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China's new biosimilars guideline: more flexibility, but stricter in parts

 
• By Wang Fangqing

Three months after publishing its draft guideline on biosimilars, China's Food and Drug Administration (CFDA) has just released the final official version, although it is still described as a pilot scheme. The new guideline may look similar to the draft on the surface, but a closer comparison reveals many differences.

Three months after publishing its draft guideline on biosimilars, China's Food and Drug Administration (CFDA) has just released the final official version, although it is still described as a pilot scheme. The new guideline may look similar to the draft on the surface, but a closer comparison reveals many differences.

The draft, released in November for public consultation (scripintelligence.com, 5 November 2014), was regarded as broadly similar to guidelines published by the EU, the US the World Health Organization....

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