Promote consistency assessment
Minenet data shows that the consumption scale of chemical injections in the domestic market (public medical institutions terminal+urban retail pharmacy terminal) reached 626.404 billion yuan in 2065438+2008. From the annual growth rate, the growth rate of chemical injections in public medical institutions has slowed down year by year, and the volume of chemical injections in urban retail pharmacies has accelerated year by year.
Injection is regarded as one of the high-risk varieties by drug supervision departments all over the world because of its drug administration characteristics. Since the launch of 20 15, the related policy support and enterprise implementation have been steadily promoted. However, in the field of chemical injections, since 20 17, the Drug Evaluation Center ("CDE") of the State Administration of Pharmaceutical Products issued the Notice for Soliciting Opinions on Technical Requirements for Conformity Evaluation of Listed Chemical Generic Drugs (injections), there has been no specific guiding document for conformity evaluation of injections due to various factors. The release of the two drafts for comments indicates that the follow-up injection consistency evaluation is expected to speed up.
Generic drugs refer to raw materials and their preparations with the same active ingredients, dosage forms, specifications, indications, routes of administration, usage and dosage as the original drugs. Generic drugs should be consistent with the quality and efficacy of the original drug, and can replace the original drug to play the same clinical efficacy. Generic drugs play a leading role in clinical drug use in China.
Injection refers to a sterile preparation made of drugs and suitable excipients for injection into the body, which mainly includes injection, sterile powder for injection and concentrated solution for injection. Because it is directly injected into blood vessels, tissues or organs, it is fast in absorption and quick in action. Especially intravenous injection, the drug directly enters the blood circulation to exert its efficacy, which is a high-risk dosage form for clinical use, and the technical requirements for its research and development and production are correspondingly stricter. The consistency evaluation of chemical generic injections is not limited to the first batch of 289 varieties like the previous oral solid preparations, but sodium chloride injection, glucose injection, glucose sodium chloride injection and water for injection are not included in the consistency evaluation in principle, which means that almost all chemical generic injections should be evaluated for consistency.
Improving the quality of generic drugs for injection
The Technical Requirements for Conformity Evaluation (Draft for Comment) issued this time requires enterprises to fully understand the domestic and international marketing background, safety and effectiveness data, post-marketing adverse reaction monitoring, evaluate and confirm its clinical value, and put forward specific requirements for reference preparations, prescription technology, raw and auxiliary packages, quality research and control, stability and special injections/injections with modified specifications, and clarify the varieties that can be exempted.
Generally speaking, this document puts forward higher requirements for domestic enterprises on raw materials, auxiliary materials, packaging materials, filling and other technologies of injections, as well as changing specifications and groups. Promote the upgrading of domestic chemical generic drugs from "imitation standard" to "imitation quality", establish and improve the risk quality control system of injection generic drugs, and comprehensively improve the quality level of injection generic drugs in China.
2065438+May 2008, azithromycin for injection of Puli Pharmaceutical became the first injection that passed the consistency evaluation of supplementary application.
According to the statistics of drug situation, by the end of September, the number of applications for injection conformity evaluation accepted by the State Administration of Pharmaceutical Products was 434, involving 120 varieties. In terms of the number of enterprise declarations, the leading enterprises in the industries such as Kelun Pharmaceutical, Qilu Pharmaceutical, China Biopharmaceutical, Changjiang Co., Haosen Pharmaceutical and Hengrui Pharma have the highest number of declarations. At present, only azithromycin for injection has passed the consistency evaluation according to the supplementary application, and the other nine varieties for injection that have passed the evaluation are approved for production according to the new registration classification of chemicals (deemed to have passed the consistency evaluation).
Three major trends in the industry
Chen Yongfa, a professor at the School of International Medicine and Business of China Pharmaceutical University, said that after the consistency evaluation of injections, the industry will show three major development trends.
First of all, the market of each injection variety will be divided by a few enterprises, and the industry concentration will be greatly improved.
The Technical Requirements for Consistency Evaluation of Quality and Efficacy of Chemical Injection Generic Drugs (Draft for Comment) only excludes a few varieties such as sodium chloride injection and glucose injection from the scope of consistency evaluation. This means that almost all injection varieties must be evaluated for consistency. The state stipulates that "there are more than three enterprises that have passed the consistency evaluation of the same variety of drugs, and the varieties that have not passed the consistency evaluation will no longer be selected for centralized procurement". At present, 32 provinces (cities, districts) have implemented this policy. It can be predicted that with the development of large-scale consistency evaluation of injection varieties, the top three enterprises that have passed the re-evaluation will carve up an injection market, and the remaining enterprises with this variety may face elimination.
Secondly, ensure the quality and efficacy of domestic injections and gradually replace the original drugs. The national technical requirements for consistency evaluation of injections strictly refer to European and American drug regulatory laws to ensure that the quality and efficacy of injections that pass the consistency evaluation are equivalent to those of the original drugs. On this basis, the policies of "giving the products that have passed the consistency evaluation the same treatment as the original drug in terms of bidding, procurement and medical insurance payment" and "drug patent link and test data protection" have created a good external environment for generic drugs to replace the original drug. Under many favorable conditions, domestic injections will gradually replace the original research drugs, which is expected to break the monopoly of the original research products.
Third, influenced by policy-driven or product quality improvement, more local enterprises will enter overseas markets. Influenced by the policy of "supporting domestic enterprises to list drugs approved by the European Union, the United States or Japan in China", some enterprises with certain R&D capabilities will use this policy to obtain certification and approval abroad, and then declare conformity evaluation to the State Administration of Medical Supplies to speed up the approval process. In addition, the domestic injection that has passed the consistency evaluation is expected to replace the original product in clinical treatment. This will greatly improve the international competitiveness of generic drugs in China. It is expected that more local enterprises will try to explore overseas markets to increase product sales.
Source: china securities journal.