EU, US Commit To Sharing Full Inspection Reports To Supplement GMP Mutual Recognition
Executive Summary
EU and US drug regulators have signed a new confidentiality commitment that allows both parties to exchange full medicine inspection reports with each other. This was not possible before.
Drug regulatory authorities in the EU and the US will be able to exchange full medicine inspection reports with each other under a new confidentiality commitment signed by the two regions. The initiative aims to improve patient safety on both sides of the Atlantic and to allow EU and US regulators to make better use of their inspection resources.
The new confidentiality commitment, involving the European Commission, the European Medicines Agency and the US Food and Drug Administration, will help with the implementation of the EU-US mutual recognition agreement, under which both sides have agreed to rely on each other’s good manufacturing practice (GMP) inspections conducted within their respective jurisdictions. The EMA said the MRA was on track to become operational from Nov. 1. (Also see "EU, US Finally Agree On Mutual Recognition Of GMP Inspections" - Pink Sheet, 2 Mar, 2017.) (Also see "US Reliance On EU Drug Facility Inspections Begins In November" - Pink Sheet, 5 May, 2017.)
The new confidentiality commitment is not restricted to sharing information on GMP inspections. It will enable, more broadly, “the exchange of non-public information related to EU- and FDA-regulated medicinal products for both humans and animals, including pre- and post-market activities,” the EMA told the Pink Sheet. The new commitment entered into effect on the day it was signed.
While the EU and US have had confidentiality arrangements in place since 2003 that allow both regions to exchange confidential information as part of their regulatory and scientific processes, complete exchange of information was not possible under these arrangements.
The EMA explained that until now, the FDA used to redact trade secret information from the inspection reports before sharing them with the EU regulators. Under the new confidentiality commitment, which came into play with immediate effect, “the FDA can share inspection reports of manufacturing sites without redacting any trade secret information included therein,” the agency said.
The EMA said the sharing of full inspection reports would allow both EU and US regulators to make decisions based on findings in each other’s inspection reports and to make better use of their inspection resources to focus on higher-risk manufacturing sites.
The EMA explained that it operates a risk-based inspection program that takes into account inspection information from trusted authorities when deciding on the need for an inspection. “Having the full inspection report including previously redacted trade secret information will facilitate the decision making process,” it said.
The EMA described the development as a “milestone” in the ongoing implementation of the EU-US mutual recognition agreement on GMP and would help in further strengthening the EU-US relationship. “This enhanced cooperation with US regulatory authorities will improve the EU's ability to identify and address problems at factories before they become a public health risk,” the EC said.
From the editors of Scrip Regulatory Affairs.