As per the Notice, ANDA without RLD means that the applicant plans to copy a drug that is not in the RLD Catalog. For such a generic candidate, NMPA requires the applicant to fulfill the following requirements:

• Conducting chemistry, manufacturing, and controls (CMC) studies to prove the proposed generic drug’s equivalence to marketed drugs with the same active pharmaceutical ingredient (API);

• Assessing and demonstrating the proposed drug’s clinical value; and

• Submitting a communication application for having a type-III meeting with CDE.

Related:

• Technical Requirements and Application Dossier Requirements for Studies on Generic Drugs Without Reference Listed Drugs (RLDs)

• Dossier Requirements for Communication Applications for Studies on Generic Drugs Without Reference Listed Drug (RLDs)