Director of the General Administration of Food and Drug Administration: GSP certification will be completely abolished


GMP leader: certifications will all be canceled

"GMP and GSP certifications will all be canceled." On September 24, at the 2017 China Pharmaceutical Entrepreneur Scientist Investor Conference held in Beijing, Ding Jianhua, director of the regulatory department of the General Administration of Food and Drug Administration, said.

From the industry has a call to the General Administration of officials in the General Assembly voice, the full abolition of the GSP certification of the news was solidified.

In the main meeting of the conference's policy innovation, Ding Jianhua expressed the abolition of GMP, GSP certification after the regulation and the relationship between business: "defective is true, 100% perfect is false. The shift from certification to inspection is a challenge for both enterprises and us. Our future relationship with the enterprise is, I am not a policeman, you are not a thief, we are a partnership, only work together the final goal can be achieved, otherwise it will not work."

GMP/GSP is the minimum requirement, flying inspections will be more frequent

As early as November 2014 at the 26th National Pharmaceutical Economic Information Conference, Wu Liya of the Department of Legal Affairs proposed in the report "Introduction to the Revision of the Drug Administration Law" that the drug GMP and GSP certification system should be gradually decentralized and abolished, and that the certification system should be combined with the access standards for pharmaceutical companies and the supervision of daily production and business practices, so as to reduce the approval of supervision and strengthen the daily supervision and inspection Strength.

At the meeting on September 24, Cyberland - pharmacy manager (WeChat ID: yaod366) with such a question to Ding Jianhua: after the abolition of GMP / GSP certification, does it mean that the future of the regulation is more stringent, more frequent flight inspection?

He jokingly asked rhetorically, "Why do you want to cancel, how many people agree to cancel, raise your hand."

Many people raised their hands in favor of abolition. Someone replied, "I want to cancel because the certification process is too troublesome..." a sentence that caused the conference hall to burst into laughter.

At the same time, some people on the spot suggested that it was better to keep the certification, so that enterprises could have a standard to do and use it as a guideline.

And Ding's answer was clear and concise: "Those who think it should be canceled, and those who think that after the cancellation, the drug regulatory authorities will finally not come to check on me (you must have dreamed of doing more), on the contrary, there will be more checks, and the checks will be more scientific."

"GMP/GSP is the floor (should not be seen as a very high standard ceiling), is the minimum standard, is the minimum requirements, so do not need certification."

In fact, the objective reason for not needing certification is that not many companies used to be able to meet the GMP/GSP standard, and now that everyone is doing so, that standard has been surpassed. It's like before you can eat white bread is a luxury, but now everyone can eat bread.

Therefore, GMP/GSP has become the most basic, the minimum requirements of the configuration.

There is no need to give a good man to issue a "good man card", he will do a good job!

An undeniable fact is that the pharmaceutical industry in China for nearly 20 years to tell the development, if there is no GMP / GSP, no corporate efforts, the current level of the pharmaceutical industry by no means reach the current level. And development means change, so the concept of GMP, GSP need to change. Cancel the two certifications, is one of the embodiment of this "change".

For example, at present, many drug manufacturers is the concept of selling drugs to one, two or three wholesalers, it has nothing to do with their own; or, through the GMP certification and inspection is equal to the medicine to eat the tube.

"A lot of did not connect product quality with patients, and what is the purpose of making medicine, in order to cure the disease." Ding Jianhua, director of the Division of Food and Drug Administration made a very graphic analogy: "GMP (including GSP) should be the floor rather than the ceiling, there is no need to give good people to issue a "certificate of good people" (to prove that he is a good person), the good people are supposed to be, in accordance with GMP specifications are supposed to be. "

GSP certification should not be like the university, excited, "sheep" for four years!

In accordance with the above metaphor can be analogized: there is no need to give retail pharmacies issued through the GSP certification certificate, so as to prove that he sells drugs are qualified. Qualified is supposed to be, the most basic requirements, rather than the certification of the time of the moment qualified, after the fact is not known. This is the current retail pharmacy should have the concept.

It's like taking a college exam. Three years of hard study in high school, once the examination into the ivory tower of the university, relax their own or even desert their studies, thinking that into the university will be fine. Although in the end to get a diploma, but do not feel the weight of it, in fact, because they even will be admitted to the university as a ceiling general standards.

In fact, really not certified after the enterprise's worry will be more, because I do not know which day to check, you have to do a good job every day, it is unlikely that one day to check on your head.

Compared to before, the enterprise's responsibility is greater, is a good thing more conducive to business growth. Instead of today's inspection, tomorrow a long sigh of relief, the chairman of the evening to say treat dinner and bonuses, and then scattered, 5 years and do not care.

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