After all the hubbub of drug safety and IP protection, China took some major steps in 2007 to reform its regulatory system. In all, China has issued 53 regulations in 2007 that affect drugs, devices and food. But, according to Chen Yang, an attorney from the Beijing office of Sidley Austin, China overlooked three things on multinational pharma’s wish list: defining what constitutes a new chemical entity, assuring confidentiality of submissions for drug regulation, and linking drug approvals to patent protection.
