CFDA called for manufacturers of approved generics to perform conformity assessments of their product portfolios in a draft guidance document late last year. Now, the State Council has proposed policy measures designed to encourage companies to assess the conformity of their products. While CFDA must rely on the regulatory machinery to drive the changes, officials at the State Council intend to use their broader set of powers to establish commercial incentives for the carrying out of conformity assessments.
The State Council missive proposes making insurers and medical centers give priority to products that have undergone conformity assessments. Companies that take their drugs through the process may also be eligible for forms of financial support. The State Council proposed these fiscal measures alongside more technical proposals, which cover the choice of reference formulations for conformity assessments, the process for testing in vivo bioequivalence and the timeline for the completion of the evaluations.
By publishing the document, the State Council has provided additional details of how China’s drive to improve the quality of generic drugs sold in the country could advance over the coming years. As it stands, officials are concerned that some products came to market on the basis of flawed datasets, resulting in consumers taking generics that fail to match up to the safety, efficacy and quality of their reference innovator drugs. The attempt to weed out subpar approved products is following closely behind CFDA’s initiative to remove weak applications from its backlog of submissions.
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