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Consistency evaluation


Consistency evaluation

Consistency evaluation

Consistency evaluation

Consistency evaluation

Consistency evaluation

Consistency evaluation

      According to the requirements of the State Council document, generic drugs are required to conduct consistent evaluation of quality and efficacy. In 2016, CFDA also intensively issued many policies, regulations and guidelines on consistency evaluation, and organized multiple professional trainings and policy announcements. For many pharmaceutical companies, the consistency evaluation is like the original GMP transformation. It has to be carried out. The consistency evaluation of most chemical drug varieties includes two studies of pharmacy and bioequivalence; but some cannot be found. Reference preparations or special varieties that cannot be studied for bioequivalence also need to be tested for clinical effectiveness.

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