After clinical self examination, what should enterprises do?

Source: sabilan / Zhao Dong, August 28, 2015, CFDA issued the notice of the State Food and Drug Administration on the self inspection of drug clinical trial data (No 169, 2015) No ", which marks the end of the hot clinical self-examination I believe that many enterprises involved are relieved The first one is over, but I think the second one is Phoenix Nirvana How? Let's look for some experience from history First of all, the original text of Announcement No 169 is quoted as follows: "IV The State Food and drug administration shall check the clinical trial data one by one for the drug registration application completed with self-examination data If fraud is found in the verification, the case shall be filed for investigation in time The registration application shall not be approved, and the investigation results shall be made public to the public " "5 The applicant may still voluntarily apply for withdrawal before the verification by the State Food and drug administration The State Food and drug administration shall publish the list of applicants and varieties, and shall not hold them accountable." Generally speaking, we need to check one by one Before we find out, the enterprise can withdraw In fact, one of the interesting things is that there is a slight conflict between the withdrawal time and the previous announcement The author believes that the change of mentality should be understood as follows: the reason why more than 1000 varieties need to be self checked is that the General Administration definitely believes that there are certain problems, only 20% The withdrawal rate of is obviously not up to the psychological expectation of the general administration Well, there must be enterprises with fluke mentality among them According to the announcement of the General Administration, we need to check one by one and leave a gap If you don't think it's safe, it's too late to continue withdrawing How to check in the short term: First, let's try to analyze the centralized rectification of this matter, and carry out the centralized rectification of a certain matter, so as to achieve a significant effect In fact, it is not only a national, but also a personal action preference I believe that everyone has faced a house that hasn't been cleaned for a long time, and then impulsively cleaned it up Then, there is no such thing, and it won't be cleaned up for a long time, so we wait for the next one I can't bear it The same is true for the country Although the four legal crackdowns in the history of new China have different historical backgrounds, they all have the same mentality But the law, drug safety is much more complicated than cleaning up the house It can be said that under the condition that the law enforcement force and the level of supervision have not changed, if we hope to strengthen the legal construction and clinical safety supervision in the short term, we will certainly from another perspective One dimension to strengthen is to enforce the law strictly, so does the crackdown, and so does this clinical audit The purpose of punishment is to regulate behavior, not only to punish Therefore, the scope and intensity of punishment of law are necessarily different in different periods, and it is not necessarily appropriate to impose severe punishment at any time Therefore, we can conclude that the biggest positive effect of similar short-term intensified punishment is deterrent But the difference of this audit is that, as director Wu Zhen said, this clinical audit is not a movement I understand this sentence as a ticket replacement in the law enforcement of the pharmaceutical regulatory system This is because the overall level of the pharmaceutical industry in China has reached a certain level, and the previous penalties have been greatly discounted in the implementation process, so the scope and intensity of the law will continue to be strengthened on this basis, so the living space of the defective enterprises will continue to be squeezed But for pharmaceutical companies, the experience of severe punishment is still applicable, that is, CFDA will pay more attention to typical cases and heavy punishment in the subsequent inspection So the next important announcement may be to announce the first batch of enterprises that have been found The author should remind that enterprises that have received clinical inspection or have major hidden dangers should be careful and careful It is really tragic to catch a typical enterprise How to prevent in the long run: centralized management is like a sprint in the long run, which is an exhausting experience for both the regulatory department and the regulated department, so many FDA preventive measures are expected to be the focus of CFDA's next management For example, CFDA introduced the blacklist system in 2012, and some provinces and cities also have their own blacklist system However, by comparing the two sides, we can find that the FDA's blacklist system has a much greater punishment According to different circumstances, the companies and individuals involved will be blacklisted Even if the ban is lifted, the blacklist will not be removed, which is equivalent to permanent occupational stain Moreover, the ban provisions of the implementation law of generic drugs are not only for the generic drug manufacturing industry, any drug application, including innovative drugs and biological products, as long as it is FDA For the products subject to approval under the jurisdiction, the applicant must submit a signed declaration stating that the prohibited person has not participated in all activities of the declared drugs A fine of up to $1 million can be imposed if a pharmaceutical company employs prohibited personnel in the form of company consultants or contract workers Banned people who work illegally in the pharmaceutical industry will also be fined up to $250000, so once they are blacklisted, their careers will be over At present, China's blacklist system is basically very kind, but with the establishment and improvement of the national credit system, the deterrent force of the blacklist system will be more and more strengthened For example 2, about 25% of the clinical trial data faced by FDA at present come from abroad, so it faces a very complex audit situation, so FDA encourages and authorizes the third-party audit institutions to participate in the clinical audit At present, our government encourages the purchase of third-party services, and third-party inspection can greatly share the energy of CFDA, which is presumably also a direction of reform For pharmaceutical enterprises, when they carry out international multi center inspection, the third party will be invited to carry out the inspection, which will greatly enhance the credibility of the data, enhance the approval rate of FDA, and also better get credit from CFDA For enterprises, the development of an industry has a process from rashness to formality Rashness is to develop rapidly at a low cost, but formality is to integrate with the world, so as to complete the industrial upgrading There is no wrong stage, and neither of the two stages is necessary Therefore, if pharmaceutical enterprises want to develop better, they should not rely on simple not to be checked However, director Wu Zhen has brought confidence to everyone He clearly pointed out that "low price is not good medicine", and good medicine is the most important, not cheap medicine For the regulatory system, prevention first and combination of prevention and treatment is not only the basic principle of curing diseases and saving people, but also a principle of treating stubborn diseases in the industry.