China's State Council announced that under new rules designed to speed the approval of drugs, data from clinical studies conducted outside the country can be used to support marketing applications for medicines. The proposal removes the need for companies to undertake additional trials in China.
"We want to make our drug industry large-scale and strong, make it more competitive, and shift our long-term reliance on imports of new drugs," remarked Wu Zhen, deputy head of the China Food and Drug Administration. "(Some drugs) have been used overseas for 6-7 years before making it to market in China," Wu added.
Commenting on the news, ICBC International Research analyst Jialin Zhang said "for multinational and leading local innovative drugmakers, the anticipated acceleration of approval will improve patients' access to new medicine and increase revenues for pharmaceutical companies." Jialin suggested that in the short term, foreign drugmakers will be the prime beneficiaries as they're already starting to see faster approvals for their drugs and have well stocked pipelines of medicines in development. However, the analyst noted that domestic drugmakers might be bigger beneficiaries over the long-term due to expertise in the local market and cheaper costs.
The proposals noted that "overall, China's support for scientific innovation with drugs…is lacking, and the quality of products on the market still falls short of top international levels." The proposal added "we must speed up the examination and approval of urgently needed drugs."
The State Council also said it would look to improve the protection of medical intellectual property and increase the number and quality of clinical trial testing centres in China. In addition, the proposals include exploring a new system linking drug approvals to patent status, which could potentially delay the introduction of generics when there are legal challenges filed by the patent holder. Wu remarked that China's protection of intellectual properties is still lacking, "and this is also an important reason that restricts the development of our medical innovation industry."
In March, China proposed ways to speed up approvals for imported drugs, including reforming clinical trial requirements, in response to public demand for new medicines and in an effort to ease shortages.
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