On June 25, NMPA announced the 42nd batch of reference preparations catalogue, a total of 77 reference preparations, 10 of which are supplements. Up to now, a total of 4508 reference preparations in all 42 batches of catalogues have been released.

The reference preparations that have not passed the review have 220 specifications, of which 112 are injections

The main reasons for not passing the review are:

1. The specification is unreasonable, and it is less than the minimum dose recommended in the instructions for a single use;

2. The original imported product of this product has been released as a reference preparation, and the reference preparation applied by the enterprise is consistent with the published reference preparation concentration;

3. This product is different from the domestic marketed varieties in the loading volume, and the domestic approved usage and dosage are different, and the administration is limited;

4. This product has no reference preparation status;

5. Failure to provide complete and sufficient safety and effectiveness data;

6. There are certain defects in related substances.

7. Other domestic drugs with more sufficient safety and effectiveness data have been published as reference preparations.