“Through a rigorous scientific and regulatory process, CDER’s Office of Generic Drugs (OGD) helps to ensure Americans have access to safe, effective, and high-quality generic drugs. The role of the Global Generic Drug Affairs Program is to lead, coordinate, and manage OGD’s international activities in collaboration with other offices in CDER offices and throughout the FDA to advance the overall mission of OGD and FDA. In an increasingly globalized pharmaceutical market, collaboration among drug regulators is critical. Actions one country or territory takes can affect others.

The Global Generic Drug Affairs Program has been exploring what administrative, scientific, and technical avenues FDA can take for further harmonization of generic drug standards globally by engaging with international standard-setting organizations, and through dialogue with the world’s leading regulatory authorities.

As one important example, in June 2021, OGD established a multi-country forum, the Generic Drug Cluster, to achieve a common understanding of each member agency’s generic drug regulatory requirements and to help increase scientific alignment. Regulatory requirements and scientific approaches to developing and assessing generic drugs can vary from country to country, which can add complexity to the development and approval process for generic drug developers.

The CDER conversation below reflects on the first-year progress of the Generic Drug Cluster with OGD’s Sarah Ibrahim PhD., associate director for Global Generic Drug Affairs.”1

You can read the full interview with Sarah Ibrahim here.

References

  1. Center for Drug Evaluation and Research. (2022, September 21). CDER Conversation: OGD Global Affairs Program, One Year Progress Report of Generic Drug Cluster. U.S. Food And Drug Administration. Retrieved October 19, 2022, from https://www.fda.gov/drugs/news-events-human-drugs/cder-conversation-ogd-global-affairs-program-one-year-progress-report-generic-drug-cluster

Disclaimers

  • The material in these reviews is from various public open access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
  • No official support by any organization(s) has been provided or should be inferred