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Regulators in US, EU, Japan Move Toward Common PGx Approaches

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Two recent complementary agreements between international regulatory agencies — a nascent effort by the International Conference on Harmonization and a joint genomic data-submission document produced by the US Food and Drug Administration and the European Medicines Agency — may help to establish a common pharmacogenomic language for regulators and drug makers.

The initiatives are not directly linked, but they represent an effort by international regulators to agree on common views of data for pharmacogenomics, and could lead to regulatory processes in Japan, the United States, and Europe that reduce duplication of effort.

Last week during a steering committee meeting for the International Conference on Harmonization, representatives from US, European, and Japanese regulatory agencies and industry organizations met for the first time to discuss pharmacogenomics, with the goal of eventually incorporating uniform pharmacogenomics terminology into drug discovery and development protocols.

The ICH pharmacogenomics initiative, which is still in its infancy, could lead to common genomic, proteomic, and other procedures and required data from drug makers, and could reduce the amount of effort companies need to devote to regulatory submissions that include pharmacogenomic components.


The FDA's and the EMEA's approach to developing joint pharmacogenomic data-submission "guiding principles" could provide a roadmap for how the ICH might approach standardizing pharmacogenomics terms.

The steering committee meeting coincided with the release of a "guiding principles" document by US and European regulatory agencies describing how drug and diagnostic companies can discuss their pharmacogenomic data with both bodies simultaneously. Through these methods, the US FDA and the EMEA hope to streamline regulatory procedures for pharmacogenomics on both sides of the Atlantic.

The ICH

An ICH steering committee working group made up of representatives from the regulators and industry in its three constituent regions met last week in Yokohama, Japan, to focus on establishing "consistent" pharmacogenomics terminology. Its goal is to encourage drug makers to use that terminology in documents when applying for regulatory approval in the US, Europe, and Japan, and to encourage drug makers to integrate pharmacogenomics into therapeutic development.

The ICH, based in Geneva, was established in 1990 to develop standard means for regulators and pharmaceutical companies based in the United States, Europe, and Japan to test and represent data on drug quality, safety, and efficacy, so that drug makers would not have to duplicate efforts in order to register their products or apply for approval with regulators in the three member regions. The ICH has no regulatory or oversight power; rather, it is a forum in which the interested parties meet to establish common standards — regulators use its standards to ensure consistency between agencies.

For example, US, European, and Japanese regulators and industry organizations agree on ICH-originated "harmonized" guidance documents for such things as genotoxicity safety studies. Each of the regulatory agencies then publishes the guidances in their own countries or regions.

From the United States, representatives from the FDA — including Felix Frueh, head of the FDA Interdisciplinary Pharmacogenomics Review Group — and the Pharmaceutical Research and Manufacturers of America attended the recent meeting. European delegates included officials from EMEA and the European Federation of Pharmaceutical Industries, while Japan's Ministry of Health, Labor and Welfare, and the Japan Pharmaceutical Manufacturers Association sent representatives as well.

FDA-EMEA Joint Submissions

According to Allen Rudman, associate director of the Office of Clinical Pharmacology and Biopharmaceutics in the FDA's Center for Drug Evaluation and Safety, the FDA and EMEA's approach to developing joint pharmacogenomic data-submission "guiding principles" could help the ICH to begin thinking about how to standardize pharmacogenomics terms.

The FDA and EMEA document is called "Guiding Principles: Processing Joint FDA EMEA Voluntary Genomic Data Submissions within the Framework of the Confidentiality Agreement," Under the framework, drug or diagnostics companies that submit genomic data under the joint program will meet with both the FDA's Interdisciplinary Pharmacogenomics Review Group and EMEA's Pharmacogenomics Working Party, with one of the agencies attending via video conference.

The document contains a list of definitions agreed to by the agencies, along with a flowchart describing how voluntary pharmacogenomic submissions would be processed.

"We go through the issues with [the sponsor] and we present our views," Rudman told Pharmacogenomics Reporter. "They gain a lot of feedback all at one time on a lot of different issues from perspectives on both sides of the Atlantic."

The next FDA policy step may be a guidance document, but the agency has no distinct plans at the moment. "We're going to continue on with the program as it is — we keep getting voluntary submissions," Rudman said. "The idea is to move this forward, and at some point I think we're going to bring it out as guidance, but we don't have an idea when, yet. The policies will really promote the use of pharmacogenomics."

A likely next guidance will be for drug-diagnostic companion products, based on the concept paper that the FDA issued last April, Rudman said.

The FDA and the EMEA have issued guidances on pharmacogenomic data submissions and briefing meetings in the past. When the FDA published guidelines on voluntary submissions in 2004, the agency informally met with the EMEA to help the agencies synchronize their pharmacogenomic goals and strategies.

Representatives from the FDA and the ICH were not available for comment on the steering committee meeting before deadline.

— Chris Womack ([email protected])

 

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