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  1. CDER International Program

International Agreements & Information Sharing

The Food and Drug Administration (FDA) fosters partnerships with counterpart foreign government agencies and international organizations. The tools that FDA uses to set up and memorialize these partnerships include two categories of International Arrangements: Cooperative Arrangements (which include Memoranda of Understanding and similar documents) and Confidentiality Commitments.

A Cooperative Arrangement is a written understanding that FDA can establish with one or more foreign governments or international partners that describes the willingness and good-faith intentions of FDA and its counterpart(s) to engage in activities. Even with a Cooperative Arrangement in place, the FDA cannot share non-public information unless a Confidentiality Commitment exists. Cooperative Arrangements allow for FDA to engage with foreign regulators on various emerging regulatory topics to advance public health interests.

A Confidentiality Commitment (CC) is a document that establishes a legal framework for FDA to share certain kinds of non-public information with FDA counterparts in foreign countries and international organizations as part of cooperative law enforcement or regulatory activities. A CC must be in place before FDA can share non-public information with a counterpart, but a CC never requires FDA (or its counterpart) to share information. The ability to share certain types of information with foreign pharmaceutical regulatory authorities, allows CDER to collaborate in addressing potential public health concerns, offer better regulatory guidance in its review activities, and improves the Agency’s ability to perform its role in providing regulatory oversight. CDER shares non-public information with foreign counterparts in reliance of confidentiality commitment through many mechanisms including through clusters, and working groups, in response to counterpart requests or CDER’s own proactive information sharing with foreign counterparts and other channels for information sharing.

All “non-public” information must be shared following procedures outlined in Staff Manual Guide 2830.3 and in compliance with CDER-specific procedures. Please contact: William.Lewallen@fda.hhs.gov and CDERINTLEXEC@fda.hhs.gov for international regulatory inquiries.

Clusters

FDA engages with foreign pharmaceutical regulatory authorities on a bilateral and multi-lateral basis to work together on special topics and therapeutic areas identified as requiring an intensified exchange of information and collaboration through its clusters. A list of current ongoing clusters in which FDA participates is provided in the following table.

Center for Drug Evaluation and Research Ongoing Clusters

Type of cluster

Cluster Objective

Regulatory Participants

Biosimilars (est. 2011)

 

Achieve a common understanding of each Agency’s regulatory approaches to biosimilar development as based on internal policies, guidance documents, and regulations.

 

Provide a forum for a discussion of general and product/class-related scientific review issues and foster alignment in approaches to scientific evaluation whenever possible.

 

Offer a confidential forum for exchange of draft documents, policies in development, and more detailed information supporting the scientific basis for decision making.

  • FDA (CDER & CBER)
  • European Medicines Agency (EMA)
  • Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, (PFSB/MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Health Canada (HC)

 

Non-clinical oncology (est. 2011)

 

Examine scientific issues for product evaluations with the goal of understanding divergent requirements or safety concerns. Discuss respective agency’s guideline requirements in oncology and exchange data/publications of common interest.

 

  • FDA/CDER
  • EMA

 

Oncology-hematology medicinal products (est. in 2004)

 

Share clinical review information, with a strong focus on clinical and statistical issues, of medicines to treat cancer under review by the agencies. Focuses on marketing-authorization applications under review and at pre-submission. This cluster also focuses on requirements for non-clinical studies and identification of non-clinical safety issues for products under clinical trials.

 

  • FDA (CDER & CBER)
  • EMA
  • PFSB/MHLW and PMDA,
  • HC
  • Therapeutic Goods Administration of Australia (TGA)
  • Swiss Agency for Therapeutic Products, Swissmedic

 

Pharmacogenomics (est. 2005)

 

Development and harmonization of international guidelines on issues related to pharmacogenomics. This Cluster exchanges information on pharmacogenomics-related product issues under parallel assessment and on pharmacogenomics policy-related issues. EMA and FDA accept joint applications for qualifications of biomarkers/ clinical outcome assessments (COAs).

 

  • FDA/CDER
  • EMA
  • PMDA/MHLW
  • HC
  • TGA
  • Swissmedic

 

Pharmacometrics / Modelling and simulation (est. 2016)

 

Exchange information and perspectives on pharmacometrics, including guidelines, workshops, publications, and products under parallel assessment.

 

 

  • FDA/CDER
  • EMA
  • PMDA/MHLW
  • HC
  • TGA
  • Swissmedic

 

Pharmacovigilance (est. 2013)

 

Share information on drug safety issues, providing advance notice of anticipated regulatory action, public information and communication prior to decision-making and publication. Focuses on product-related risk assessments especially emerging safety concerns, policies, guidance documents and regulations are typically exchanged during the cluster meetings.

 

 

  • FDA/CDER
  • EMA
  • PMDA/MHLW
  • HC
  • TGA
  • Swissmedic

 

 

 

 

 

 

Rare diseases (est. 2016)

 

Exchange information on the development and scientific evaluation of medicines for rare diseases, including on conducting clinical trials in small populations, obtaining preclinical evidence to support development programs, risk management strategies for long-term safety issues and the design of post-marketing studies.

 

  • FDA/CDER
  • EMA
  • PMDA/MHLW
  • HC
  • TGA
  • Swissmedic

Resources for You

Confidentiality Commitments

Clusters

Related External Links:

Links to clusters