Regulatory Entities: Separation with Cooperation

United States

Pharmaceutical production in the US is primarily regulated at the federal level by the US Food and Drug Administration (FDA). The FDA approval process for new drugs and biological products follows an established path consisting of multiple phases:

  • One phase of animal testing
  • Three phases of human testing to be completed before a product can be made available on the market
  • One final phase of human testing that continues after the release of a product

For non-drug and non-biological medical products, the FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating companies that manufacture, repackage, re-label and/or import medical devices and radiation-emitting medical products such as lasers, X-ray systems and ultrasound equipment.

European Union

Regulation in the EU is an understandably more complex task; the European Economic Area (EEA) alone comprises 31 countries (28 EU member states plus Iceland, Liechtenstein and Norway). Various national regulatory authorities within the EEA form a partnership with the European Commission (EC) and the European Medicines Agency (EMA) known as the “European medicines regulatory network,” which works to ensure that patients within the EU are provided with reliable access to high-quality, effective and safe medicines.

This network is supported by thousands of experts from across Europe who provide scientific advice, assessments of new medicines and new safety information. Regulation-related information and advice is also shared within the network, including:

  • Reported side effects of medicines
  • Oversight of clinical trials
  • Protocols for inspection of a manufacturer’s medical products
  • Compliance with:
    • Good clinical practice (GCP)
    • Good manufacturing practice (GMP)
    • Good distribution practice (GDP)
    • Good pharmacovigilance practice (GVP)

Transcontinental cooperation

Despite the differences in organizational structure and approach, the EC, the EMA and the FDA manage to coordinate their work on numerous fronts, seeking to streamline efforts, share best practices and avoid wasteful redundancies while promoting human and animal health. This is accomplished in several ways:

  • Confidentiality arrangements
    • Applications for scientific advice, orphan designation, marketing authorization and post-authorization variations
    • Applications for agreement of pediatric investigation plans
    • Good manufacturing practice (GMP) and good clinical practice (GCP) inspection planning and reports
    • Legislation and guidance documents.
    • Pharmacovigilance data related to:
      • Adverse drug reactions
      • Safety concerns arising from periodic safety update reports
      • Post-authorization obligations and inspection reports
  • Cluster activities
    • Regularly held virtual meetings in “clusters” — i.e., areas of cooperation focusing on specific topics and therapeutic areas deemed to require an intensified exchange of information and collaboration
  • Mutual recognition agreement and GMP compliance, allowing EU and FDA authorities to:
    • Rely on each other's GMP inspections for some types of medicines
    • Waive batch testing of products on entry into their territories
    • Share information on inspections and quality defects
  • Parallel scientific advice, allowing EU and FDA authorities to:
    • Exchange views on scientific issues with companies during the development phases of medicinal products
    • Deepen understanding of scientific and regulatory decisions
    • Optimize medicine development and avoid unnecessary duplication

Helping researchers and labs maintain compliance with standards