Cancellation of GMP certification, stricter supervision of drug production


Release time:

2017-11-01

The "the People's Republic of China Drug Administration Law" Amendment (Draft for Solicitation of Comments) proposes to cancel the drug production quality management standard certification (GMP) and the drug business quality management standard certification system (GSP), and modify the raw materials and excipients to be approved together with drugs. In this regard, observers believe that it is more difficult for pharmaceutical companies to cut corners and operate illegally by changing the heavy threshold to heavy supervision and encrypting the frequency of supervision means such as "flight inspection" in the daily production and operation of pharmaceutical companies.

The drug administration law has changed greatly, the GMP certification is canceled, and the drug number can be legally transferred for sale. A few days ago, the State Food and Drug Administration issued the Amendment to the the People's Republic of China and Drug Administration Law (draft for soliciting opinions). The General Administration stated that the revision closely focused on the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices" issued by the two offices this month, and proposed 36 reform measures.

Reporters found that the draft is reflected in the encouragement of innovation, increased penalties, from heavy entry to heavy supervision.

Drug number transferable to encourage innovation

The General Administration said that this is only a partial revision and feedback and suggestions can be made before October. The reporter noticed that this draft of the opinion clarified that the applicant who has obtained the drug approval number is the drug marketing license holder, who can produce and operate the drug by himself or entrust others to produce and operate. "The change of the drug marketing authorization holder shall meet the conditions stipulated in this Law and shall be approved by the drug regulatory department under the State Council".

In the view of industry observers, the opening of this opening means that the product number can be legally transferred, and it is no longer the iron plate of the past that cannot be loosened.

"This is conducive to accelerating market liquidity and not sticking to wasting idle drug numbers on a pharmaceutical company." In this regard, some people related to pharmaceutical companies believe that the reform of listing license holders is to activate innovation and revitalize resources. For example, scientific and technical personnel of R & D institutions can own drug registration numbers, and in this way, production and marketing licenses will be obtained. Effective separation, resource mobilization is also more flexible.

However, he also stressed that although legal trading is allowed, whether it is self-production or entrusted operation, the products must be strictly controlled from the source to the factory and after-sales, and the whole process can be traced back.

Cancellation of GMP certification and stricter supervision

The draft also proposes to cancel the drug production quality management standard certification (GMP) and the drug business quality management standard certification system (GSP), and modify the raw materials and excipients to be approved together with the drug. The draft also changed the clinical trial institution from certification to filing, the approval of drug clinical trials from express permission to implied permission, and the implementation of record management for bioequivalence trials.

In this regard, observers believe that GMP certification used to be considered as a bright license to operate, but after doing everything possible to obtain GMP certification, many pharmaceutical companies began to relax, so that every year the regulatory authorities have to spend a lot of effort to track down and revoke the GMP certificate of illegal enterprises. However, once the thinking is changed from heavy threshold to heavy supervision, and the frequency of "flight inspection" and other supervision means is encrypted in the daily production and operation of pharmaceutical enterprises, it will be more difficult for pharmaceutical enterprises to cut corners and operate illegally.

Data falsification severely banned for 10 years

The draft also places special emphasis on the requirement to implement penalties to people. Units with falsified data and revoked licenses and their directly responsible supervisors and other directly responsible personnel shall be prohibited from entering the industry within ten years; persons sentenced to fixed-term imprisonment or more for drug safety crimes shall not be engaged in drug development, production, operation, import and export activities for life.

If the drug marketing license holder, research and development unit, production enterprise, business enterprise or medical institution intentionally carries out illegal acts or has gross negligence, or if the illegal act is serious, bad in nature or causes serious consequences and other serious adverse social effects, the person in charge and other persons directly responsible shall be fined not less than 30% but not more than twice the income obtained from the unit in the previous year.

Observers said that the phenomenon of data fraud has been seriously investigated and dealt with in the past three years. As a special commodity, once the clinical data is falsified, it may cause a wide range of health risks to the population, so it must be severely investigated and punished.