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Generic Drug Clinical Studies

Release time:

2020-09-25 11:02

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Opinions of the General Office of the State Council on Conducting Evaluations of the Quality and Efficacy Consistency of Generic Drugs (Guobanfa [2016] No. 8) Generic drugs that were approved for marketing prior to the implementation of the new classification system for chemical drug registration—and which have not been approved in accordance with the principle of consistency in quality and efficacy with the originator drugs—must undergo consistency evaluations. The consistency evaluation of generic drugs refers to the phased and batch-wise assessment of the quality consistency of generic drugs already approved for marketing, based on the principle of consistency in quality and efficacy with the originator drugs. In other words, generic drugs must achieve a level of quality and efficacy that is consistent with the originator drugs. The purpose of conducting these consistency evaluations is to ensure that generic drugs are comparable to the originator drugs in terms of both quality and efficacy.
Generic Drug Clinical Studies
Generic Drug Clinical Studies

Pharmaceutical Research Evaluation and Recommendations;

Bioequivalence Clinical Operations;

Randomized controlled trial clinical study;

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Registration Affairs

Registration Affairs

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Early clinical development

Early clinical development

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Phase II-IV Clinical Trials

Phase II-IV Clinical Trials

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Post-Marketing Reevaluation Study

Post-Marketing Reevaluation Study

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Medical Affairs

Medical Affairs

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Quality Assurance Services

Quality Assurance Services

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Generic Drug Clinical Studies

Generic Drug Clinical Studies

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Personnel Outsourcing (FSP) Services

Personnel Outsourcing (FSP) Services

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