As per the Requirements, the applicant is required to conduct studies on manufacturing process, quality, and stability on the proposed generic drug without an RLD. With the studies, the applicant should prove that the proposed generic drug’s quality is no lower than those of the drugs which meet the following four conditions:
1) Having the same API with the proposed generic drug;
2) Supported by sufficient quality studies;
3) Having solid foundation for marketing authorization;
4) Accounting for a fairly large market share in the therapeutic area of the proposed generic drug.
The applicant should also assess the expected clinical value of the generic drug. It will be deemed to possess the value only when it meets all three conditions:
1) The proposed indication is clearly defined, with a well-defined dosage regimen. The drug aligns effectively with the requirements and practices of clinical diagnosis and treatment in China.
2) The proposed drug is a mainstream, widely-used therapy without alternative treatment available. Its clinical benefits outweigh risks.
3) The proposed drug has substantial data supporting its entry into clinical trials.
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