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BACKGROUND: On July 4, 2021, China officially introduced the drug patent linkage system, which has made more localized adjustments than have similar systems in the US and South Korea. This study describes the characteristics and outcomes of China's patent linkage system. METHODS: For this study, we used the database of China's patent information registration platform for marketed drugs to capture all listed patents and patent certifications from June 25, 2021, to June 30, 2023. We used descriptive statistics for the above data to assess the impact of patent linkage on branded drug manufacturers, generic drug manufacturers, and the public's access to medicines. RESULTS: During the study period, the patents of 632 branded drugs were listed, and 5058 ANDAs submitted patent certifications to the Registration Platform. Of these 632 branded drugs, 462 (73.1%) drugs were approved before the year of patent registration, and the average number of listed patents per drug was 1.8, with a standard deviation of 1.4. However, of these 5058 ANDAs, P1 certifications accounted for 85.1%, and P3 and P4 certifications accounted for 16% combined. In addition, according to the detailed statistics of P2 certifications, we found that the proportion of patent invalidation cases was 46.4%. The remaining validity of the patents corresponding to P3 certifications was longer, with a median value of 17 months, and the IQR was 10-30.75, ranging from - 2 to 204 months. CONCLUSIONS: China's patent linkage aims to promote the balance of multiple interests -innovation, imitation and public health-and has its own system characteristics. Patent listing and patent certification are the key indicators reflecting the implementation effect of the system. From the perspective of system outcomes, ANDAs have been connected to the patent linkage system in an orderly manner, but the growth of patent challenges is not obvious. Moreover, manufacturers of foreign branded drugs that have not yet entered the Chinese market need to pay more attention to the role of patent listing.
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Medicamentos Genéricos , Internacionalidad , Humanos , República de Corea , ChinaRESUMEN
PURPOSE: Our aim was to characterize the newly established new drug conditional approval process in China and discuss the challenges and opportunities with respect to new drug research and development and registration. METHODS: We examined the new approval program through literature review, law analysis, and data analysis. Data were derived from published materials, such as journal articles, government publications, press releases, and news articles, along with statistical data from INSIGHT-China Pharma Databases, the China Food and Drug Administration website, the Center for Drug Evaluation website, the US Food and Drug Administration website, and search results published by Google. FINDINGS: Currently, there is a large backlog of New Drug Applications in China, mainly because of the prolonged review time at the China Food and Drug Administration, resulting in a lag in drug approvals. In 2015, the Chinese government implemented the drug review and registration system reform and tackled this issue through various approaches, such as setting up a drug review fee system, adjusting the drug registration classification, and establishing innovative review pathways, including the conditional approval process. IMPLICATIONS: In Europe and the United States, programs comparable to the conditional approval program in China have been well developed. The conditional approval program recently established in China is an expedited new drug approval process that is expected to affect new drug development at home and abroad and profoundly influence the public health and the pharmaceutical industry in China. Like any program in its initial stage, the conditional approval program is facing several challenges, including setting up a robust system, formatting new drug clinical research requirements, and improving the regulatory agency's function for drug review and approval. The program is expected to evolve and improve as part of the government mandate of the drug registration system reform.