Medical network - on August 2, recently, the sources said, wu zhen, deputy chief of the state food and drug supervision and administration bureau at the just concluded the food and drug supervision and administration work symposium, cancel the GMP, GCP, GLP, GSP in the future, realize the joining together of two card, no longer send certifications.
The picture shows wu zhen's speech on the reform of the pharmaceutical industry at the 8th annual meeting of Chinese medical entrepreneurs. This year, the ninth annual meeting of Chinese medicine entrepreneurs will be held in Beijing on September 22.
There has been a lot of news about the cancellation of GMP, GCP, GLP and GSP certifications, and the official version has appeared on various meetings. In December 2015, in guangdong food and drug certification technology association for the first session of the second session of the member representative assembly, the CFDA audit inspection center, deputy director of the food and drug administration Sun Jinglin said, "according to the requirements of the state council, on January 1, 2016, administration of all GMP certification authority down to the provincial bureau. GMP certification will gradually be merged with the production license, which means that GMP certification will be eliminated in the future.
But at a meeting in March this year, the CFDA official said: "in the future, the GMP and GSP, GCP, GLP no longer make specific certification, but management cannot lag, but also according to the prescribed scope inspection, production, circulation may be joining together of two card." After clarifying the concept of disqualification and "two CARDS and one". In June of this year, ding jianhua, director of the CFDA food and drug review center, made a formal request for GMP certification to cancel this concept in the form of public acceptance of media interviews.
In fact, China has always had a very Chinese characteristic in policy making: blow. Whether health reform in the basic medicine catalogue, price negotiation, or two votes, in fact, if you go back, as early as 10 years ago was put forward, a short five or six years, first in the form of blowing the scattered industry conferences, after in the form of formal rules and regulations. Today the GMP and GSP, GCP, GLP certification cancel, too, from the perspective of the process of blowing, first message to cancel, then cancelled and communicated "two card", then, in the competent leadership on informal occasions "cancel certification" is put forward. Finally, at the CFDA formal meeting, the head of the general administration formally put forward the idea of "certification cancellation" in the form of speech.
Thus, the cancellation of the "GMP, GSP, GCP, GLP" certification has passed the "blow-wind" phase and entered the formal execution level. So when does it cancel? How to regulate after cancellation?
In a year or two?
Previously, E medicine managers from the CFDA relevant personage information obtained is: "is in the revision of the pharmaceutical administration law for basic determine parts, the first is to reduce the decentralization, including generics bioequivalence for the record, traditional craft formula of traditional Chinese medicine preparation, raw materials and packaging with product registration, etc. There are no more specific certifications for GMP, GSP, GCP, or GLP.
Current under the pharmaceutical administration law of the People's Republic of China was revised in 2015, which article 9, article 14, article 30 of GMP and GSP, GCP, GLP made clear description, which requires the enterprise or institution must have related certification qualification, can operate.
However, from the speech of wu, GMP, GSP, GCP, GLP certificate of authentication must be cancelled, this inevitably involved in the pharmaceutical administration law revision work, before the completion of the pharmaceutical administration law revision, for four card cancelled and follow-up supervision, food and drug administration must be clear in advance, and relevant policy support. Therefore, from the time point, the cancellation of the four certificates and the drug administration law belong to the front and rear feet.
In march of this year, according to the epicenter wide network coverage, the National People's Congress standing committee of the pharmaceutical administration law enforcement inspection group meeting was held in Beijing for the first time, "the CFDA has begun drug management law revision work, strive for this year will be a draft amendment to the pharmaceutical administration law submitted to the state council for consideration."
This year on June 22, the 12th session of the National People's Congress, the 28th session of the standing committee of the opening jingquan revealed to the media, pharmaceutical administration law revision has been included in the 12th session of the standing committee of the National People's Congress legislative programme for five years. "A third draft of the revised draft has been formed and the draft amendment will be submitted to the state council for consideration in the second half of this year."
From the practices in terms of progress, is a step by step according to the plan implementation, so a draft amendment to the "drugadministration law strive for this year will be submitted to the state council for deliberation" target should be able to achieve, so means involving four certification cancel the problems have been solved. From this perspective, for the four certification cancelled, administration level has reached a consensus, and formulate the relevant policies, only the last issued, this time is before and after the pharmaceutical administration law revision.
And for the revision of the pharmaceutical administration law ", published in 2016 CFDA on comprehensively strengthen the food and drug administration of the regulatory system of the construction of the rule of law implementation opinion "pointed out that adhere to change waste release and, by the end of 2018, completed modification, cancellation and the food and drug industry development and supply side structural reform doesn't fit the requirements of rules and regulations, safeguard legislation and reform the decision-making, unifies, Yu Fayou according to do reform, reform in accordance with the law.
Taken together, the elimination of GMP, GSP, GCP, and GLP will be published as early as the revised drug administration law, which means that in 2018, it could be the important node for the cancellation of four certificates. On the concrete floor, E medicine managers continuous attention, wu zhen, just talk, E medicine managers interview feedback is local people in the food and drug administration, wu zhen, currently only the contents of the speech, the cancellation of the administration has not yet issued relevant certification specific files.
2. How to supervise?
How to regulate GMP, GSP, GCP and GLP certification? This is an industry concern. According to wu zhen's theory, it is "two certificates and one union". According to ding jianhua, "explore the integration of drug production quality management (GMP) certification and drug production license, and strengthen the post-mortem regulation."
As for regulatory thinking, ding pointed out that since January 1, 2016, the general administration will not accept the GMP certification application, and the GMP certification will no longer be the "umbrella" of the enterprise. "Drug GMP certification is equivalent to a five-year valid certificate for the enterprise, and even if the company does not comply with the standard production, it will assume that there is a government certification guarantee to avoid its own responsibility. Future cancelled in the form of prior certification and accreditation supervision, doesn't mean that will reduce the drug quality standard, drug firms will face more stringent inspection, not be not informed in advance of flight check."
And in the wu speech, its further clear about the supervision idea: to transform the past mainly by enterprises inspection to check varieties is given priority to, pre-ipo on-site inspection, production process of compliance and post-market supervision and inspection, will combine varieties check overall quality system effective operation, and continued compliance.
In the mode of supervision, it is suggested that the information of spot check, monitoring, price and complaint should be fully used to check the information of the problem. The inspection must be targeted and the "homework" should be done well before the inspection. In the regulatory system, it is further strengthened the linkage of inspection and inspection; On the construction of the supervisory team, the general administration is considering the establishment of a professional team of inspectors.
It is worth noting that the intensity and manner of regulatory penalties are increasing and varied. It is understood that the CFDA is making the relevant provisions of the punishment to the people, so as to combine the economic punishment, the qualification penalty, the punishment and so on, so that the various responsible subjects suspected of breaking the law are punished accordingly. From the trend of industry development, the state's illegal behavior of drug companies is entering an era of severe punishment, which is to increase the cost of crime.
From the point of the enterprise, certification cancel is imperative, and the fact that is about to fall to the ground, the enterprise needs to analyze the problems of its own in advance, to adapt to the upcoming dynamic regulation, of course this is one of the most important attitude adjustment, keep up with the pace of the CFDA on philosophy.
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