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FDA In Brief: FDA Finalizes Guidance with Internationally Harmonized Recommendations to Further Support Safe, High-Quality Human Drug Products

For Immediate Release:

The following quote is attributed to Michael Kopcha Ph.D., R.Ph., director of the FDA’s Office of Pharmaceutical Quality

“The FDA is continually working to promote drug innovation and improvement, strengthen quality assurance, safety and supply of drug products and enable more efficient use of industry and regulatory resources. Through the harmonization of requirements for drug lifecycle management, manufacturers and the FDA can meet these goals in less time through effective management of postapproval changes. To help provide a more predictable and efficient approach to management of postapproval changes, today we’re announcing a final guidance for industry with new International Council for Harmonisation (ICH) guidelines.


Effective implementation of this guidance will provide an opportunity for the FDA to focus attention and resources on higher risk postapproval changes, incentivizing manufacturers with additional flexibilities to continually improve their manufacturing processes, which can reduce the likelihood of quality-related supply disruptions and related drug shortages.


This guidance reflects just one element in the FDA’s work with regulatory authorities and industry associations from around the world to promote international harmonization of regulatory requirements under the ICH. The FDA is committed to continue seeking scientifically-based harmonized technical procedures for the development and manufacture of drugs.”

Additional Information

  • Today, the U.S. Food and Drug Administration is announcing the availability of a final guidance for industry, “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.” This guidance, which was adopted as an ICH Guideline in November 2019, provides a framework to facilitate the management of postapproval chemistry, manufacturing and controls changes in a more predictable and efficient manner. The guidance discusses how to identify the elements in an application that are considered necessary to assure product quality and therefore would require a regulatory submission if changed postapproval.
  • In addition to postapproval changes, the guidance has the potential to help facilitate innovations in manufacturing through a flexible, risk-based approach to regulatory oversight. Encouraging continual product improvement can help reduce product variability and prevent and mitigate shortages related to manufacturing and quality issues. In addition to benefitting industry and regulators, the approach discussed in the guidance will help to assure that patients have access to high quality therapies.
  • The FDA publishes ICH guidelines as FDA guidances. This guidance is applicable to pharmaceutical drug substances and products (both chemical and biological) that require a marketing authorization and to drug-device and biological product-device combination products that fall under the jurisdiction of the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research. Changes needed to comply with new or revised pharmacopoeial monographs are not within the scope of this guidance.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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