Foreign Inspectional Collaborations
FDA has had to evolve from a domestically-focused regulatory agency to one that is part of a larger global health organization while continuing to ensure the quality of products that enter the United States. FDA regulates products from more than 150 countries. In addition, approximately 40% of finished drugs and 80% of manufacturers of active pharmaceutical ingredients come from outside the US. This poses multiple challenges when the supply chain stretches across the globe. It also stresses the importance of FDA’s global partnerships to ensure quality products within our own borders.
With so many imported products entering the US, Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012 which included provisions to improve the safety and integrity of imported drugs sold in the US. Several of the provisions focused on FDA’s inspectional activities overseas with the goal of partnering with our foreign regulatory colleagues to leverage resources through information sharing and recognition of foreign inspections.
CBER continues to be active in this area. Since 2010, FDA has been an official member of the Pharmaceutical Inspection Co-operation Scheme (or PIC/S). The mission of PIC/S is "to lead the international development, implementation and maintenance of harmonized Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products." To this end, it develops and promotes harmonized GMP standards and guidance documents; trains inspectors; assesses (and reassesses) inspectorates; and facilitates the cooperation and networking of medical product inspectorates. CBER has historically been most active in the PIC/S working group on human blood, tissues and cells.
CBER joins CDER in an Agency collaboration with the EMA known as the Good Clinical Practice Initiative. The initiative was launched after an 18-month pilot phase that began in 2009. Inspections of clinical trial sites by both the FDA and the EMA seek to ensure the integrity of data submitted to support product licensure/approval and the safety of clinical trial subjects. The initiative seeks to address the current challenges of the increasing globalization of clinical trials and the reality that the same trials are used to support Marketing Authorization Applications to the EMA and New Drug Applications and Biologics License Applications submitted to FDA. The objectives of the EMA-FDA GCP Initiative include:
- to conduct periodic information exchanges in bimonthly teleconferences on GCP-related activities, including information specific to GCP inspections (study/site selection and inspection outcomes) to improve coverage
- to conduct collaborative GCP inspections to build mutual understanding and confidence in our respective inspection processes and to share best practices
- to share information on the interpretation of GCP which can inform regulatory guidance, legislation, policy and position papers
- to identify and act on areas where greater convergence could be achieved to the benefit of clinical research
On May 12, 2014, the Agency announced the Mutual Reliance Initiative, a strategic Agency program designed to deepen our reliance on the European Union (EU), specifically for the oversight of good manufacturing practice (GMP) inspections of human drugs. Managed jointly by Global Operations (GO), CDER and CBER, this initiative builds upon our existing relationships with the European Medicines Agency (EMA) and member states of the EU, the European Commission (EC), and the European Parliament. It complements the ongoing work of CDER, CBER, ORA, and OIP to enhance pharmaceutical quality through international collaboration, and also FDA’s work in implementing the FDASIA. The goal is to increase our exchange of information with the EC and the EMA that is critical to making decisions that protect the public health, allowing all parties to be more efficient and effective in targeting our resources for inspecting pharmaceutical operations.