requirements for drug standards at certain times. At present, American pharmacopoeia, European pharmacopoeia, Japanese pharmacopoeia, and the international pharmacopoeia established by WHO have high authority. Reporter also learned that some multinational drug companies with higher standards for self requirement, although the drug in some developing countries registered declaration, but they also can choose American or European standards. So, how should pharmaceutical companies balance these pharmacopoeia with registration in China?
"When the drug is registered, the review body will ask for a reference list of medicines, so the choice of the standard is still in the hands of the enterprise," zhang said.
He said the Chinese pharmacopoeia is gradually narrowing the gap with developed country pharmacopoeia in terms of chemical, biological and medicinal materials. Now the Chinese pharmacopoeia, like the American pharmacopoeia, British pharmacopoeia and European pharmacopoeia, is listed as one of the main references for international pharmacopoeia. Standard is drug import and export trade of the world's first "ticket" and "aura", especially after the CFDA formally becomes a member of, for example, Chinese standard gradually in line with international standards has become the inevitable trend.
In the interview, the reporter also learned that the total number of members of the current pharmacopoeia committee was 405. The biggest bright spot in the organization was the establishment of observer seats and the participation of 12 community representatives. Of these, 146 were from the pharmaceutical industry, accounting for 42%; 117 from the research institute, accounting for 33%; Forty were from medical institutions, accounting for 11%; 31 from production enterprises, accounting for 9%; Twelve came from the management department, accounting for 3%.
Look from the pharmacopoeia committee of personnel structure, zhang wei said: "in the European and American pharmacopoeia committee structure, enterprise personnel proportion will be larger, but the pharmacopoeia committee of enterprises accounted for only 9%, this shows that our country enterprise's participation is not enough." In addition, improve the ability of drug standards of Chinese pharmaceutical enterprises and intrinsic motivation, also should pass to speed up the process of the national drug standard formation mechanism reform, namely, to establish "the government guidance, enterprise main body, market orientation, expert guidance, social participation, international coordination" drug standards work mechanism to guide and stimulate enterprises to improve the initiative and self-consciousness of drug standards.
Zhang wei thinks, the enterprise main body role play is mainly manifested in four aspects: one is according to their own positioning, actively carry out the enterprise standard system revision work, and to adopt and absorb the international pharmaceutical standards, on the basis of the national drug standard, form both their technical features and competitive pharmaceutical standards; Second, actively engaged in the industry's drug standard system revision work, strive to become the leader; Third, to participate in the revision of national drug standards on behalf of enterprises or industries and become the main force and contributor; Four is actively participating in international pharmaceutical standards, and revising its own technical ability and familiar with and understanding of international standardization work, affecting international standards, make its content to the direction of more fair.
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