Consistency Evaluation Services
Passing the generic drug consistency evaluation or being listed in the Chinese Approved Drug Products Directory is an essential requirement for companies to participate in tender and centralized procurement. If a generic drug becomes the "first" or "among the top three" to pass the evaluation, it brings significant market and economic benefits. Otherwise, there is a high risk of losing market share or even the drug approval.
Currently, consistency evaluation for oral solid dosage forms of chemical drugs has been carried out for many years, while evaluation for injections has become routine, with relevant review requirements and principles largely established.
Generic drug consistency evaluation is a comprehensive process involving a long chain and high costs. This is especially true for products approved in the early years, where the R&D and registration dossiers were often less robust. For such products, it is advisable to firstly conduct a preliminary assessment of product quality before moving on to systematic, in-depth studies. An increasing number of successful cases show that the core of generic drug evaluation lies in the pharmaceutical part, which is also the key focus of the national evaluation of generic drug quality. CMC (Chemistry, Manufacturing, and Controls) is the top priority and must be addressed firstly. Experience has shown that taking proactive, independent action is the best way to adapt to the ongoing transformation of industry.
With our extensive experience in pharmaceutical research, Kangchuanji has helped many domestic companies successfully complete generic drug consistency evaluations, enabling them to gain a competitive edge in the industry transformation.Welcome companies interested in cooperation to contact us.
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