Abstract
China’s Food & Drug Administration has disclosed draft rules that could significantly simplify the process that foreign drug manufacturers must go through to register their products. At present, new drugs are often launched in China years after they are available in other countries. China is the world’s second-largest drug market but one where foreign firms have struggled with regulations on new products, according to the U.S. International Trade Administration. Worth $108 billion in 2015, the Chinese pharmaceutical market will grow to $167 billion by 2020, the agency expects. Outlined in a document less than one page long, the proposed reform notably discusses doing away with a requirement for foreign firms to delay their clinical trials in China until after they have initiated Phase II clinical trials of a drug’s effectiveness in another country. In addition, foreign manufacturers would not have to undertake country-specific clinical trials in China, as long as
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