China Issues Three Technical Guidelines for Consistency Evaluation of Generic Chemical Injections

On 15 May 2020, the Drug Evaluation Centre of China (CDE) has issued guidelines used to evaluate the consistency of efficacy and quality of generic chemical injections.

One of the guidelines included in the “Technical Requirements for Consistency Evaluation of Quality and Efficacy for Generic Chemical Injections”.
The instructions listed serve as a guide for applicants to carry out an evaluation of the generics injections. Among the scope that it covers include products that can be exempted from consistency evaluation, requirements for reference preparation, quality control of API/excipients, prescription, and manufacturing techniques, research and control on quality, packaging materials and containers, stability studies, considerations for consistency evaluation of special injections, considerations for injections with specification changes, pharmaceutical standards and issuance of package inserts.

The second guideline, “Consistency Evaluation of Quality and Efficacy for Generic Chemical Injections: Requirements for Application Dossiers”,  informs the applicants on the types of documents that are required for submission for the evaluation of the efficacy and quality of the generic chemical injection. The required information concerns non-clinical trial data, clinical trial data, general presentation, and pharmaceutical research data.

The final guideline, “Technical Requirements for Consistency Evaluation of Quality and Efficacy for Generic Chemical Injections (Special Injections)” is tailored for chemical injections of special characteristics. As compared to the common injections, production techniques and prescription impose a higher influence on the quality and APIs’s in-vivo behavior. The required information concerns clinical study, non-clinical study, general considerations, and pharmaceutical research.

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