Drug quality consistency evaluation

There is indeed a large gap between the quality of generic drugs in my country and the original research drugs. At present, most of the domestic production of generic drugs refers to incomplete and irregular standards, and some are produced in accordance with the standards of other generic drugs, which are different from the original drugs in terms of safety and effectiveness. Big gap. The pharmaceutical industry estimates that more than 70% of domestic generic drugs have a gap between the efficacy of the original drugs. In terms of treatment, the risk of side effects of generic drugs is far greater than that of original drugs. For example, the generic drug ampicillin, even if the penicillin skin test is negative, you must be highly alert to the possibility of drug eruption; there are also some generic antifungal drugs, which have more toxic side effects such as skin rash and damage to the kidney and liver than the original drug. high.

In order to improve the quality of my country's national defense drugs, the state has successively issued a series of notices, announcements and guidelines on the consistency of the quality and efficacy of generic drugs since 2012.

2012.1-The State Council issued the "Notice on Printing and Issuing the National Drug Safety "Twelfth Five-Year Plan"", formally proposing that the generic drugs approved before the implementation of the "Administrative Measures for Drug Registration" revised in 2007 will be issued in phases in the next 10 years. Evaluation of quality consistency between batches and generic drugs;

2012.4-The National Bureau organized a delegation to study in Japan, and combined with the situation in the United States, it was determined that "using multiple in vitro dissolution profiles to carry out the consistency evaluation of the generic drugs for oral solid preparations on the market in my country";

2012.11—The State Administration issued a notice on the "Work Plan for Quality Consistency Evaluation of Generic Drugs (Draft for Comment)" (Shiyao Jian Zhuhan No. 227), and formulated drafting instructions;

In 2012, the “Office for Quality Consistency Evaluation of Generic Drugs” was established, located in China Food and Drug Control Research Institute, responsible for the specific implementation and technical review of the quality consistency evaluation of generic drugs, and the consistency of a variety of drugs has been released Discuss evaluation methods and solicit opinions;

2013.2-The State Administration issued a notice on the quality consistency evaluation of generic drugs (Guo Shi Yao Jian Note No. 34), proposing the importance of consistency evaluation, publicizing policies, advocating enterprises to take the initiative, and formulating work plans and goals , Principles, content and plans, and strive to complete the formulation of methods and standards for the comprehensive quality consistency evaluation of the essential medicines catalog in 2015;

2013.7-The State Administration issued the "Notice on the Research Tasks of the Quality Consistency Evaluation Method for Generic Drugs in 2013" and the "Summary of List of 75 Varieties and Methods Research Undertaking Units";

2014.1-The National Bureau issued a public solicitation of opinions on the guidelines for the quality consistency evaluation of generic drugs, and plans to publicize the evaluation methods and 2 technical guidelines for the 3 varieties to be evaluated;

2014.3—In the spirit of the 2015 National Drug Registration Management Working Conference, it was proposed to steadily promote the quality consistency evaluation of generic drugs, initiate declaration, acceptance, production site inspection and review, etc., and allow generic drugs that passed the consistency evaluation to be included in the instructions It should be marked on the label and support in clinical application, bidding and procurement, medical insurance reimbursement, etc.; the name of the standard drafting enterprise is marked in the National Pharmacopoeia;

2015.7—The National Bureau issued an announcement (No. 140 of 2015) on soliciting policy opinions on accelerating the resolution of the backlog of drug registration applications, stating that if the original research drug has not yet been approved for marketing in China, it shall be approved conditionally according to the original standard, and the enterprise shall 3 The consistency evaluation with the original drug must be passed within the year, and the drug approval number will be cancelled at that time;

2015.8-The State Council issued an opinion on reforming the review and approval system for drugs and medical devices (Guo Fa [2015] No. 44), proposing to improve the quality of generic drugs, speed up the quality consistency evaluation of generic drugs, and strive to complete the national essential drug oral preparations by the end of 2018 Evaluate the quality consistency with reference preparations; propose green channels, speed up review and approval, and conduct pilot work; further clarify various encouraging policies.

2015.10-The State Food and Drug Administration issued the "Opinions on Carrying out the Quality and Efficacy Consistency Evaluation of Generic Drugs (Draft for Comment)" on the consistency evaluation of generic drugs, and successively issued the "Implementation on Resolving the Backlog of Drug Registration Applications" Opinions on Priority Review and Approval (Draft for Solicitation of Comments), "Announcement on Several Policies for Drug Registration Review and Approval of the State Food and Drug Administration and the State Food and Drug Administration", "Guiding Principles for Selection and Determination of Reference Preparations for Oral Solid Preparations (Solicitation) Opinion Draft), “Guiding Principles for the Determination and Comparison of Dissolution Curves of Oral Solid Preparations (Draft for Comment)”, “Technical Guidelines for the Evaluation of Human Bioequivalence of Generic Drug Quality Consistency (Draft for Comments)” and other series of documents.

2016.2-The General Office of the State Council issued the "Opinions of the General Office of the State Council on Carrying out the Consistency Evaluation of the Quality and Efficacy of Generic Drugs".

Chen Hao, a researcher at the Center for Drug Policy and Management of Tongji Medical College, Huazhong University of Science and Technology, said: "Our national drug number covers more than 38,000 drug varieties and more than 89,000 drug product regulations, of which 55% are chemical drugs. There are 520 varieties of medicines. Before 2018, about 3,000 of China’s nearly 5,000 pharmaceutical companies will be facing severe industry integration inflection points."

At 3 pm on February 29, 2016, the State Council Information Office held a press conference on food and drug safety issues. Bi Jingquan, Director of the State Food and Drug Administration, discussed the electronic supervision code, drug review, self-examination verification, children’s medicine, Questions such as the consistency evaluation of generic drugs were answered by reporters.

People's Daily reporter: "I have noticed that EU countries encourage the use of generic drugs, and there are corresponding policies. I have noticed that the General Administration is requesting companies to conduct consistent evaluations of the efficacy of generic drugs. I would like to ask why this measure is implemented in my country? What is the corresponding support policy? Thank you."

Bi Jingquan: "The consistency evaluation of the quality and efficacy of the generic drugs that have been approved for marketing is a lesson in history. Because the drugs we approved for marketing in the past did not have mandatory requirements for the evaluation of the quality and efficacy of the original drugs, so some There is some gap between the efficacy of drugs and the original research drugs. The gap between the drugs approved for marketing before 2007 is even greater. You all know the stories that happened in that era. In history, the United States, Japan and other countries have also experienced the same process. Japan uses It took more than ten years to advance this work. The consistency evaluation of quality and efficacy requires that the quality and efficacy of the generic drugs that have been approved for marketing should be consistent with the original drug in terms of quality and efficacy, and they can be replaced by the original drug in clinical practice. This is conducive to saving social medical expenses. On February 20, the General Office of the State Council has officially issued the "Opinions on Promoting the Quality and Efficacy Consistency Evaluation of Generic Drugs", which has made arrangements for this work. Contents of the following aspects:

1. The main body of the consistency evaluation is the enterprise, and the enterprise should actively look for product reference preparations, research and conduct clinical trials according to the prescribed methods.

2. The government should coordinate the confirmation and evaluation methods of product reference preparations, as well as data declaration and evaluation, and provide guidance for this work.

3. Policy support should be given in terms of clinical use and medical insurance.

Fourth, we have clarified the time point. Before the end of 2018, complete the consistency evaluation of the oral solid preparations of chemical drugs in the National Essential Drug List approved before the implementation of the new drug registration measures on October 1, 2007. At that time, if the evaluation is not passed, the drug approval number shall be cancelled. For other drugs that have been approved for marketing, after the first product passed the consistency evaluation, if the same product of other manufacturers fails to pass the evaluation within 3 years, the drug approval number shall be cancelled. This is also a huge challenge for enterprises, but this work will improve the quality of the development of the pharmaceutical industry, and truly transform our country’s pharmaceutical industry from a major pharmaceutical country to a powerful pharmaceutical country, and truly enable the preparations and drugs we produce to enter the international market. , Are all crucial. "

Our company focuses on the production of anti-tuberculosis chemical drugs, and has included a number of related varieties in the 2012 edition of the Essential Drug List. At present, related work on the consistency evaluation of isoniazid tablets, rifampicin capsules and pyrazinamide tablets has been launched one after another. In order to ensure the smooth progress of the quality consistency evaluation work, a consistency evaluation working group was established. With the cooperation of our company’s quality system, production system, and procurement system, as well as the assistance of the group’s research institutions, the consistency evaluation work is proceeding intensively and orderly, striving to complete the quality of each product in the plan before the deadline required by the state Consistency evaluation work.

"Generic Drug Quality Consistency Evaluation" is a work that benefits the country and the people. It plays an irreplaceable positive role in comprehensively improving the quality of my country's generic drugs, improving the overall level of the industry, and promoting domestic enterprises to participate in international competition. At the same time, the evaluation of the consistency of generic drugs is also a comprehensive, complex, long-term and challenging task. Through the consistency evaluation work, we will continue to improve the preparation technology of our country's drugs and the quality of generic drugs, establish related databases, ensure the safety of public use of drugs, and improve the international competitiveness of the pharmaceutical industry, so that we dare to use and are willing to use local generic drug manufacturers. Generic drugs produced.