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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM’s International Outreach Activities in China and South Africa

by Brandi Robinson, Executive Manager for the United States Delegation to the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF), Office of New Animal Drug Evaluation

FDA’s CVM and Office of International Programs (OIP) perform a number of outreach activities with different countries to help FDA fulfill its public health mission.

As part of the outreach activities, CVM and OIP help organize and participate in workshops abroad.  These international workshops give regulatory officials and scientific experts in the fields of animal drug review and human food safety a chance to work together to address mutual public health issues.  This collaborative effort protects public health and makes sure safe and effective drugs are available for animals.

In September 2009, CVM participated in workshops in the People’s Republic of China and the Republic of South Africa.  The workshops allowed CVM to continue important interactions with its counterparts in both countries.

Reaching Out to China

At the invitation of the China Institute of Veterinary Drug Control (CIVDC) in China’s Ministry of Agriculture, a group of CVM employees traveled to Beijing and Nanjing, China to attend meetings on various public and animal health-related topics.   

CVM’s first stop was Beijing, where the group met with leaders of CIVDC and gave an overview of CVM’s public and animal health responsibilities.  CIVDC also presented an overview of the Chinese organization and its responsibilities.

While in Nanjing, the capital of Jiangsu Province, the CVM group participated in a joint China-U.S. workshop on the pre-approval requirements for animal drugs.  The workshop, co-sponsored by the CIVDC office in Jiangsu Province and CVM, gave participants from each country the chance to interact with the other’s regulatory officials and scientists.  At the workshop, each member of the CVM group gave a presentation on a part of the U.S. review process for animal drugs.

Following the workshop, several in-depth discussions were held between CVM and CIVDC comparing and contrasting the U.S. and Chinese regulatory systems.  The discussions also covered a number of scientific challenges facing both countries.

CIVDC Secretary General, Deputy Director-General Xiangdong Li:  “…I believe we are building a mutual understanding, learning and communication platform between our two organizations.”

The group from CVM also attended the China 2nd Congress of Veterinary Medicine in Nanjing.  As part of the Congress’ International Forum, several CVM employees gave presentations on and participated in question-and-answer sessions on the U.S. review process for animal drugs.

Both the workshop and the Congress gave CVM the opportunity to meet colleagues in China and have candid discussions about scientific and regulatory issues. 

Continued interaction between China and the United States is needed to establish additional international standards for animal drugs.  Developing regulatory policy through joint scientific discussions is very helpful in establishing those standards.

CVM thanks CIVDC for hosting the group from FDA and for co-sponsoring the Nanjing workshop.  CVM appreciates the cordial welcome from CIVDC and the open discussions that were held throughout CVM’s visit to China.

Reaching Out to South Africa

In another outreach activity abroad, a group of CVM employees traveled to Pretoria, South Africa, to lead a 3-day workshop at the University of Pretoria. South Africa’s Department of Health and CVM co-sponsored the workshop, and it also drew significant attention from South Africa’s Department of Agriculture, Forestry and Fisheries.  The idea to have a joint South Africa-U.S. workshop came out of several discussions on international outreach and collaboration between Dr. Bernadette Dunham, Director of CVM, and Ms. S. Margaret Molefe, Deputy Director of Chemistry Safety, Directorate:  Food Control, in South Africa’s Department of Health. 

The workshop in Pretoria covered many aspects of the animal drug review process in the United States and South Africa.  Participants from both countries discussed the importance of a holistic approach to reviewing animal drugs.  A more holistic approach involves looking at all sections of the review process together, rather than as separate pieces, to make sure that the drug is safe, effective, and manufactured to appropriate quality standards. Another discussion topic was the scientific rationale of the human food safety review of animal drugs for food-producing animals in the United States.

The joint workshop was a great success that formed the basis for future interactions and increased collaboration between the United States and South Africa.

Dr. K.S. Chetty, Acting Director-General:  Health Service Delivery of South Africa’s Department of Health, thanked Dr. Dunham “for providing the workshop with valuable, knowledgeable technical and scientific experts and generous financial support in making [it] a success.”

CVM thanks South Africa’s Department of Health for organizing and co-sponsoring the workshop and Ms. Molefe for her support.  CVM also thanks South Africa’s Department of Agriculture, Forestry and Fisheries.  CVM appreciates the friendly reception from the South African officials.

Highlights from CVM’s Trips Abroad:

While in China, CVM:

  • met with CIVDC leaders, including Secretary of the Party Committee and Deputy Director-General Xiandong Li and Deputy-Director General Zhongze Feng
  • participated in the China-U.S. Technical Workshop on Animal Drug Pre-Approval Requirements and presented information on:
    • the review process for animal drugs
    • the Minor Use Minor Species Program
    • the U.S. National Antimicrobial Resistance Monitoring System (NARMS) program
    • future opportunities for international collaboration
  • participated in the China 2nd Congress of Veterinary Medicine and presented information on the review process for animal drugs

At the South Africa Workshop, CVM:

  • presented an overview of the review process for animal drugs
  • presented an overview of the Minor Use Minor Species program
  • presented an overview of the use of pharmacokinetic and pharmacodynamic information in evaluating drugs for animals
  • gave detailed presentations on
    • determining drug effectiveness, target animal safety, and environmental safety
    • human food safety, including toxicology, residue chemistry, and microbial food safety 

CVM Travelers

China Trip:

  • Dr. Steven Vaughn, Director, Office of New Animal Drug Evaluation (ONADE)
  • Brandi Robinson, Executive Manager for the U.S. Delegation to the CCRVDF
  • Dr. Merton Smith, Special Assistant for International Activities for CVM
  • Dr. Steven Yan, Senior Microbiologist, ONADE
  • Dr. Julia Oriani, Master Reviewer Residue Chemist, ONADE
  • Dr. Tong Zhou, Senior Toxicologist, ONADE
  • Dr. Shaohua Zhao, Senior Microbiologist, Office of Research
  • Two members from FDA’s Office in Beijing, China joined the CVM travelers,  Michael Kravchuk and Brenda Uratani

South Africa Trip:

  • Dr. Steven Vaughn, Director, ONADE
  • Brandi Robinson, Executive Manager for the U.S. Delegation to the CCRVDF
  • Jon Scheid, International Liaison to the Center Director
  • Dr. Lynn Friedlander, Team Leader, Residue Chemistry Team, ONADE
  • Dr. Abe Tobia, Senior Toxicologist, ONADE
  • Sylvia Piñeiro, Senior Microbiologist, ONADE