FDA finalizes guidance on drug quality consensus standards recognition program

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday published a final guidance on its process for recognizing voluntary consensus standards (VCS) related to pharmaceutical quality with an aim to promote innovation in pharmaceutical development and manufacturing.

This program applies to the gamut of CDER-regulated products, including brand drugs, generics, biologics, biosimilars and over-the-counter (OTC) medicines. FDA added that the program “will help create efficiencies in generic and biosimilar manufacturing which is an important part of streamlining generic and biosimilar development and spurring competition as part of our Drug Competition Action Plan (DCAP) and Biosimilars Action Plan.”

The guidance describes CDER’s plans to publish a comprehensive listing of recognized voluntary consensus standards related to pharmaceutical quality and describes CDER’s policies and procedures for recognizing such standards.

The goal of the program, according to CDER, is to “promote innovation in pharmaceutical development and manufacturing and streamline the preparation and assessment of marketing applications.”

Pallavi Nithyanandan, director of the Compendial Operations and Standards Staff in CDER’s Office of Pharmaceutical Quality (OPQ), said in a recent interview that the program aims to speed up the assessment of marketing applications. She said that when a standard is currently referenced in an application, a CDER assessor must determine whether that standard is acceptable and scientifically sound and aligned with FDA policies.

“We are establishing this program to recognize voluntary consensus standards, in part, to remove this burden from the assessor so that they will only need to consider whether the applicant has used a recognized standard appropriately.”

Nithyanandan said use of a recognized standard remains strictly voluntary. “This program does not apply to regulatory requirements, such as certain provisions of the Federal Food, Drug, and Cosmetic Act relating to the United States Pharmacopeia.” The program does not include electronic data exchange standards.

CDER has used consensus standards in other areas, including ones related to performance characteristics of dosage forms, testing methodologies and manufacturing practices.

FDA’s guidance, which finalizes a draft released in February 2019, adds a “clarification of the program’s policies and procedures and the program’s relationship to existing guidances, regulations, and policies under which CDER operates.” (RELATED: CDER Proposes Program to Crete Voluntary Pharmaceutical Quality Standards, Regulatory Focus 13 February 2019)

Some of the changes include a new section on requesting recognition in submissions and communicating with requestors. For example, the final version details how staff and stakeholders can submit a recognition request electronically through the CDER Direct nextGen Collaboration portal.

Also included is a new section on how CDER’s Pharmaceutical Quality Standards Working Group (PQSWG) will update the CDER’s standards database.

The guidance adds new questions and answers on the following topics:

How CDER will communicate with the standards development organizations (SDOs) regarding recognition requests;
Where recognized standards will be posted;
CDER’s expectations when a recognized standard is referenced in a marketing application;
CDER’s expectations when a recognized standard is referenced for drug products that are legally marketed without an approved application; and
How CDER’s standards recognition program will affect the other centers.

In earlier comments, industry experts urged FDA to align its approaches for standards recognition across CDER, CDRH and CBER. (RELATED: Experts Seek Alignment of Standards Recognition Across FDA’s CDER, CBER, CDRH, Regulatory Focus 19 April 2019)

Final guidance, Federal Register notice

FDA finalizes guidance on drug quality consensus standards recognition program

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