Global Partnerships Yield Greater Efficiencies and Faster Access to Critical Medicines

By Elizabeth Miller  
Deputy Associate Commissioner for Medical Products  
Office of Inspections and Investigations  

Ensuring that drugs and biological drug products are safe and effective for Americans and their families is one of our top priorities at the FDA.  

In today’s closely interconnected global economy, some of the prescription, over-the-counter, generic, and biological drug products that many of us rely on are made outside this country. That’s why working closely with trusted and reliable international regulatory partners who inspect overseas pharmaceutical manufacturing sites to FDA’s high standards helps ensure medical product safety for U.S. consumers and animals (even our pets), while fulfilling our commitment to making the best use of finite inspectional resources.

OII’s Office of Human and Animal Drug Inspectorate and Office of Biologics Inspectorate are responsible for ensuring the compliance of this portion of regulated industry, which includes inspecting foreign human and animal drug manufacturers, including those making human biological drugs (like allergenic extracts, for instance) who wish to sell their products in the United States.

In addition to performing our own in-person and on-site inspections, OII uses Mutual Recognition Agreements, or MRAs, with partnering countries who have proven, rigorous regulatory capabilities. These MRAs provide the FDA with evidence-based insights and knowledge about global manufacturers, allowing the agency to determine whether or not a facility is manufacturing safe, high-quality drug and biological drug products. MRAs also benefit consumers by expanding and fortifying the global health security and safety net that serves us all.

How Do Mutual Recognition Agreements Work?  

Before the FDA accepts Good Manufacturing Practice, or GMP, data from any overseas regulatory authority, the agency conducts a thorough assessment of that entity to ensure it meets our gold standards of science and medical product oversight.

Through this rigorous process, we evaluate the authority’s regulatory framework, its inspection processes and resources, its quality system, and how it follows-up on adverse findings, among other important factors. Once a regulator is determined to meet our standards, the FDA then formally enters into an MRA with that partner. We also conduct regular reassessments of these partnering authorities to ensure they’re continuing to meet our high standards and making enhancements as needed.

MRAs allow the FDA and our partners to leverage each other’s inspection data to expand our knowledge of regulated industry and enhance our risk-based inspection site selection model. Currently, the FDA holds MRAs with the United Kingdom; the European Union, comprising its 27 member countries; and Switzerland.

How Do MRAs Benefit Consumers and Partnering Countries?

The MRAs we hold create efficiencies for the United States and foreign regulatory systems by avoiding duplication of inspections and enabling reallocation of resources toward the inspection of other drug manufacturing facilities across the globe. MRAs strengthen our understanding of industry and provide a more efficient and common-sense means of overseeing the thousands of manufacturing facilities outside the United States, which in turn makes our U.S. drug supply safer.

MRA Benefits:

• Enhanced compliance and quality. 
• Expanded global access to medicine.  
• Reduction in duplication of inspections. 
• Reduced cost to both the regulators and industry.

MRAs are a seminal tool in ensuring the availability of safe and effective medicines for American consumers. As technology steadily advances and the FDA optimizes our inspections around the globe, these instruments are sure to play an even greater role in keeping Americans safe, fostering the innovation of more life-saving products for those who need them, and building public trust.