CVM’s role in contributing to global leadership in the regulation of veterinary drugs and feeds is broad and demanding. During the last two years the FDA established offices in a number of countries and organizations to help promote awareness and understanding of FDA programs and to promote harmonization of product standards and conformity assessment procedures. Currently FDA has experts and other staff at the U.S. Mission to the European Commission in Brussels; at the European Medicines Agency in London; at the European Food Safety Authority in Parma, Italy; in three locations in China (Beijing, Shanghai, and Guangzhou); in two locations in India (Mumbai and New Delhi); in San Jose, Costa Rica; in Santiago, Chile; in Mexico City, Mexico. Soon more FDA staff will be located in Pretoria, South Africa and in Amman, Jordan. These FDA staff members who are located abroad have participated in a large number of outreach activities with government and industry organizations located in their regions. In addition, many CVM regulatory and scientific experts have participated in these outreach scientific and technical meetings and in workshops designed to build relationships with colleagues from many foreign governments (e.g., China, South Africa, Chile, Costa Rica, Canada, and the European Union) and have assisted in capacity building through education, webinars, and technical assistance with regulatory counterparts. It should be emphasized that all of these interactions embrace a multidisciplinary approach to the global health needs of humans, animals, and their environment based on scientific principles and empirical data. CVM has organized and led a number of meetings and workshops designed to explain the U.S. regulatory requirements for veterinary drugs and feeds and their scientific and public health and animal health protection foundations. Some recent meetings include the following:
Workshop in Paraguay
CVM participated in a September 2008 workshop entitled “Overview of Current Human Food Safety Requirements for Antimicrobial Veterinary Drugs” was presented in conjunction with the XIVth International Seminar on Harmonization and Control of Veterinary Medicines in America, co-sponsored by the CAMEVET and the OIE, and held in Asunción, Paraguay. Regulatory officials from Latin American countries attended the workshop. The workshop used a formal presentation format and focused on regulation of antimicrobial drugs for use in food-producing animals and introduced the attendees to CVM Guidance for Industry #152 and #159.
Workshop in Mexico
In August 2009 CVM participated in a workshop entitled “Various Regulatory Aspects of Veterinary Drugs and Biologics” was presented in conjunction with the XVth International Seminar on Harmonization and Control of Veterinary Medicines in America co-sponsored by the CAMEVET and the OIE, and held in Guadalajara, Mexico. Regulatory officials and industry representatives from Latin American countries attended the workshop. Using a formal presentation format, this workshop focused on both pre-approval and post-approval topics. Additionally, a presentation was included from the U.S. Department of Agriculture’s (USDA’s) Animal and Plant Health Inspection Service (APHIS) on the approval of biologics (vaccines).
CVM Co-sponsored the Animal Drug Residue Safety Workshop in Pretoria, Republic of South Africa in September, 2009
In January 2010 CVM participated in a workshop entitled “Republic of South Africa and FDA Centre for Veterinary Medicines Joint Workshop on Animal Drug Residue Safety” was held in Pretoria, Republic of South Africa. Using a formal presentation format, this workshop focused on both pre-approval and post-approval topics relating to veterinary drug regulation. The workshop was attended by regulatory officials and faculty members from the Veterinary College, University of Pretoria, Ondestepoort, RSA.
Workshop in Costa Rica
CVM participated in a workshop entitled “Safety of Residues of Veterinary Drugs in Edible Tissues of Food Animals” was held in San José, Costa Rica. Using a formal presentation format, this workshop focused on both pre-approval and post-approval topics relating to veterinary drug regulation. Additionally, one afternoon consisted of a hands-on exercise that focused on evaluating data packages such as those typically submitted to support new animal drug approvals in the USA. Publicly accessible summary reports (Freedom of Information Summaries and the JECFA monograph reviews) were identified and prepped to provide the materials for the exercise. Government regulators and industry representatives of the Central American countries participated in the workshop and shared insight on the drug approval process in their respective countries. Support from OIP facilitated the attendance of the representatives from the Latin American countries and the active participation of the FDA/LA officials in Costa Rica introduced the attendees to the FDA officials on the ground in Central America.
Information-sharing Regulatory Workshop in Guadalajara, Mexico Sponsored by the FDA/USDA
In August 2009 CVM participated together with APHIS in a workshop that covered the regulatory aspects of veterinary drugs and biologics. Topics included registration of generic drugs, drug withdrawals, pharmacovigilance, combination drugs, and the stability of biologics.
International Workshop on Detection of Antimicrobial Drug Residues and Antimicrobial Resistant Microorganisms in Food of Animal Origin in Guangzhou, China
In September of 2009 the CVM sent a six-member delegation to Guangzhou, China to lead a workshop and make presentations to the Chinese AQSIQ. This workshop (entitled “International Workshop on Detection of Antimicrobial Drug Residues and Antimicrobial Resistant Microorganisms in Food of Animal Origin”) covered a variety of topics including human food safety, updates on current laboratory analytical detection methods for drug residues and microorganisms, risk assessment principles and procedures, field monitoring and compliance programs, and CVM’s international activities as they relate to food safety and drug approval. As a result of this workshop, representatives from AQSIQ plan to visit the CVM’s home offices in August of 2010.
Organization of the China-US Technical Workshop on Animal Drug Pre-Approval Requirements in Nanjing, China
In September 2009, CVM representatives participated in this workshop in Nanjing, China. The CVM delegation presented information on the U.S. pre-approval animal drug evaluation process including; overview of the application of the U.S. New Animal Drug review process, the U.S. program for reviewing drugs for minor species and for minor uses, the NARMS, the use of pharmacokinetic and pharmacodynamic information in drug evaluation, and opportunities for participating in international standard-setting programs including VICH and Codex Alimentarius.