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  1. From a Global Perspective

FDA’s Efforts to Achieve Global Regulatory Harmonization of Generic Drug Programs


By Sarah Ibrahim, Ph.D.

March 28, 2022

From a Global Perspective


Generic drugs play an important role in helping to address rising health care costs and in promoting access to medicines across the world. Regulatory requirements and scientific approaches can vary from country to country. For example, it’s common for countries to require different manufacturing specifications and different tests to support approval.

Faced with these challenges, manufacturers tend to be selective about the markets in which they choose to compete. This may lead to reduced market access and competition or limited sources of drugs in certain markets, including those in smaller and less developed countries. 

The FDA has been exploring what administrative, scientific, and technical avenues we can take to further harmonization of generic drug standards globally, by employing international standard setting organizations and through dialogue with the world’s leading regulatory authorities.

World map made of pills

The International Council for Harmonization (ICH) is considered the global venue for harmonization of standards for pharmaceutical drugs. ICH historically focused on developing international standards for new drugs. In 2018, at the FDA’s urging, ICH adopted a proposal for developing scientific and technical standards for generic drugs and called for a working group on the topic, which the CDER Office of Generic Drugs global affairs team now leads. One of the first workstreams in the ICH proposal was the development of a guideline on standards for demonstrating equivalence for immediate-release oral dosage forms of drugs. 

With variations in the regulatory approaches around the globe, harmonization can be better achieved through greater understanding of our counterparts’ approaches. That’s why we created the Generic Drug Cluster in June of 2021. The cluster offers a forum for the world’s leading regulatory agencies to achieve a common understanding of each agency’s regulatory requirements for approval as well as their current thinking on topics related to generic drug development. 

We see this forum as providing an opportunity to discuss policies under development, including draft guidances for industry, and the scientific basis for decisions on those policies; to discuss specific targeted issues and product/class-related scientific review issues; to seek alignment in our scientific evaluation of products; and to address long-term safety issues to ensure a global safety net for generic drugs through confidential sharing of reports. The knowledge exchange allows us to bridge our scientific recommendations as we are developing them, prospectively harmonizing our scientific thinking.

So far, complex generics have been our primary focus. These are products with complex active ingredients, formulations, delivery routes, dosage forms, or methods of administration such as those supplied in metered dose inhalers and auto injectors. The development program for these products can take longer and cost more than for simple generic drugs. Since the cluster was created last year, we have held four cluster meetings, resolved certain review issues, and identified complex generic development challenges of mutual interest and patient importance.

Sarah Ibrahim quote: "With variations in the regulatory approaches around the globe, harmonization can be better achieved through greater understanding of our counterparts’ approaches. "

We also are working toward harmonization in a Parallel Scientific Advice pilot program with the European Medicines Agency. Under this program, applicants who plan to submit an Abbreviated New Drug Application for a complex generic to the FDA and a Marketing Authorization Application for a hybrid product to the EMA can meet in real-time to receive concurrent scientific advice from both agencies. Successful collaboration may provide applicants with a deeper understanding of the basis of regulatory decisions from both agencies, optimize applicants’ global product development programs, and help applicants avoid unnecessary replication of studies or unnecessary diverse testing methodologies to satisfy both agencies, which can prolong the development of complex generic products.

The FDA is committed to making generic drugs more accessible around the world. We will continue to explore ways to further harmonize generic drug standards because we believe that all will benefit — those who make and market complex generic drugs, those who regulate them, and, most importantly, those patients who need to have access to them.

Sarah Ibrahim, Ph.D., is the Associate Director of Global Generic Drug Affairs in the FDA's Center for Drug Evaluation and Research, Office of Generic Drugs

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