US, Canada Continue to Push for Regulatory Harmonization in the Life Sciences

Posted 02 September 2014 By Alexander Gaffney, RAC

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US and Canadian regulators are continuing to work together to harmonize the way in which they regulate pharmaceuticals, biologics, over-the-counter drugs, medical devices and veterinary products, both governments confirmed in an update this week.

Background

Both governments' efforts come from a 2012 regulatory initiative known as the Regulatory Cooperation Council (RCC), whose stated goal is to increase regulatory cooperation between both countries. That cooperation, it is hoped, will eliminate economic barriers to doing business in either country.

And for the life science industry, increased cooperation means fewer regulatory barriers as well. In a July 2012 statement, the US and Canada announced that the US Food and Drug Administration (FDA) and Health Canada (HC) would be working to "better align our regulatory systems, reduce unnecessary duplications and differences and ... better leverage resources."

That effort, both regulators said, would involve a "systemic alignment of regulatory systems, strategies and practices," all in the hopes of eliminating needless red tape.

As Regulatory Focus reported at the time, the effort was to focus on the creation of a harmonized electronic submissions gateway (ESG), a harmonized monograph system for OTC drugs, a mutual reliance on GMP inspections and simultaneous review of veterinary drugs.

Since that announcement, Focus has reported on the progress of several of those initiatives, including the ESG, the simultaneous veterinary review process and the challenges of relying upon other regulators for inspections.

Budding Harmonization

But to date, several aspects of the regulatory harmonization plan have been either kept under wraps, or haven't been subject to much attention since the launch of the program.

In a 29 August 2014 update on the program, Office of Information and Regulatory Affairs (OIRA) Administrator Howard Shelanski said existing efforts would continue to move forward and several new ones were created under the newly announced Joint Forward Plan.

Shelanski said the plan "will remove duplicative requirements, develop common standards, and identify potential areas where future regulation may unnecessarily differ."

"Regulatory cooperation has to mean more than just 'aligning' specific rules across the border," Shelanki continued. "Such a rule-by-rule approach is neither practical nor scalable enough to meet our ever-changing regulatory environments. We need to think more broadly and creatively on how to build cooperative frameworks to achieve our economic and regulatory policy goals in a more dynamic manner."

Efforts New and Old

Under the plan, FDA and Health Canada will continue to work on the electronic submission gateway for pharmaceuticals and biologics, expanding it "where appropriate."

In addition, the plan calls for both regulators to "harmonize and align their pre and post-marketing surveillance requirements and standards (including pharmacovigilance issues) through the work of the International Conference on Harmonisation (ICH), the International Pharmaceutical Regulators Forum (IPRF) and the International Coalition of Medicines Regulatory Authorities (ICDRA)." The Pharmaceutical Inspection Co-operation Scheme (PICS) will also be used, according to the report.

On the medical device front, the report notes FDA's and Health Canada's involvement in the International Medical Device Regulators Forum (IMDRF), which is the regulators-only successor group to the Global Harmonization Task Force (GHTF), which disbanded in 2012. Other "pre and post market regulatory convergence topics" may also be worked on separate from IMDRF, the report notes.

The report also notes that the veterinary joint review and OTC monograph harmonization plans are set to continue and expand.

The report makes no mention of the joint inspection plan discussed in 2012.

 

RCC Report

Shelanski Statement

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Categories: Biologics and biotechnology, Prescription drugs, Over the counter drugs, In vitro diagnostics, Medical Devices, Veterinary products, Postmarket surveillance, Submission and registration, News, US, Canada, CBER, CDER, CDRH, Health Canada, ICH, IMDRF

Tags: RCC, Regulatory Harmonization, ICH, PICS, ICDRA, IPRF

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