Pharmaceutical industry, a new round of knockout begins!
The first 2016 China pharmaceutical regulatory science conference hosted by China pharmaceutical regulatory Research Association was held in Beijing.At the meeting,cypress blue learned that the preparation of the 2020 edition of Chinese Pharmacopoeia had begun.
According to Zhang Wei,Secretary General of the national pharmacopoeia commission,6400 products are planned to be included in the 2020 edition of the Chinese Pharmacopoeia.Compared with the 5608 varieties included in the 2015 edition,an increase of 800.Focus on increasing the collection of standards for raw materials,traditional Chinese medicine and pharmaceutical accessories.
Among them,220 varieties of traditional Chinese medicine,420 varieties of chemical drugs,30 varieties of biological agents,100 varieties of pharmaceutical excipients and 30 varieties of drug packaging materials are proposed to be added.
The 2020 edition of Pharmacopoeia plans to revise the standards of 1400 varieties,including 500 traditional Chinese medicines,600 chemical drugs,150 biological agents and 150 pharmaceutical excipients.
Shi Zhijiang,a well-known expert in the industry,told cypress blue that each revision of the pharmacopoeia is an improvement of the standard.After raising the standard,enterprises below the standard will be eliminated.It can be said that each revision of the pharmacopoeia is a knockout.For example,in the 2015 edition of the Pharmacopoeia,43 varieties were kicked out compared with the 2010 edition.
The standard of decoction pieces of traditional Chinese medicine will be further improved
On December 1 last year,the 2015 edition of the Pharmacopoeia began to be implemented.As a major feature of the new edition of the Pharmacopoeia,the standard of decoction pieces was greatly improved.
The standard of Chinese herbal medicine prepared pieces has been greatly improved,especially the safety index.The limit standard of sulfur dioxide residue in Chinese herbal medicine and prepared pieces has been increased,and the standards of agricultural residues,heavy metals and Aspergillus flavus have been increased.The effective solution of these indexes depends on the standardization of the whole industrial chain of Chinese herbal medicine,especially the planting and trade of Chinese herbal medicine.Just the setting of this standard has greatly increased the direct call cost of many traditional Chinese medicine enterprises.In the traditional Chinese medicine market,after the improvement of the standard,some pharmaceutical manufacturers told that many pharmaceutical manufacturers have encountered a wave of return.
Relevant people said that the new pharmacopoeia in 2020 will further strengthen the formulation of standards for the safety of traditional Chinese medicine.It is planned to establish the formulation of limit standards for pesticide residues and heavy metals of some varieties on the basis of large-scale investigation of pollutants in traditional Chinese medicine and scientific research and big data with reference to the method of food safety assessment.
This means that the standard of traditional Chinese medicine will be further improved in the future.
A manager of a traditional Chinese medicine enterprise sighed:if traditional Chinese medicine enterprises do not build their own medicine base,it will be impossible.If they produce and purchase medicinal materials according to the current mode and want to be so strict in drug supervision and inspection,especially when the recent warning to pharmaceutical enterprises requires all enterprises to pay attention to pharmaceutical raw materials,it will be too late to plan until the standards are improved in 2020.
Traditional Chinese medicine injection is the focus of attention
The 2020 edition of Pharmacopoeia plans to add 800 varieties,including 220 traditional Chinese medicine.Although the added varieties are less than chemical drugs,considering that the number of varieties of Chinese patent drugs is less than chemical drugs,this growth rate is worthy of attention.For traditional Chinese medicine enterprises,this is also the process of a new round of standard improvement.
In terms of traditional Chinese medicine,safety research is the focus of traditional Chinese medicine.According to the person concerned,the Pharmacopoeia will focus on the establishment of allergy and allergic substance control methods and control limits of traditional Chinese medicine injections.
Recently,the study on the inducement of anaphylactic shock in China released for the first time by Peking Union Medical College Hospital showed that drugs are an important cause of anaphylactic shock in Chinese people,accounting for 7%.In the case of drug sensitization,traditional Chinese medicine injection ranked first,accounting for 37%.Qingkailing injection,Shuanghuanglian injection and Houttuynia injection were the most common;Antibiotics ranked second,accounting for 24%,mainly penicillin;Antipyretic and analgesic drugs ranked third,accounting for 16%.
This actually provides a direction for the safety research of traditional Chinese medicine injections.If the company can take the lead in achieving results in this regard,I believe its research results will be first absorbed by the Pharmacopoeia.
Innovative drugs are supported
In the revision of this Pharmacopoeia,the support for innovative drugs is also one of the important contents.New preparations are included in time to fully reflect the achievements of pharmaceutical innovation.
This is good news for enterprises engaged in pharmaceutical innovation.The state has increased the collection of innovative drugs,which means that you will become the pharmacopoeia standard of this variety.
In terms of chemical drugs,there may be a lot of investment in making innovative drugs.At present,the traditional Chinese medicine law is being revised to produce qualified traditional Chinese medicine compound preparations from ancient classic prescriptions.When applying for drug approval number,only non clinical safety research data can be provided.Although many classic prescriptions already have products,what if there are any?Especially for some ethnic medicine,it should be an opportunity.
How should enterprises adapt to the new pharmacopoeia
What principles should the preparation of the 2020 edition of Pharmacopoeia adhere to and how should enterprises respond to changes in order to better adapt to changes?According to Zhang Wei,the main principles of the 2020 edition of Pharmacopoeia include:
First,we should enhance the quality of drugs and adhere to the scientific,advanced,practical and normative drug standards.
Second,encourage technological innovation and enable more scientific research achievements to be transformed and applied in drug standards.
Third,adhere to the survival of the fittest,increase and decrease the varieties collected,optimize the increment and reduce the stock.
Fourth,improve the standard formation mechanism,highlighting the government led and enterprises as the main body.
Fifth,drug standard formulation and consistency evaluation,case evaluation of traditional Chinese medicine injections,sampling inspection for drug quality evaluation,adverse drug reactions and other interactions.