Impact of new registration reform on chemical drugs R&D / 药物评价研究

ABSTRACT

The China Food and Drug Administration (CFDA) modulated the Drug Registration Regulation at 2016.In this article,the registration classification of chemical drug was analyzed,and the definition,cormotation and technical standard of new drugs and generic drugs were compared.Compared with the 2007 version of regulations,obvious changes have happened,the scope of new drugs has been narrowed,and the definition is more strict and accurate,the scope of generic drugs has been expanded.The new regulation keeps the same evaluation standards with the ICH,FDA and EMA.Regulatory changes have a profound impact on the medical research and development:promoting the reformulation of domestic pharmaceutical market,encouraging R&D and innovation in enterprises and accelerating the pace towards the international market.