我国仿制药一致性评价:机遇、挑战及对策

Evaluation of the Consistency of Generic Drugs in China:Opportunities,Challenges and Countermeasures

通过了解我国仿制药一致性评价的概况,展望我国一致性评价阶段医药行业发展趋势。梳理仿制药一致性评价的发展现状和存在问题,针对现有问题并结合国家监管部门相继出台的一系列政策,从产业发展角度进行了分析。通过分析该文认为仿制药的一致性评价工作对中国医药行业的发展具有深远的影响,通过一致性评价的产品必将在未来医药市场竞争中发挥积极作用。目前,仿制药的一致性评价工作已进入攻坚阶段,这也体现了我国政府对医药行业改革的态度和决心,同时仿制药一致性评价的工作也会大力促进中国的仿制药走向国际市场。面对挑战尤其要做符合以下特点的仿制药:患者刚性需求;无需医保支付;非医院渠道销售为主。当然,随着注射剂一致性评价工作的逐步启动,还有一类仿制药非常值得关注,那就是可注射特殊制剂的仿制药。通过一致性评价的有效实施,在满足公众基本医疗保障的同时,我国将会从制药大国逐步转变为制药强国。

By understanding the overview of the consistency evaluation of generic drugs in China,we look forward to the development trend of the pharmaceutical industry in the post-consistency evaluation stage of China.The development status and existing problems of the consistency evaluation of generic drugs are sorted out,and the existing problems are combined with a series of policies issued successively by the national regulatory authorities to analyze from the perspective of industrial development.Through analysis,we believe that the consistency evaluation of generic drugs has a profound impact on the development of China's pharmaceutical industry,and products that have passed the consistency evaluation will definitely play an active role in future competition in the pharmaceutical market.At present,the consistency evaluation of generic drugs has entered a tough stage,which also reflects the Chinese government's attitude and determination to the reform of the pharmaceutical industry.At the same time,the consistency evaluation of generic drugs will also vigorously promote China's generic drugs to the international market.In the face of challenges,in particular,generic drugs that meet the following characteristics:patients'rigid needs;no medical insurance payment;and non-hospital channel sales.Of course,with the gradual start of the evaluation of the consistency of injections,there is also a class of generic drugs that are very worthy of attention,that is,generic drugs that can be injected with special formulations.Through the effective implementation of consistency assessment,while meeting the basic medical security of the public,China will gradually transform from a big pharmaceutical country to a strong pharmaceutical country.