Basic technical requirements for drug injection research and development from upstream to downstream

1. Injection/local sterile preparation (eye and ear preparation)

Two of the three registered batches shall reach at least 10% of the proposed commercial production scale; Or (2) if the filling volume of each bottle/bottle is more than 2.0 mL, it is 50 L/batch; if the filling volume does not exceed 2.0 mL, it is 30 L/batch; The above (1) or (2) should choose the larger batch (after packaging).

When the applicant applies for multiple filling specifications (such as 1 mL, 2 mL and 3 mL), it is recommended that the batch size should be at least 50 L. The third batch can be less than 10% of the proposed commercial production scale, but it should reach at least 25% of the maximum batch of the registered batch (after packaging).

2. Special injection (such as liposomes, microspheres, micelles, etc.)/inhalation aerosol/inhalation powder aerosol

It is recommended that the registered batch production scale be consistent with the proposed commercial production scale. It is stipulated in the Technical Guidance on the Research and Development of Drug Injections that for special types of injections, the registered batch production scale is generally at least one fifth of the industrial production scale or at least 1000 pieces/bottle, whichever is larger. For special varieties with industrial production scale less than 1000 tubes/bottle, the registered batch production scale shall be consistent with the industrial production scale.

3. Transdermal patch

The three registered batches should reach at least 10% of the proposed commercial production scale (after packaging), or 25000 preparation units (each specification), whichever is more. For skeletal products, when different specifications are determined by the size (surface area) of the transdermal patch, it is recommended to submit the patch research data produced by three batches of skeletal layers when applying.

4. Cream/ointment/gel/suppository

For non-sterile preparations, the three registered batches should reach at least 100 kg or 10% of the proposed commercial production scale, and choose more of the two (after packaging).

5. Others

For other types of preparations not covered in this article, the registered batch production scale of generic drugs can be implemented with reference to relevant internationally accepted technical guidelines. For the following cases, the registered batch production scale of generic drugs can be lower than the above requirements: