In February 2019, CDER outlined a program via draft guidance where stakeholders can propose pharmaceutical quality standards for recognition by CDER, providing industry with additional resources for pharmaceutical development and manufacturing. Today, CDER is issuing the final guidance for this program, CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality, and launching a new portal to submit standards for potential recognition. This program is intended to promote innovation in pharmaceutical development and manufacturing.

Standards development organizations develop consensus standards following the elements of openness, balance, due and appeals processes, and consensus. Organizations following these principles while developing standards ensure that all participating stakeholders are heard. The use of consensus standards by manufacturers is voluntary, but FDA encourages manufacturers to use FDA-recognized consensus standards for their premarket submissions of drug applications. By recognizing voluntary consensus standards related to pharmaceutical quality, FDA can leverage accepted standards to support efficient drug development and oversight of drug quality. 

In this CDER Conversation, we speak with Pallavi Nithyanandan, director of the Compendial Operations and Standards Staff in the Office of Pharmaceutical Quality, about the program, how stakeholders can participate, and how the program may provide industry with additional resources for pharmaceutical development and manufacturing.

Why is CDER establishing this program?

CDER’s Quality Standards Program streamlines the assessment of marketing applications and promotes innovation in pharmaceutical development and manufacturing. Currently, when a standard is referenced in an application, a CDER assessor must spend time to determine whether that standard is acceptable, that is, whether the standard is 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.

This program will help promote innovation in pharmaceutical development and manufacturing by providing transparency regarding CDER’s thinking about new technologies or approaches that are applicable to a product type. This may help stakeholders more predictably meet regulatory expectations for CDER-regulated products and streamline product development and the preparation of an application. Once CDER has recognized a standard, applicants will generally not have to validate the approach outlined in the standard and can instead focus on appropriate use of the method and acceptance criteria.

Has CDER used voluntary consensus standards before now?

This program is not unprecedented; other Centers in FDA have similar programs and FDA has participated in the development and use of voluntary consensus standards for over 30 years. For example, FDA has relied on standards related to performance characteristics of dosage forms, testing methods, manufacturing practices, labeling, and other technical or policy criteria.

However, the CDER Quality Standards Program will be the first of its kind for pharmaceutical quality. It will provide clarity to industry and CDER staff on the use of these standards. Note that this program aligns with the National Technology Transfer and Advancement Act (NTTAA) and Office of Management and Budget (OMB) Circular A-119, which directs federal agencies to achieve greater reliance on voluntary consensus standards developed in the private sector and less reliance on standards developed by and for the government.

How does the process work, and what does it mean when CDER recognizes a standard?

Under this program, the process begins when CDER receives a candidate consensus standard, with relevant information such as the scope and purpose of the standard.

CDER will then determine whether to recognize a standard, in whole or in part, following an internal scientific and policy evaluation.

If a standard is recognized, CDER will prepare an information sheet describing the scope and extent of CDER’s recognition of that standard as well as any other relevant information.

Finally, the process ends when CDER posts the information sheet of the recognized standard in a publicly searchable database on the CDER Quality Standards Program web page.

CDER’s recognition of a voluntary consensus standard means that the agency found the standard potentially helpful to industry and CDER staff.

What is the scope of the CDER Quality Standards Program?

The program covers voluntary consensus standards related to pharmaceutical quality for CDER-regulated products, developed by standards development organizations that follow procedures which are further described in the guidance. The program considers targeted standards, such as a test method for a specific product, and standards applicable to a broad range of products and processes.  

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 standards recognized in the voluntary consensus standards program do not include electronic data exchange standards which address rules for data structure and formatting. Even if an industry stakeholder references one of CDER’s recognized voluntary standards in an application or during an inspection, FDA may still request additional information to demonstrate that the standard was followed and is fit for the intended purpose.

This program is intended for all drugs, including brand, generics, biologics, biosimilars, and over-the-counter drugs. It 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 and Biosimilars Action Plan.

How can a standard be submitted for recognition?

Those interested in submitting a standard for recognition can use the submission portal. Information on what to include in the request can be found here.

The program will notify the requestor through the portal if the request was received, whether there will be an evaluation of the standard, if additional information is needed, and of the recognition decision.