US and EU Regulators Seek to Reduce Pharma Inspections
As a key step toward reducing the need to inspect every drug production facility in Europe, FDA is looking to share un-redacted inspection reports with trusted European regulatory authorities. More extensive information exchange would help move forward a Mutual Recognition Agreement (MRA) with the European Medicines Agency (EMA), which has been in the works for several years. The aim is to identify facilities with strong records of compliance with GMPs based on inspections by competent local inspectorates.
FDA has been receiving un-redacted inspection reports from EMA for years, but current FDA policy prevents sharing of “trade secret” information that appears in field inspection reports, explained Dara Corrigan, associate commissioner for global regulatory policy at FDA. Speaking at the ISPE/FDA/PQRI quality manufacturing conference in Bethesda, MD, this week, she noted that the Department of Justice, Treasury, and Securities and Exchange Commission are able to share sensitive, classified information with certain European Union (EU) authorities. Such policies, she believes, provide a strong precedent for FDA to act similarly. Legislation enacted in 2012, moreover, permits FDA to share confidential information in situations where the agency can certify that the other country can keep such information secret.
Source: BioPharm International