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Since 2015, my country has initiated the process of in-depth reform of the drug review and approval system. “Improving the quality of generic drugs and accelerating the quality consistency evaluation of generic drugs” has become one of the five major goals of the reform. Before the end of 2018, the completion of the quality consistencyRead more

Medicilon has successfully completed a number of quality consistency evaluation cases in the quality consistency evaluation of generic drugs. It has rich experience in the development of generic drugs and can provide you with more professional consistency evaluation services. The “Conformity Evaluation of Generic Drugs” is mainly for the re-evaluation of the quality of theRead more

Heganding comes in 100-mg tablets. It’s a treatment for chronic Heptitis B adult patients with ALT rising, active virus replicating and liver decompensation. During the evaluation project, Medicilon’s CMC and management team utilized innovative technology and comprehensive understanding of related guidance and regulations to contribute to success of the consisteny evaluation with biowaiver.Read more

Eight years have passed since the evaluation of the consistency of generic drugs has been carried out. The excitement, wait-and-see, loss, and rational confrontation periods of the industry have all passed away. Rethinking the issue of consistency evaluation of generic drugs requires us to think from the top-level design of the pharmaceutical industry. We lookRead more

Oseltamivir phosphate is a kind of specific influenza virus neuraminidase inhibitor, and it is an effective way to treat influenza virus clinically. Recently, a Chinese pharmaceutical company’s oseltamivir phosphate capsule (75mg) passed the consistency evaluation for the first time, which enabled it to gain advantages in future market expansion and medical insurance payment. The supplementaryRead more

Consistency evaluation is a major favorable policy for the overall improvement of the pharmaceutical industry. The key aspects of general R&D implementation include “reference preparations-secondary development of prescription processes (pharmaceutical research)-BE filing-BE testing-on-site assessment-review by drug control institutes-consistent Application for sexual evaluation-CFDA approval”. At present, it takes about 20-28 months to complete the entire processRead more

The authoritative interpretation of 18 key issues in the consistency evaluation of generic drugs is here! On August 25, the State Food and Drug Administration issued an announcement on issues related to the consistency evaluation of the quality and efficacy of generic drugs, further clarifying the selection and use of reference preparations, the conduct ofRead more

The consistency evaluation started in January 2012 “Notice on Printing and Distributing the National Drug Safety’Twelfth Five-Year Plan’ (Guo Fa [2012] No. 5, hereinafter referred to as the “Notice”)” and “National Food and Drug Supervision” in February 2013. Notice of the Administration on Carrying out the Quality Consistency Evaluation of Generic Drugs“, since then, consistencyRead more