Don't be a spectator of reform! Behind the nine "disapproval"

Source: on August 3, 2015, after the State Council required CFDA to "submit the rectification plan for drug review and approval before August 15", CFDA issued a notice on "seeking some policy opinions on accelerating the solution of drug registration application backlog" on the evening of July 31 The announcement elaborated the generic drug evaluation standard and the procedure of "record system evaluation" of "consistent treatment and efficacy", established three thresholds for the newly reported projects: real, complete and valuable, proposed the "centralized evaluation" and "priority evaluation" methods to solve the current problems, and also explained the historical problems and future registration guidance It is worth mentioning that CFDA has included "standardized drug registration review" into the scope of consultation For such a draft of "nine disapprovals", it is an operable measure to straighten out the path of "short hand over" with enterprises As soon as the document was released, it caused extensive discussion in the industry Many in the industry lamented the strength and efficiency of CFDA in promoting the solution to the backlog of drug registration applications, saying that the above-mentioned practices "pricked the pain point"; however, some in the industry said that as a "watershed" in the history of China's drug development and review, the implementation of the above opinions still faced many challenges: first, the operability of policy recommendations Taking "generic drug consistency evaluation" as an example, the progress of national generic drug consistency evaluation in 2012 has been slow so far, which is mainly due to the lack of consensus on the standards of consistency in the industry Although CFDA clearly pointed out that "quality and efficacy" should be examined, it did not decompose the evaluation criteria of quality and efficacy Has CFDA determined the evaluation index, and does the scope of this consultation include specific evaluation criteria? This is not the case Second, how to ensure the sustainability of policy recommendations Among the priority approval proposals, children's drugs, "clinical urgently needed drugs in short supply" and original research drugs whose patents are about to expire are the three types of products proposed to be granted the approval privilege The emphasis on paediatric drugs stems from the fact that such drugs are limited at present; however, with the encouragement of policies, the number of corresponding applications will grow rapidly, and one day CFDA will face the choice: "is it a priority to approve a child cold drug or a rare disease drug?" Third, how to deal with the contradictions between documents At present, the drug administration law and the measures for the administration of drug registration are still in the state of revision Once the draft for comments is officially implemented, CFDA may face doubts due to the contradictions between the documents Take the data retention period of clinical trials as an example: in the 2003 version of the quality management standard for clinical trials of drugs, researchers should keep the data of clinical trials for five years after the termination of clinical trials If the missing clinical trial data is the only and important data to prove the safety and effectiveness of drugs, then enterprises may feel "innocent" when implementing the measure of "clearing away the historical problems" Every major reform will face various voices For those enterprises that want to win reputation and profits through good medicine, if these "care for patients, respect for rules" practices are not written into the law, the possibility of overturning the repeated or similar problems will always exist.