Research On The Drug Review System In The USA

The reform of drug review system is a hot issue at present,and its core is to solve the problem of low delay and low efficiency.The research on the reform of drug review system involves many fields,such as the concept of review,the review system,the review mechanism,the optimization and perfection of the review process.This study uses literature research,comparative research and statistical research methods.From perspectives of organizational structure of review centers,financial resources and expenses,new drug review process,expedited programs for new drug review,useful mechanisms applied in drug review,and policies as the basis of drug review,it describes drug review systems and mechanisms in U.S.A.as a panoramic picture to provide experience for drug review reform in China.There is a big difference between the two countries in setting review centers,set up centralized drug review agencies in the United States FDA.Review agencies and inspection agencies and the advisory committees have good coordination responsibilities,division of labor.The main agencies involved in drug review are Center of Drug Evaluation and Research(CDER),Center of Biologic Evaluation and Research(CBER),Office of Regulatory Affairs(ORA),and advisory committees.In Food and Drug Administration,Center of Drug Evaluation and Research(CDER),Center of Biologic Evaluation and Research(CBER),Office of Regulatory Affairs(ORA),and advisory committees serve main functions in drug review.CDER and CBER review drugs and biologics,ORA conduct inspection relevant to drug review,and advisory committees provide advises and opinions.Pursuant to PDUFA,FDA collects user fees from firms who apply for market approvals for drugs and biologics.User fees have been to main resource for drug review.PDUFA has achieved its goals of decreasing drug review phase and expediting drug research and development.The drug review process design in China and the United States is also different,the submission of activities,filing review,review decisions,review time and other aspects are different from the United States.CDER's NDA/BLA review process involves a total of six major steps,including pre-submitting activities,submission,planning for review of the application,conducting review,taking official action,and post-action meetings.Applicants are encouraged to request a meeting with review division prior to the submission of an NDA/BLA,the regulatory project manager checks the submission to ensure it conformance to regulatory requirements,and discipline team leaders establish review team.If an applicationis fileable,a planning meeting is held to determine schedule for review.Review divisions perform regulatory and scientific reviews,wrap up all review outcomes and plans to address any issues.The signatory authority decides to approve or not approve the application,provides post-decision feedback to review team,and obtains feedback from applicants.Expedited programs in drug review in China and the United States is also different.Expedited programs of FDA including fast track designation,breakthrough therapy designation,accelerated approval and priority review,represent efforts to address an unmet medical need in the treatment of a serious or life-threatening condition.In the phase of IND application,fast track designation applies to the drug which need demonstrating the potential to address unmet medical need,and breakthrough therapy designation applies to the drug if preliminary clinical evidence indicates that he drug may demonstrate substantial improvement over existing therapy on 1 or more clinically significant endpoints.In the phase of NDA application,an application will be granted accelerated approval upon a determination that the product has an effect on a surrogate endpoint or an intermediate clinical endpoint,that is reasonably likely to predict clinical benefit,and an application will receive priority review if it is for a drug that would provide a significant improvement in safety and effectiveness.The review mechanism design of China and the United States is also different,China's advisory committees,communication and dispute resolution mechanism slightly inadequate.Useful mechanisms are designed in drug review including advisory committees,communication,dispute resolution within FDA and formal dispute resolution appeals.Experts provide independent scientific opinions through advisory committee meetings,which enhance openness and transparency in drug review.Communication increases efficiency of review and acceptability of official actions in forms of information requests,letters,formal meetings,and review status updating.Dispute resolution systems within FDA,such as equal voice,scientific/regulatory dispute resolution in management chain,differing professional opinion,and agency scientific dispute resolution,are intended to provide chances for initiators to express their different opinions,and to conduct adequate and open reviews for all scientific disputes.In formal dispute resolution appeals,appeals can be gradually submitted to next management official in the management chain,and then disputes between sponsors and FDA can be addressed quickly.The drug review system regulations and documents in China and the United States is also different.An important policy is applied in drug review in the form of a regulation,a guidance documents,a manual of policies and procedures,or a standard operating procedure.Regulations specify specific matters of some legal mechanism.Manuals of policies and procedures provide direction to reviewers or other staff within the Center on how they are to do their work.Standard operating procedures are specific to the internal functioning of a single office in detail.Those policies ensure drug review integrity,predictability and transparency.Based on these studies,this study suggests that organizational structures of review agencies should be adjusted,responsibilities of review divisions should be perfected,and assistant divisions in the drug review center should be strengthened in China drug review reform.By changing principals of drug review,increasing resources allocation for drug review,observing timeline requirements for review,review performance should be improved.Management practices and technical guidance documents for expedited programs should be specified,expedited programs should be applied in more drugs,and direction from review divisions should be strengthened to those research and development projects applied expedited programs.Review mechanisms should be perfected,such as advisory committees,communication,internal disputes resolution,and disputes resolution between review divisions and sponsor.Review policy systems should be completed and be observed and performed effectively.