Study On The Policy Of Generic Drug Consistency Evaluation

For China's pharmaceutical industry,more than 95%of chemical drugs are generic drugs.In recent decades,generic drugs have played an important role in securing basic medical supplies and meeting the accessibility and affordability of the people.However,there are some gaps in the efficacy and safety between some domestically produced generic drugs and brand-name drugs.In 2012,the State Council issued the National Drug Safety Twelfth Five-Year Plan',which clearly stated that the generic drugs approved before the implementation of the Drug Registration Regulation' revised in 2007 need to be evaluated compared to brand-name drugs by stages and by batches.The Central Office of China,the Office of the State Council,and the China Food and Drug Administration have successively issued documents to promote the reform of the generic drug consistency evaluation policy.The paper uses literature research,comparative research,questionnaire survey and other methods to monitor the reform of China's generic drug consistency evaluation policy,and analyzes and discusses the reform background,policy objectives,reform process,and incentives etc.A comparative study on the implementation process and policy effects of the generic drug evaluation policy in the United States,Japan,etc was made.The survey of the support of the stakeholders of the generic drug consistency evaluation policy was taken.The paper discusses the relationship between the generic drug consistency evaluation and the drug standards.Policy recommendations are provided for the reform of the consistency evaluation policy in China.Generic drug consistency evaluation policies and self-examination and verification of clinical trial data opened a good start for generic drug registration and strict quality supervision,but some problems were encountered in the current policy implementation.First of all,as a phased policy,the consistency evaluation policy is mainly driven by the regulatory documents issued by the State Council and the CFDA.It lacks the connection between the upper-level laws,lacks forward-looking and long-term system design,including the generic drug marketing authorization system,and drug post-marketing re-evaluation,and generic drug fraud punishment regulations.Secondly,the reference preparations have low availability or mismatch,and complex,specific generic drugs' approval guidelines need to be further determined.Thirdly,the first batch of 289 varieties with low completion rate,enterprises lacks sufficient motivation for evaluation,etc.Fourth,some national pharmaceutical standards for generic drugs are still insufficient compared with developed countries.The task of reform is heavy and difficult.In the analysis of generic drug consistency evaluation policy in the history of the United States and Japan,it was found that the US DESI evaluation method is based on the three-party evidence of government,enterprises and scientific literature.Japan's drug effectiveness evaluation refers to the US DESI.The evaluation method establishes the scientific literature screening evaluation drugs,the enterprise submits the certification materials,and the Pharmacy Committee deliberation and other methods.The re-evaluation of drug quality in Japan was mainly carried out by in vitro dissolution test,and the dissolution curve of the preparations was compared with brand-name drug's curve in four different dissolution medium.The consistency evaluation of generic drug focused on the generic drug marketing authorization in China,mainly using in vivo bioequivalence.In the comparative study on the drug standards of representative drugs in China,the United States,Japan,the European Union and other countries,it was found that some of the provisions in China's drug standards are not detailed enough and the standards are low,which will have negative impact on the quality of generic drugs.During promoting the generic drug consistency evaluation policy,drug quality standards system should be improved.In the questionnaire survey,respondents believe that there is difference in the safety of generic drugs compared with the brand-name drugs.There is difference of the quality of generic drugs produced by different manufacturers.Some antibiotics and cardiovascular generic drugs are complained during clinical use.Pharmacists have low trust in China's current generic drugs,and have high support for generic drugs' quality and efficacy consistency evaluation policy.In the policy of generic drug consistency evaluation,the information transparency is high,the communication channels are diverse,the database of approved generic drugs has been established.But,the passing rate of 289 drugs in the list of essential drugs is low.It is recommended to consider the pharmaceutical industry conditions and patients' need,and there is a certain buffer period in time.Continue to increase the incentives for the 289 varieties to pass the generic drug consistency evaluation,including the improvement of financial incentives,procurement,medical insurance payment policies etc.We should perfect laws and regulations such as the Drug Administration Law and Drug Registration Regulations as soon as possible.The reference listed drugs should be as clear as possible,and the exempted varieties based on the BCS classification should be announced timely,and the guidelines for the approval of specific product generics,and complex generic drugs should be improved.For the drugs that passed the consistency evaluation,policies such as procurement,use,and medical insurance payment policies should be refined to form a strong incentive system.To avoid generic drug consistency evaluation becomes'one-time evaluation',it is necessary to establish a total life cycle supervision system.Improving the trust of generic drugs,and giving full play to the pharmacist's main responsibility,gradually implementing the generic drug substitution policy,and constantly improving the generic drug policy.The main innovations of the paper are:(1)systematically summarize and conclude the elements of the denefinations of the generic drugs and reference list drug.(2)Monitoring,analysis and evaluation of the background,process,obstacles,stakeholders,and the transparency of the reform.(3)Dialectical thinking on the relationship between consistency evaluation and drug standards.(4)This study conducted a detailed survey of domestic pharmacists' views on generic drug knowledge,opinions,and consistency evaluation policy.The design of open question provides a reference for future evidence-based pharmaceutical research and real-world evidence research.