In the pharmaceutical industry, RLD stands for Reference Listed Drug. An RLD is the specific approved drug that a generic drug applicant (ANDA applicant) references when seeking approval to market a generic version.
Understanding the Role of RLDs in Generic Drug Approval
The RLD plays a critical role in the Abbreviated New Drug Application (ANDA) process. The ANDA pathway allows generic drug manufacturers to gain approval without repeating extensive clinical trials demonstrating safety and efficacy. Instead, the generic drug must demonstrate bioequivalence to the RLD.
Key Aspects of the RLD:
- Basis for ANDA Approval: The ANDA applicant relies on the RLD's existing approval. The ANDA demonstrates that the proposed generic drug is essentially the same as the RLD in terms of active ingredient, dosage form, strength, route of administration, and intended use.
- Demonstration of Bioequivalence: A crucial part of the ANDA is proving that the generic drug is bioequivalent to the RLD. Bioequivalence means that the generic drug delivers the same amount of the active ingredient to the site of action at the same rate as the RLD.
- Reference Standard: The RLD serves as the standard against which the generic drug's performance is compared.
RLD vs. Innovator Drug
While often used interchangeably, it's important to note the subtle difference. The "innovator drug" refers to the original, patented drug that underwent the full New Drug Application (NDA) process. The RLD is the specific version of that innovator drug listed by regulatory agencies (like the FDA in the US) that generic manufacturers must reference.
Why is the RLD Important?
The RLD system streamlines the generic drug approval process, making affordable medications available to the public more quickly. It reduces the cost of drug development because generic manufacturers don't have to repeat the costly clinical trials already performed for the RLD.
