On September 24, 2018, FDA issued draft guidance on good review management principles and practices (GRMPs) for NDAs and BLAs that remains open for a 90-day comment period. The GRMPs are guidelines for the drug review process that exist to provide prompt patient access to life-saving therapies. The draft guidance describes the fundamental values and operational principles that comprise the GMRPs as well as defines the relationship between applicants and review staff during the review process.
The draft guidance identifies these three fundamental values to ensure the highest quality applications and review processes:
- Accountability is a shared fundamental value that the applicant and the review staff owe to the American public. Applicants are required to submit complete, high quality applications, while review staff are responsible for effective and efficient review management using the GRMPs. Additionally, FDA is establishing more comprehensive metrics to evaluate regulatory decisions, rather than just meeting targeted goal dates.
- Communication between the applicant and the review must be clear, complete, and concise. This allows for a transparent review process where both parties understand the reasoning behind regulatory action.
- Consistency requires that both applicants and review staff always utilize GRMPs to have the best chance of success during the review process. With that said, FDA realizes that flexibility is necessary, and deviation may be justified in individual circumstances.
Operational principles are the five elements of a thorough yet efficient review process:
- A well-designed and executed product development plan is the responsibility of the applicant. An application that is incomplete or unreadable can lead to delays in the review process. Applicants are encouraged to seek FDA feedback about product development to identify potential review issues before submission of the application. Applicants should familiarize themselves with the relevant regulatory approaches and give review teams early notice of anticipated applications so that the review team can plan accordingly.
- Review management planning charges the review team with identifying important areas of the application and potential safety issues in order to develop an efficient review timeline. The review team should promptly notify the applicant of any changes in the review timeline.
- Review team collaboration confirms that issues spanning multiple disciplines are shared within the review team and are analyzed comprehensively. An effective review team promotes rigorous review via interdependence of its members.
- Effective communication between the review team and applicant involves applicant representatives working with the review division regulatory project manager to open lines of communication. The draft guidance notes that communication should be limited to questions about application content, requests for additional information, identified review deficiencies that need correction, and preliminary comments on label drafting. FDA should not provide information about proposed regulatory action until issuance of the official written action, and applicants should not seek this information.
- Clear and concise documentation of the scientific review and regulatory decision creates the official record of FDA’s decision, as wells as documents the underlying scientific evaluation of an application. Applicants are discouraged from withdrawing an application before FDA can issue a regulatory action.
These fundamental values and operational procedures make up the GMRPs that applicants and review staff should follow to provide patients timely access to new drugs and biological products.