Stricter rules needed on drug approvals

China needs more stringent requirements for the approval of generic versions of biologics, complex drugs made from living cells, to ensure their safety and effectiveness, according to an industry report.

Generic copies of biological drugs can be registered as new products in China with fewer testing requirements than originals, according to the report, led by the R&D-based Pharmaceutical Association Committee, which represents drugmaking giants including Roche Holding AG and Pfizer Inc.