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NASEM Committee Calls to Expand Agreements Between Drug Regulators

Posted 21 November 2019 | By Zachary Brennan 

NASEM Committee Calls to Expand Agreements Between Drug Regulators

A committee convened by the National Academies of Sciences, Engineering, and Medicine (NASEM) on Thursday released a report outlining the ways that drug regulators currently share information globally and also offers recommendations for improving those relationships.

The report, created at the request of the US Food and Drug Administration’s (FDA) Office of Global Policy and Strategy, calls on regulatory authorities, especially those from higher income countries, to increase unredacted information sharing and transparency to reduce redundancies.

Last summer, FDA and the European Medicines Agency (EMA) fully implemented their mutual recognition agreement (MRA) to allow for the mutual reliance on good manufacturing practice (GMP) inspections of drug facilities. FDA also has a relationship related to the approval of certain oncology medicines with Australia and Canada, known as Project Orbis. The collaborative project on Thursday announced its second action, with the approval of a new indication for AstraZeneca’s cancer drug Calquence (acalabrutinib).

The NASEM report further explains 14 MRAs involving medicine regulators globally, including ones between Canada and Switzerland, the EMA and Canada, the EU and Israel and the EU and Japan.

The committee is calling on policymakers to expand the scope and substance of such mutual recognition agreements, including the one between FDA and EMA, to go beyond GMP inspections and include matters related to good clinical practices, good laboratory practices and good pharmacovigilance practices.

“Lower-resourced regulatory authorities should consider the risks and benefits of unilateral recognition of the regulatory decisions of trusted regulatory authorities when doing so would facilitate better public health decision making in the context in which the lower-resourced regulatory authority functions,” the report says.

Committee members in a webinar on Thursday also stressed that lower-resourced regulators must have the same product, manufactured at the same site, as the higher-resourced countries. They said that often companies will use a rest-of-the-world version of a product that’s different from what’s used in high-income countries.

“Being able to truly compare apples to apples with these products can help low-income countries use the reliance mechanism,” Alastair Wood, professor of medicine (emeritus) at Vanderbilt University said.

They also explained how regulators should be able to share rejection letters sent for specific products and the reasoning behind such decisions.

Martha Brumfield, president and CEO of the Critical Path Institute, said that industry needs to be at the table in these discussions because, “So much can be learned from failures or why a clinical trial did not meet its endpoint. Sharing that information is definitely a positive contribution to public health.”

Several committee members also discussed the controversy around registering clinical trials when that initiative first took shape. But now, the practice is commonplace and no company would begin a trial without looking at to see what’s out there.

Brumfield explained how expanding the scope of MRAs can take time because regulators need to build trust and confidence in one another.

Another recommendation from the report called on regulatory authorities to co-create a results framework with clear metrics and processes for monitoring and measuring their arrangements’ results in enhancing public health and other benefits and associated regulatory efficiencies.

Committee members also explained how global public health is not enhanced by industry submitting the same applications to multiple regulators and going through multiple, similar review processes.

NASEM Report: Regulating Medicines in a Globalized World


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