On October 21, 2020, China’s Center for Drug Evaluation (CDE) released “Technical Requirements for Quality and Efficacy Consistency Evaluation of Generic Chemical Injections.” In order to guide the research and development of chemical drug injections in China.

The guidance expands on the following topics:

  1. Reference Listed Drug
  2. Technical Requirements for Formulation

  3. Technical Requirements for Quality Control of APIs, Excipients and Packaging Materials
  4. Technical Requirements for Quality Study and Control
  5. Technical Requirements for Stability Studies
  6. Basic Considerations for Consistency Evaluation of Special Injections

  7. Basic Considerations for Strength-modified (Including different drug substance concentrations) Injections

  8.  Drafting of Package Insert

  9. Specification of Drug Products
  10.  Injections Requiring No Consistency Evaluation

Reference Listed Drug (RDL)

The applicant must select the reference listed drug (RLD) using Procedures for Selection and Determination of Generic Chemical Reference Listed Drugs issued by the National Medical Products Administration (NMPA) and carry out the consistency evaluation research with reference to the technical requirements specified in this document as well as relevant technical guidelines in China and abroad.

Technical Requirements for Formulation

The type and amount of excipients contained in the injection shall generally be the same as the reference listed drug (RLD). The amount in the generic drug is 95%-105% the amount of corresponding excipients contained in the RLD.

If Special solvent(s) are contained, they shall be consistent with that (those) of the RLD in terms of formulation.

Injections That do not need Consistency Evaluation

Injections such as sodium chloride injection, glucose injection, glucose and sodium chloride injection, water for injection and some radioactive drugs (such as technetium [99mTc]) are not required to undergo consistency evaluation, but are still subject to quality improvement research.

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