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Quality Consistency Evaluation for Generic Drugs

As part of the 12th Five-Year Plan for Drug Safety, the Work Plan for Quality Consistency Evaluation for Generic Drugs, issued on November 22, 2012, had clearly put forward enhancing the overall quality standards of generic drugs and launching the generic drugs consistency evaluation. The Quality Consistency Evaluation will focus on consistency of composition and clinical efficacy between the test and reference products. 

 

The evaluation results and verification testing results will be forwarded to the Chinese FDA (CFDA) for an expert panel review. Failure to obtain a satisfactory opinion from the expert panel will subject the test products to be withdrawn from the market.

 

Quality consistency can be established based on conformity with quality specifications set by the reference products and in-vitro in-vivo correlation. 

 

PHDS is sophisticated in:

1.        The test of dissolution rate in vitro

a)        Similarity comparison of the dissolution curve

b)        Assessment criteria of dissolution curve similarity

c)        Measurement of solubility-pH profiles

 

2.        Quality study of originator and reference product  

a)        comparison of process prescription

b)        comparison of impurity profile

c)        comparison of all indicators of stability

 

3.        Clinical Comparative Study