The Practical Implications of FDA and EMA Sharing Confidential GMP Information
​[Posted on: Thursday, September 7, 2017]

FDA and EMA signed a mutual confidentiality arrangement this month which commits both agencies to share all information about manufacturing operations located in either region including trade secret and non-public information. The agreement will become effective on 1 Nov 2017 and will be in transition phase till July 2019 giving both agencies time to work out any issues due to the arrangement. The agreement covers most drugs and most biologics but does not include cellular and gene therapies, human blood and plasma products, and investigational products. Under the arrangement, the two agencies will share each other’s GMP audits reports in full, recognize GMP certificates issued by each other, and meet every three months to discuss any issues with an aim of minimizing repeat audits of the same site unless there are major noncompliance issues. The sharing of GMP audit reports applies to any audit conducted by either agency in any country, not just the EU and US. For example, EMA will share its reports for GMP audits conducted in countries outside EU. When EU auditors visit a site in India or China, the audit report will be available to FDA for review. This could have a huge practical implication. In the recent past, there have been times when EMA auditors found issues during GMP audits in Asia but it took several months before FDA could visit the same sites to confirm or disagree with the EMA audit. Similarly FDA conducted many audits whose reports were not available to EU auditors. All that would change. Now FDA will simply have access to the findings by EMA in full details and possibly could ask additional follow-up questions of the auditors. European regulators have done similar agreements with a few other countries: Canada, Australia, Japan, Switzerland, New Zealand and Israel. Prominent missing countries are India and China in a tacit acknowledgement that a robust compliance program does not exist in these countries despite contributing major share to the global drug supply chain. The harmonization of GMP audit practices across major regulatory agencies should make it easier for regulators to catch defaulters and make it easier for compliant organizations to do business without worrying about unnecessary repetitious audits. The good news for manufacturers is that if they pass one Agency’s audit, they will automatically pass the audit by the other. For the regulators, it should also help regulators get closer to the stated goal of timely audits of all manufacturers.