The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment. The commitment to share confidential info marks a milestone in the process to implement mutual recognition of drug manufacturing facility inspections.
Outsourcing-Pharma reports that the confidentiality commitment allows FDA to share trade secret information (TSI) and other nonpublic drug information related to inspections or investigations. FDA told Outsourcing-Pharma that “this commitment will strengthen the use of each other’s drug inspection findings and will result in greater efficiencies for both regulatory systems.”1
Agreement allows for resource reallocation
An FDA spokesperson explains that “by utilizing each other’s complete, unredacted inspection reports, the commitment will help the FDA and the EU to reallocate resources for the inspection of drug manufacturing facilities, with potentially higher public health risks, outside of the US and the EU.”1 Theoretically, the agreement will allow for areas of higher risk to receive a bigger cut of the existing resources.
The path toward mutual recognition
The confidentiality commitment marks another step in the enactment of the mutual recognition agreement announced in March 2017. The agreement promised a new framework for pharmaceutical inspections for the United States and European Union. EMA states that “the new confidentiality commitment formally recognizes that FDA’s EU counterparts have the authority and demonstrated ability to protect the relevant information.”1 It is worth noting that unredacted inspection reports will not be shared with EU country inspectorates until a confidentiality commitment is signed with each EU country.
Mutual recognition possible for GCP?
Outsourcing-Pharma spoke with the head of compliance and inspections department at EMA, Anabaela Marcal, PharmD, about the possibility of mutual agreement for good clinical practice (GCP). Marcal admits that both FDA and EMA “do rely on each other” regarding GCP, but different legal and regulatory frameworks exist between countries. “GMP was easier to agree on…[while GCP] is something that we are probably in the future working towards.”1
Pearl Pathways routinely completes audits of manufacturing facilities for our clients. Complying with FDA, European, or other global device, biopharma, or diagnostic regulations is an ongoing process. Click here to learn more about how we help create efficient and compliant GCP, GMP, and GLP quality systems, third party management plans, and risk management programs.