Breaking through the bottleneck, solving the problem, the consistency evaluation of generic drugs is steadily advancing

The consistency evaluation of generic drugs is tight and the task is heavy. The State Food and Drug Administration has accelerated research and development of technical guidelines for conformity assessment, expanded clinical trial resources, coordinated implementation of relevant incentive policies, and earnestly studied and resolved the problem of reference preparations, and steadily promoted the evaluation of generic drug conformity.

Forming an expert committee to promote evaluation work

In August 2015, the State Council issued the “Opinions on Reforming the Examination and Approval System for Pharmaceutical Medical Devices”, requesting the evaluation of the consistency of generic drugs; in February 2016, the General Office of the State Council issued the “Consensus on the Evaluation of the Quality and Efficacy of Generic Drugs”. Opinions, further clarifying the relevant requirements such as the time limit for completion. In February this year, the State Council issued the "13th Five-Year National Drug Safety Plan", reaffirming the further improvement of drug quality, and approval of the listed generic drugs should be consistent with the quality and efficacy of the original drug.

In accordance with the overall deployment of the State Council, the State Food and Drug Administration has comprehensively deployed the consistency evaluation work. In November 2015, the Office of Quality and Efficacy Consistency Evaluation of Generic Drugs was established to study and formulate work plans, refine work procedures, and prepare and transform one. The series of technical guidelines, currently published 10 policy documents and 5 technical guidelines. At the same time, a committee of conformity evaluation experts composed of 66 experts including Academician Sang Guowei was formed. The training lecturer group consisted of the Department of Pharmacy Registration, the Central Inspection Institute, the Pharmacopoeia Commission, the Drug Examination Center, and the Audit and Inspection Center. Conduct roving training, interpret national policies, and promote the evaluation of generic drug consistency.

The reference preparation was introduced to speed up the "congestion lake"

The consistency evaluation of generic drugs is a pioneering work in China. According to the relevant requirements, the consistency evaluation of 289 chemical generic drug oral solid preparations should be completed before the end of 2018; in order to simplify the import approval of reference preparations, the General Administration issued Announcement on matters related to the one-time import of comparative drugs for research in the development process.

The relevant person in charge of the Office of Conformity Evaluation of the General Administration said that the enthusiasm of enterprises to participate in the consistency evaluation is very high. In 2016, the Office of Consensus Evaluation of the General Administration accepted more than 4,000 applications for reference preparation and more than 700 records. Among them, Jiangsu, Guangdong, Shandong, Zhejiang, Shanghai and Beijing have more applications for filing, more than 300. As of the current statistics, the number of 289 varieties filed is about 2,600, accounting for about 50% of all filing applications; the number of varieties of 289 varieties is about 28% of the total number of records.

The number of filings for enterprise reference preparations has increased dramatically, and a “block lake” has been formed. In 2017, the General Administration will continue to focus on improving the quality of medicines, speed up the evaluation of the consistency of generic drugs, and actively solve the problem of reference preparations. On the one hand, the pace of the introduction of reference preparations will be accelerated, and all the original drugs that have been patented or data-protected in China will be included in the reference preparations. For the original research enterprise to stop production, the generic drugs that are approved to be listed in the European Union, the United States or Japan and listed as reference preparations may be included in the reference preparation. The Office of Conformity Evaluation of the General Administration will put forward a list of 289 kinds of original research enterprises that need to be completed before the end of 2018, and make them available to the public for reference when selecting the reference preparations.

Some enterprises have reported that the choice of reference preparations is more complicated, some are listed abroad, some are not listed abroad, some of the original research enterprises have stopped production, and some can not find who the original research is. Enterprises are more confused about the choice of reference preparations. In this regard, the General Administration will gradually establish a catalogue of reference preparations, and has now released a total of 84 specifications for the two batches of generic reference preparations. In addition, companies are encouraged to choose their own reference preparations. The reference preparations filed by the enterprise newspapers and general bureaus are all disclosed to the public, and the bureau's consistency evaluation office proposes classified guidance opinions, which are determined by the enterprises themselves and bear corresponding responsibilities.

Numerous clinical institutions assist BE trials

At present, enterprises generally reflect that medical institutions are unwilling to undertake bioequivalence tests (hereinafter referred to as “BE test”). Even if they are willing to carry out tests, the high cost will make the company discouraged. The lack of clinical trial institutions and low willingness have become the bottleneck restricting the implementation of consistency evaluation.

The reporter learned that in order to solve this problem, some provinces and cities have adopted government financial subsidies to guide local production enterprises to carry out the evaluation of generic drug consistency. Recently, Jinan City issued the "Special Policy for Encouraging the Consistency Evaluation of the Quality and Efficacy of Generic Drugs", and the maximum amount of reward funds for a single variety is 4 million yuan.

The relevant person in charge of the Pharmacy Registration Department of the General Administration said that in order to further enrich the BE test resources, the SIPO has recently completed on-site inspections of more than 100 new clinical trial institutions. After the completion of the qualification assessment in May, the medical institutions with the ability to conduct BE tests will be More than 600.

The General Administration of the People's Republic of China actively promoted more clinical trial institutions to participate in the BE trial. It has jointly identified four medical institutions in Taiwan for drug clinical trials, conducted on-site inspections of new drug clinical trials in three hospitals in Hong Kong, and actively explored. Resources such as medical institutions, institutions of higher learning, and scientific research institutions with conditions are put into clinical trials. At the same time, the General Administration will further promote the qualification of drug clinical trial institutions from examination and approval to filing management.

The "Orange Book" system guides the orderly declaration

It is an urgent task to establish a catalogue of listed drugs in China, namely the "Orange Book". Drawing on the international common practice, combined with China's national conditions, the new drug and generic drug varieties and their reference preparation information approved for listing after the new registration are publicly disclosed, which is conducive to guiding and encouraging the orderly research and development and registration of generic drugs.

The relevant person in charge of the Pharmacopoeia Committee said that the establishment of a catalogue of listed drugs in China and the establishment of a recognized benchmark for drug reference preparations will help R&D companies to quickly inquire about reference drug information, understand product listings, serve generic drug research and development, and declare; The patient inquires, prescribes, selects, and uses the drug; it is convenient for the drug supervision department to master the drug information, which is conducive to drug supervision and information disclosure after listing.

According to reports, the current establishment of the "Orange Book" is being accelerated in stages and steps. The procedures for selection of reference preparations, expert review and list determination have been stipulated, and 289 varieties have been completed in the American and Japanese Orange Book. Compared with the analysis, sorting and determination of the preparation of the preparations, a communication meeting was held between 289 varieties of reference preparations and the original research enterprises.
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