Medicine regulators should increase collaboration, says new report

According to new research, medicine regulatory authorities (RAs) should strengthen co-operation with other countries’ regulatory bodies to ensure the quality, safety and efficacy of drugs.

The report, from the US National Academies of Sciences, Engineering, and Medicine contains recommendations to promote information-sharing among RAs.

The research highlights that an estimated 40 percent of medicines and 80 percent of active pharmaceutical ingredients (APIs) used in the US are imported. As other countries can have different regulations regarding medicines and inspection reports are often confidential, safety information is difficult to obtain.

Although mutual recognition agreements (MRAs) can allow an RA to consider another RA’s work, entering one of these arrangements does not relinquish an RA’s decision-making responsibilities, says the report.

To improve this process, impediments to information-sharing should be removed, suggest the research. RAs need to consider sharing full, unredacted reports to help counties make more informed decisions.

Potential benefits of this would include faster access to high-quality medicines, better identification of substandard or falsified medicines before approval or exportation and prevention of duplicative work.

A stakeholder-driven strategy would improve collaboration among RAs, says the report, by:

• Increasing information-sharing and transparency of regulatory work products across the lifecycle of medicines
• Making unredacted assessment and inspection reports available to other trusted regulators, especially to lower-resourced regulators
• Leveraging limited resources to maximise efficiency and quality
• Reducing the burden of redundant regulatory activities directly and indirectly impacting regulators, patients and industry.

“Many industries – such as banking and telecommunication – operate seamlessly across national borders. Today’s medicines are global commodities, so the regulation of medicines should function just as seamlessly,” said Alastair Wood, Emeritus Professor of Medicine and Pharmacology at Vanderbilt University, who chaired the committee that wrote the report. “RAs need to be able to use the best science, the best expertise and the best resources to make informed decisions to protect the health of millions of people.”