New FDA Draft Guidance Helps Sponsors Revise or Develop New USP Monographs
Posted 10 July 2019 | By
The US Food and Drug Administration (FDA) on Wednesday published draft guidance on the US Pharmacopoeial Convention Pending Monograph Process (USP-PMP), outlining how sponsors can revise or create new monographs so they are harmonized with a new product’s FDA-approved quality and labeling requirements.
New and generic drug applicants and drug master file holders must ensure that a drug product or substance complies with applicable standards in the USP National Formulary (USP-NF).
As part of its review of applications, FDA compares the official USP-NF monograph quality standards with the quality attributes found in an application. If the submitted information is not in compliance with official compendial standards, applicants and/or drug master file (MF) holders must provide justification to FDA and work with USP to revise the monograph.
But prior to the establishment of the USP-PMP, applicants could not request changes to compendial standards (or propose a new monograph) until an application was approved by FDA. There were also delays, for six months or more, between when a monograph was revised and when it became official, FDA said.
But under the USP-PMP, which the draft guidance seeks to further explain, MF holders and applicants that have successfully filed a new drug application (NDA), abbreviated new drug application (ANDA), new animal drug application (NADA) or abbreviated new animal drug application (ANADA) with FDA and are awaiting review and approval can propose revisions to an existing monograph or can propose the publication of a new monograph.
And immediately following FDA approval of a specific NDA, ANDA, NADA or ANADA, USP will make available a revised monograph (or the new monograph) harmonized with the application’s approved specifications.
The eight-page draft features sections on how to initiate the USP-PMP (contact USP directly and inform USP of any modifications to the application) or label the product with differences to the official compendial standards, including specific recommendations for applicants and with an annex of 11 specific questions and answers.
“To avoid potential delays, USP-PMP proposals should be initiated very early in the application evaluation process. We recommend that those who intend to initiate the USP-PMP begin working on a proposal concurrent with an application’s submission to FDA. The applicant’s intention to initiate the USP-PMP should be stated in the cover letter of the application and should also be prominently displayed in all applicable section(s),” FDA says.
Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process: Draft Guidance for Industry