Good Review Management Principles & Practices, Part One: Fundamental Values
On Tuesday, September 25th, the FDA published a draft guidance containing recommendations on good review management principles and practices (GRMPs) for new drug applications (NDAs), Biologics license applications (BLAs), or efficacy supplements/supplements with clinical data. The document, entitled “Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications,” applies to human drug applications and biosimilar biological product applications.
In issuing this draft guidance, the FDA’s goal is to “ensure that the review process is managed in a consistent and efficient manner, thereby decreasing the number of review cycles necessary for approval and enhancing patients’ timely access to important therapies. This guidance also clarifies the roles and responsibilities of review staff in managing the review process and identifies ways in which applicants may support an efficient and robust review process.”
GRMPs were originally established under PDUFA III in 2002, and in April 2005, the Agency published a guidance document entitled “Good Review Management Principles and Practices for PDUFA Products.” When finalized, this week’s draft guidance will replace the original document. Significant changes in the updated document include:
- “Advances in the Prescription Drug User Fee Act (PDUFA) program and the implementation of the Biosimilar User Fee Act (BsUFA)
- Evolution of GRMPs to support additional regulatory programs such as breakthrough therapy, the Program for Enhanced Review Transparency and Communication for NME (New Molecular Entity) NDAs and Original 351(a) and 351(k) BLAs (the Program), and risk evaluation and mitigation strategies (REMS)
- A consolidated focus on the fundamental values and operational principles that serve as the foundation for the GRMPs”
Since the publication of the 2005 guidance document, the Agency’s implementation of these principles has been updated periodically “to reflect the ongoing evolution of statutory and regulatory requirements as well as innovations that become part of FDA’s review process for marketing applications.” Despite the changes that have been made over the years, the fundamental values behind the GRMPs have remained constant.
In its recent draft guidance, FDA notes that it “seeks the highest levels of quality in submitted applications, Agency reviews and processes, and final regulatory decisions.” Furthermore, the Agency states that quality can be achieved by applying a number of fundamental values. As such, successful implementation of the GRMPs is dependent on the FDA’s adherence to these values in order to ensure that it is making high-quality regulatory decisions in a consistent and timely manner.
The following fundamental values serve as the foundation for the GRMPs:
“FDA is accountable to the American public for helping to ensure the safety, efficacy, and quality of new drug and biological products,” and for maintaining a high-quality review process that produces informed decisions in an efficient and timely manner. In addition, review staff are also accountable for the implementation of the GRMPs and the associated policies and processes. Sponsors are responsible for submitting high quality and complete applications and making optimal use of the product development resources that are available.
Transparency and clarity are key components of an application’s review and achieving them requires clear, complete, and concise communication. Transparency ensures that applicants understand FDA’s regulations, are informed of review progress, and that both sponsors and review staff are able to anticipate and respond to potential issues and plan for next steps. Clarity allows FDA to understand the applicant’s assessment of the product’s benefits and risks and ensures that the applicant understands the reasoning behind FDA’s given regulatory action.
“Consistent application and support of the GRMPs by review staff and applicants are critical to the overall success of the marketing application review process.” However, flexibility is possible if/when a thorough evaluation of an individual situation justifies doing so.
Stay tuned for information on the operational principles outlined in FDA’s draft guidance on GRMP’s – part two is coming soon!