Drug Administration to Cancel Approval of GMP and GSP Certification-Zhejiang Jianfeng Pharmaceutical Co., Ltd.

Drug Administration to Cancel Approval of GMP and GSP Certification

Release time:

2017-11-01

What is the impact of the proposed cancellation of GMP and GSP certifications, which are regarded as important guarantees of drug quality, on the safe use of drugs by the industry and the public? On October 23, the State Food and Drug Administration issued the Amendments to the (the People's Republic of China Drug Administration Law) (Draft for Comments), which is open to the public for comments by the 30th of this month. In order to implement the requirements of "release, management and service", the amendment proposes to cancel the two major certifications of good manufacturing practice (GMP) and good management practice (GSP), and at the same time liberalize the management of license holders. Industry insiders pointed out that the cancellation of GSP and GMP certification is only loosened from administrative examination and approval, and enterprises still need to follow quality standards and achieve compliance. This also means that there will be a more rigorous quality management system to replace the previous certification management, which is a "good thing" for the quality of drugs and the research and development of new drugs ".

[revision]]

　　GMP、GSPCertification will be canceled

The reporter noted that the draft for soliciting opinions pointed out that Article 9 of the Drug Administration Law was changed to Article 10, and the first paragraph was revised to read: "Drug manufacturers must organize production in accordance with the" Drug Production Quality Management Standards "formulated by the drug supervision and administration department of the State Council in accordance with this law"; the first paragraph of Article 16 is amended to read "Pharmaceutical trading enterprises must deal in pharmaceuticals in accordance with the" Pharmaceutical Trading Quality Management Standards "formulated by the pharmaceutical regulatory authority under the State Council on the basis of this Law".

The two new provisions delete the original "the drug supervision and administration department shall certify whether the drug trading enterprise meets the requirements of the" Drug Business quality Management Standard "in accordance with the regulations; if the certification is qualified, a certification certificate shall be issued" and "the drug supervision and administration department shall certify whether the drug production enterprise meets the requirements of the" Drug production quality Management Standard "in accordance with the regulations; if the certification is qualified, a certification certificate shall be issued. This means that the traditional GMP and GSP two major certification will be canceled.

Drug number can be legally transferred

At the same time, the draft clearly pointed out that the full implementation of the drug marketing license holder system. The applicant who has obtained the drug approval number is the holder of the drug marketing license. He can produce and sell the drug by himself or entrust others to produce it, and bear legal responsibility for the whole cycle of the drug. This also means that the batch number of the drug is no longer tightly tied to the production, and the product number can be legally transferred.

The State Administration of Food and Drug Administration pointed out that the revision of the Drug Administration Law is in response to the "on deepening the reform of the examination and approval system to encourage drugs" issued by the two offices on October 1.Medical DevicesThe 36 important reform measures proposed in the "Innovative Opinions" have been revised and improved to match the smooth implementation of the innovative opinions.

[Interpretation]]

Drug quality management practices will be "upgraded"

"Behind the cancellation of GSP and GMP certification is the upgrade of a set of quality management standards." Industry insiders told reporters. In fact, for the cancellation of these two certifications, the regulatory level has been "blowing wind" for a long time.

In March this year, the relevant departments of the state have clearly stopped GMP certification fees. Wu Zhen, deputy director of the State Food and Drug Administration, proposed at the National Food and Drug Administration Symposium that GMP and GSP will be gradually abolished in the future, integrated into an administrative license, and no certification certificate will be issued. He revealed that to put the past by inspectionEnterpriseThe main change to inspection varieties, change the practice of heavy examination and approval, light supervision, strengthen supervision and inspection and weaken licensing approval.

In general, the idea of regulatory approval is changing from "strict entry and wide exit" to "lenient entry and strict exit.

Farewell to "the most stringent certification" ≠ regulatory deregulation

Over the years, GMP certification and other methods have been regarded as a weapon to regulate the small, scattered and chaotic conditions of domestic pharmaceutical companies. In 1998, China first introduced GMP certification with reference to international standards, and put forward clear requirements for various production links such as factory buildings to the ground, equipment, personnel and training, sanitation, air and water purification, and emphasized that all drugs must not be certified. production.

A few years ago, the new version of GMP landed again. The hardware part referred to the relevant EU standards and the software part referred to the relevant FDA standards in the United States. It was called "the most stringent certification in history" in the industry. All manufacturers were required to reach the new version of GMP certification before December 31, 2015. As a result, thousands of pharmaceutical companies are "hanging by a thread".

Once the GMP certification is canceled, does it mean that the production threshold for pharmaceutical companies is lowered? Industry insiders say that the cancellation of administrative certification will not lower drug quality standards, but pharmaceutical companies will face more normalized and stringent inspections.

"In the past, drug GMP certification was equivalent to awarding a five-year valid certificate to a company, and even if the company did not produce in accordance with the specifications, it often circumvented its own responsibilities because it had the qualifications to be certified by the government. In the future, after the elimination of supervision in the form of prior certification, pharmaceutical companies will face more stringent inspections of all kinds, especially unannounced flight inspections." Shi Huida Pharmaceutical Group general manager Liu Fengjiang said in an interview with reporters.

The reporter learned that the Food and Drug Administration has no longer accepted applications for GMP certification since January 1, 2016.

Conducive to drug safety and industry innovation

Cheng Jinle, chief engineer of Zhongzhi Pharmaceutical Group, pointed out that the revision of the Drug Administration Law has reduced the administrative examination and approval links of pharmaceutical enterprises, reduced administrative costs, and is generally conducive to the innovative development of the industry and the drug safety of residents.

"The abolition of GMP, GSP certification and the implementation of the drug marketing authorization holder system are mutually reinforcing." Liu Fengjiang pointed out that in the past, drugs were bound to GMP-certified pharmaceutical companies before application. The cancellation of certification enabled pharmaceutical companies to apply for new drugs before entrusting any qualified pharmaceutical company to process and produce them. This is of great significance in encouraging the research and development of drugs.

"From the perspective of the deepening of the reform of the administrative examination and approval system, a set of supporting systems that encourage drug research and development and innovation are gradually improving." Industry insiders pointed out.

Main contents of revision

1. Full implementation of the drug marketing authorization holder system

　　DrugsThe applicant with the approval number is the drug marketing authorization holder;

The holder of the drug marketing authorization shall bear the legal responsibility for the safety, effectiveness and controllable quality of the drug;

The drug marketing authorization holder is responsible for preclinical research, clinical trials, production and operation of the drug,Adverse reactionThe report shall bear all legal responsibilities;

The holder of the overseas drug marketing license shall also appoint an agent to jointly bear the legal liability.

2. Implementing the requirements for the reform of the administrative examination and approval system

Change clinical trial institutions from certification to filing, change drug clinical trial approval from express permission to implied permission, and implement filing management for bioequivalence trials;

Cancellation of Good Manufacturing Practice (GMP) and Good Pharmaceutical Management Practice (GSP) certification;

Modification of APIs and excipients to be approved with the drug product

3. Increase the establishment of a professional drug inspector system

Inspectors should have drug lawsRegulationsand professional knowledge, and can only engage in inspection work after passing the examination;

The drug supervision and administration department of the State Council shall implement hierarchical management of professional drug inspectors and establish incentive and restraint mechanisms such as assessment, salary and promotion.

4. Implement the punishment to the person's request

Units that have falsified information and data and whose licenses have been revoked, as well as their directly responsible supervisors and other directly responsible personnel, shall be banned from entering the industry for 10 years;

Persons who have been sentenced to fixed-term imprisonment or more for drug safety crimes shall not engage in drug research, production, marketing, import and export activities for life

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