In 2009, Fast Approval by the CFDA — a fast approval process for drugs to treat several rare diseases — was implemented. A separate regulation specifies that drugs to treat rare diseases can fulfil fewer clinical trial requirements (8). Shanghai model: The Shanghai Rare Disease Society, founded in early 2011, also works to promote legislation, research, and insurance coverage for rare diseases. Over the past several years, the City of Shanghai has covered medical costs for treatment of 12 specified rare diseases (8). Qingdao model: In 2012, Qingdao, a coastal city in Shandong Province, approved a proposal to cover a capped amount of the treatment fees for all diseases, including rare diseases (8). In 2013, the China Rare Diseases Prevention and Treatment Alliance was established. The Alliance launched China's first pilot project at the national level to promote better healthcare for rare diseases. The Alliance established a national collaborative network involving more than 100 provincial and municipal medical facilities to implement this project. This network covers 13 provinces, which have a population of 0.7 billion (6,8) In January 2016, a National Committee of Experts on Rare Disease Treatment and Prevention was established under the leadership of the National Health and Family Planning Commission of the People's Republic of China in order to improve the management of rare diseases, to promote the standardization of diagnosis and treatment of rare diseases, and to ensure the basic medical needs of patients with a rare disease are met and their right to health is upheld (7). At the end of 2015, the CFDA announced that it would prioritize the review of new technologies and novel therapies for AIDS, tuberculosis, viral hepatitis, rare diseases, and cancer, and particularly for medicines developed for pediatric or elderly patients (9). In March 2016, the Ministry of Science and Technology of the People's Republic of China issued Guidelines for 2016 National R&D Programs Focused on Precision Medicine and other Key Projects (10). |
