Drugdu.com expert's response:

The "generic drug consistency evaluation" marked on Moxifloxacin Hydrochloride Tablets indicates that this generic drug has undergone comparative quality and efficacy trials with the original branded drug and has been proven to possess equivalent quality and efficacy.

Specific Meaning and Background

Definition and Purpose: The generic drug consistency evaluation is a systematic assessment conducted on already-marketed generic drugs. It requires that generic drugs maintain consistency with the original branded drug in terms of active ingredients, dosage forms, specifications, routes of administration, and therapeutic effects. The core objective is to ensure that generic drugs can serve as substitutes for the original branded drugs, delivering the same therapeutic effects while guaranteeing public safety and efficacy in medication use.

Policy Background: China initiated the generic drug consistency evaluation program in 2016, aiming to enhance the overall quality of generic drugs through a phased approach to quality consistency evaluation. Drugs that pass the evaluation are allowed to display relevant labels on their packaging as a visual representation of quality certification.

Practice of Consistency Evaluation for Moxifloxacin Hydrochloride Tablets

Evaluation Content: For Moxifloxacin Hydrochloride Tablets, the consistency evaluation encompasses pharmaceutical equivalence (such as compliance in active ingredients, dosage forms, and specifications) and bioequivalence (such as similarity in the drug's absorption, distribution, metabolism, and excretion processes within the human body compared to the original branded drug). Companies are required to demonstrate consistency in characteristics through pharmaceutical research and then verify the similarity of pharmacokinetic parameters in the human body through bioequivalence trials.

Companies and Products That Have Passed the Evaluation: Several companies' Moxifloxacin Hydrochloride formulations have successfully passed the consistency evaluation, including Nanjing Youke Pharmaceutical, Sichuan Kelun Pharmaceutical, and Guilin Pharmaceutical, among others. The products from these companies have undergone rigorous trials and have been proven to be comparable in quality and efficacy to the original branded drug.

Significance and Impact of Consistency Evaluation

For Patients: Generic drugs that have passed the consistency evaluation can be used as substitutes for the original branded drugs, ensuring both therapeutic efficacy and safety while reducing medication costs. For instance, generic drugs for treating hyperlipidemia are priced at only one-tenth of the original branded drugs, significantly alleviating the financial burden on patients.

For the Pharmaceutical Industry: The consistency evaluation drives companies to elevate their research and development as well as production standards, promoting industrial upgrading and structural adjustments in the pharmaceutical sector. Companies that pass the evaluation can enhance their market competitiveness, while products that fail may face restricted use or withdrawal from the market.

For Healthcare Insurance Policies: Drugs that have passed the consistency evaluation hold a competitive edge in healthcare insurance reimbursement and procurement by medical institutions, aiding in expanding market share and improving accessibility.