CFDA drafts new drug review initiatives

China FDA released a draft of new drug review initiatives aimed at speeding the review process for marketing applications and reducing application backlogs. According to Sidley Austin LLP, the proposed initiatives would create a separate pathway for CFDA to review pediatric drugs and applications undergoing concurrent review in the U.S. and EU, and create more stringent requirements for generic drug applications.

The firm, which specializes in Asia-Pacific life sciences law, said CFDA's proposed initiatives would include expedited review of drugs addressing urgent clinical needs and whose patents expire soon. ...