CFDA will purchase drug review services from third parties

Source: e-medicine Facebook 2014-05-15 guide reading China's drug review has always been inefficient and understaffed Yin Li, deputy director of CFDA, said that government purchase of services will become an important means to improve the efficiency of drug review This is the first time that the government has explicitly stated that it will "purchase review services from a third party" How does the industry view this initiative? On May 12, Yin Li, deputy director of CFDA, confirmed at the 6th China Annual Meeting of drug information association that: government purchasing services will become an important means to improve the efficiency of drug review Purchase services from a third party, which is a temporary solution to the efficiency of CDE drug review, has been popular in the industry for a long time, and there are many disputes about it This time, through Yin Li's announcement to the outside world, our focus is: what are the services provided by the third party? Does the outsourcing fully consider the prudence of drug review? How to ensure efficiency and fairness at the same time? Yin Li pointed out that foreign pharmaceutical companies and regulatory agencies have been seeking a balance between "scientific truth" and "commercial interests" After several years of efforts, a system has finally been formed, which is based on law, dominated by enterprises, assisted by market incentives and government supervision Under the background of learning from international experience, the newly revised drug registration management method will be more oriented, and the administrative approval matters for CFDA will be further reduced In addition to entrusting some drug registration applications to the Provincial Bureau and gradually realizing the review and approval pattern of classification responsibility and mutual support between the State Administration and the Provincial Bureau, we will also study and improve the new drug review charging policy, and adopt the way of government purchase services to solve the outstanding problem of shortage of drug reviewers Now, for the first time, the government has made it clear that it will "purchase review services from a third party" How does the industry view this initiative? Feng Yi, assistant director of the former drug review center and senior consultant of Barrington & coventon law firm, said: in the United States, FDA adopts the way of "enterprise declaration, if there is no doubt within a certain period of time, it will be deemed as default" for the approval of new drug registration application The premise of this is that foreign countries have made detailed access regulations on ethics, PI capability, enterprise behavior norms and other links, and multiple regulations can ensure the effect of implementation after decentralization if they work together Song Ruilin, executive director of the center for pharmaceutical policy research of the Chinese Pharmaceutical Association, said that before choosing a third-party service, the state should first make clear why, then on this basis, make clear how to do it, have standards, and then discuss who will do it Fang Fang believes that whether it is the revision of drug registration management measures or the revision of drug management law, we should first make clear the basic idea of drug supervision: in drug supervision, we should attach importance to evidence and procedures Only when the source of evidence and the process of evaluation and implementation are clear, can enterprises carry out drug declaration according to the determined standards, and thus become the main body responsible for the results Shao Rong, Professor of China Pharmaceutical University, revealed the progress of two think tank teams participating in the revision of the Drug Administration Law: one team revised the terms of clinical research application to "application 90" in the revision of the drug registration administration measures After days, if no reply is received from the drug regulatory department, it will be passed by default Another team will change the registration terms to "a certain time after declaration, if no reply is received, it will be passed by default" According to Shao Rong's judgment, no matter how the final time limit is determined, the mode similar to the US approval is very likely to be implemented in this amendment Since the establishment of the State Food and drug administration, the drug regulatory department has carried out the special rectification of drug safety and the promotion of drug regulatory reform at the same time, and solved the existing problems from two aspects of samples The administrative power boundary between "decentralization" and strengthening supervision is not clear One thing is for sure, Yin Li's official attitude is that in recent years, the main reason for drug quality is not to comply with, not to implement and flexibly implement drug policies That is to say, no matter to whom the power is delegated, the regulation will be increasingly strict