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        Guidance, Compliance, & Regulatory Information

CDER International Program

                        
                International Regulatory Harmonization
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          CDER International ProgramGuidance, Compliance, & Regulatory Information CDER International Program
  	
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    PrintThe Center for Drug Evaluation and Research (CDER) has a mission to ensure the availability of safe and effective medicines to improve the health of people in the United States. Recognizing that pharmaceutical development, manufacturing and marketing is now a global enterprise, with more than half of CDER-regulated products manufactured abroad, CDER must engage with other pharmaceutical regulatory authorities, global industry and other international stakeholder organizations to realize its mission. The CDER International Program helps facilitate engagement with these stakeholders and represents FDA in related international venues.

CDER’s work with foreign stakeholders enables progress in the harmonization of scientific and technical standards and regulatory requirements among regulatory authorities. This regulatory harmonization helps improve efficiency in drug development and registration processes and helps to minimize unnecessary animal studies and duplication of work for the clinical studies needed to meet regulatory requirements for marketing in different regions of the world.

CDER also engages closely with foreign regulatory authorities to share information on regulatory best practices and scientific advances, as well as information about potential and emerging threats to public health. This work is accomplished through CDER’s engagement in various international venues and through bilateral and multilateral engagements coordinated by the CDER International Program.

CDER’s International Program is led by the Associate Director for Strategic Initiatives and the International Program staff is located in CDER’s Office of the Center Director.

Contact Information:

Theresa Mullin, PhD
	Associate Director for Strategic Initiatives
	William Lewallen, FAC-P/PM
	International Program Analyst
	Tisha Washington
	Project Specialist
	Jill Adelberg
	ICH Coordinator
	Brooke Dal Santo
	Public Health AnalystFor more information contact: CDERINTLEXEC@fda.hhs.gov

                                                                                  Content current as of:
      03/02/2023
                  
                   
Regulated Product(s)
		 DrugsCDER International Program                
                          

                        International Regulatory Harmonization
          International Agreements & Information Sharing
          Partnerships and Collaborations
          Resources for Foreign Pharmaceutical Regulatory Authorities
 
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