Beijing has announced new rules that will help speed up approvals of medicine and ease bottlenecks when introducing new treatments.

For decades, Chinese patients have struggled to gain access to the latest medicines due to bureaucratic delays that have delayed drug development, reports Bloomberg. Under the new rules, data from overseas clinical trials can be used for drug registrations in the country. That removes the need for manufacturers to conduct added tests in China after receiving overseas approvals and will likely cut delays in the launch of new drugs by several years.

It is worth mentioning that this is a fundamental growth opportunity for international and local drug makers in the world’s second biggest pharmaceutical market. Faster approvals could see a revenue boost to Pfizer Inc., AstraZeneca Plc, GlaxoSmithKline Plc and other multinationals that are expanding to those areas.

Jialin Zhang, senior health-care analyst at ICBC International Research Ltd, said, “For multinational and leading innovative drug makers, the anticipated acceleration of approval will improve patient’ access to new medicine and increase revenues for pharmaceutical companies.”

Pfizer and AstraZeneca welcome the new rules. In a statement, Pfizer, said, the policies will “pave the way for China’s integration into the system for multiregional clinical trials that supports global drug development.”

Followed by AstraZeneca, who stated, “China is a key growth market for AstraZeneca and we are working closely with authorities to ensure our medicines are accessible by the many patients who can benefit from them.”

Moreover, the recently announced reforms include other measures to speed up approvals for clinically needed drugs and equipment, establish a compulsory-licensing system and make it easier for research institutions to conduct clinical trials, according to the document.

The government has revealed that they will be exploring a new system linking drug approvals to patent status. As a result, it could potentially delay the introduction of generics when there are legal challenges posed by the patent holder.

Wu Zhen, vice minister of China’s FDA, commented on China’s protection of intellectual properties which is still lacking, “and this is also an important reason that restricts the development of our medical innovation industry.”

He continued to explain how measures on patents were previously adopted by drug developed markets, including the USA, Europe and Japan, and their implementation helped boost innovative companies, as well as generic drug makers.  


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