China's State Council has approved the launch of a pilot programme to allow innovative pharmaceutical firms and smaller companies to apply for marketing approval from the China Food and Drug Administration (CFDA), despite the absence of in-house manufacturing capabilities, according to Chinese-language statements (available here and here).
Implications | The new pilot programme aims to expand eligibility for marketing authorisation holders (MAH) to individual researchers as well as smaller companies that use contract manufacturing organisations (CMOs) to manufacture drugs. |
Outlook | The approval of the pilot programme outlined by the State Council in late 2015 is expected to significantly reduce barriers to obtaining MAHs for China's innovative researchers and research firms by reducing costs related to in-house drug production. |
The new pilot programme aims to expand eligibility for marketing authorisation holders (MAH) to individual researchers as well as smaller companies that use contract manufacturing organisations (CMOs) to manufacture drugs. According to the statements, China's State Council has approved the pilot programme in 10 provinces and cities: Beijing, Shanghai, Tianjin, Hebei, Guangdong, Jiangsu, Zhejiang, Fujian, Shandong, and Sichuan.
The pilot programme will run until 4 November 2018, and individual MAHs must hold Chinese citizenship. In addition, some medications are excluded from the pilot scheme. Applicants in the pilot regions are permitted to file applications for clinical trials or marketing-authorisation registration, with successful applicants now allowed to hold legal responsibility for clinical studies, manufacturing, and marketing of the treatments.
According to the State Council's statement, treatments eligible for MAH trials include:
Drug Class | Details |
|---|---|
Therapeutic biologics class 1 | Biologics not previously marketed outside or within China |
Therapeutic biologics class 7 | Biologics previously marketed outside China but not within China |
Traditional Chinese medicine and natural drugs | Classes 1–6 |
Biosimilars | |
Chemical drug classes 1–4 | |
Chemical drug class 5 | Preparations that change formulation of marketed drugs but not administration route |
Chemical drug classes after introduction of new chemical-registration classification system | |
Approved generics with quality and efficacy consistent with originators | Includes chemical drugs classes 3–4 after the new chemical-registration classification |
Domestic drugs, (i) referencing originator drugs marketed outside China but not within China, and (ii) consistent with the originator drugs in quality and efficacy | |
Domestic drugs, (i) referencing originator drugs already marketed within China, and (ii) consistent with the originator drugs in quality and efficacy | |
Source: China State Council; China Food and Drug Administration (CFDA), 2016 | |
Outlook and implications
The State Council's approval of the pilot programme is expected to significantly reduce barriers to obtaining MAHs for China's innovative researchers and research firms, through alleviating the costs related to in-house drug production. The approval of contract manufacturing is a novel development in China, and is expected to allow both domestic and overseas firms to make use of less costly manufacturing arrangements. Overall, the pilot programme aligns with China's strategy of boosting local innovation and enabling a shorter time to market for innovative drugs. The approval follows the State Council's announcement late in 2015 that it would allow smaller, research and development (R&D)-focused firms to apply for marketing approval for new drugs through a separate channel than for manufacturing licences (see China: 6 November 2015: China launches pilot scheme to facilitate new drug approvals). In addition, the pilot programme is expected to serve as a further deployment of the Chinese authorities' attempts to shorten the country's drug-approval backlog.
While the pilot programme is expected to provide added stimulus to China-based innovative research firms, it is also expected to stoke further growth in the CMO industry in the Asia-Pacific market, which is already the world's fastest-growing region and forecast to grow at a compound annual growth rate (CAGR) of over 7.5% until 2020 (source: Research and Markets).