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Jill Wechsler is Pharm Exec's Washington Corespondent
A NASEM report stresses the importance of information sharing by biopharma companies and cooperation among regulatory authorities.
Greater cooperation among regulatory authorities (RAs) in all regions would advance public health by speeding access to new therapies, optimizing the use of human and financial resources, and better managing drug shortages and health emergencies. To this end, an expert committee formed by the National Academies of Sciences, Engineering and Medicine (NASEM) calls for more sharing of information through mutual recognition agreements (MRAs) that facilitate reliance on the work of other RAs to inform regulatory decisions.
To advance such important goals, biopharma companies should agree to share unredacted inspection reports, rejection letters for specific products, and other documents containing what industry considers confidential commercial information, according to the report on “Regulating Medicines in a Globalized World”. The panel calls for extending the current MRA between FDA and the European Medicines Agency (EMA) from its current focus on good manufacturing practice (GMP) inspections of drug facilities, which was fully implemented only last summer, to inspections for vaccines and biologics. In addition, US–EMA agreements could also apply to oversight of good clinical practices, laboratory testing, and pharmacovigilance.
The NASEM report, which was published Nov. 21, 2019, was requested by FDA’s Office of Global Policy & Strategy to gain added perspectives on ways to further harmonize regulatory policies and to extend MRAs to additional activities and regions. It describes a broad range of MRAs and other agreements involving the EMA and regulators in Canada, Switzerland, Japan, and other nations. One aim is to establish such agreements with lower-resourced regulatory authorities in order to improve public health through earlier access to new therapies. A main point, though, is that all authorities, including those with limited resources, want access to complete information to be comfortable in relying on regulatory decisions by others.
The panel, which was chaired by Alastair Wood of Vanderbilt University, notes that only a few years ago, biopharma companies were very reluctant to register planned clinical trials on the ClinicalTrials.gov website, but now regard that as standard procedure. The hope is that this experience with sharing clinical trial information will open the door for industry to disclose additional proprietary data. Greater information sharing among regulators, according to these experts, would make better use of limited scientific and technical expertise; support further harmonization of regulatory standards and policies; lead to more informed policy decisions; and avoid waste from redundant tests and reports.