Animal & Veterinary
What is VICH?
FDA Veterinarian Newsletter January/February 2000 Volume XV, No I
by Robert C. Livingston, Ph.D.
VICH is a trilateral (EU-Japan-U.S.) program aimed at harmonizing technical requirements for veterinary product registration. Australia and New Zealand participate as active observers. Its full title is the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products. VICH was officially launched in April 1996. The scope of the VICH program includes both pharmaceutical and biological veterinary medicinal products.
The globalization of the human and veterinary pharmaceutical industries led to the obvious conclusion that harmonization of registration requirements would have favorable impacts, not only on the industries but also on the consumers of pharmaceuticals. The increased trade in animal-derived food further emphasized the need for harmonization. Harmonization has the potential for decreasing developmental costs, decreasing the number of research animals required, reducing potential trade barriers and, most importantly, increasing the number of safe and effective drugs available to the consumer. Early initiatives in harmonization of animal drugs were the adoption in Europe in 1981 of standard requirements for veterinary product registration and the formation in 1985 by Codex Alimentarius of a Committee on Residues of Veterinary Drugs in Foods. Following the first International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in 1991, the Organization of International Epizootics (OIE) in 1994 set up an ad hoc group to discuss the harmonization of veterinary medicinal products. That group recommended that the organizational structure of ICH be used for veterinary medicinal products and proposed the membership and objectives of the VICH. Under the auspices of OIE, the Steering Committee of the VICH held its first meeting in April 1996, at which the membership and the working procedures were agreed and a work program established. The OIE, through its Collaborating Centre for Veterinary Medicinal Products, has recently been made an associate member of the VICH Steering Committee. The World Federation of the Animal Health Industry (COMISA) serves as the secretariat of VICH.
The objectives of VICH are included in its organizational charter:
- Provide a forum for a constructive dialogue between regulatory authorities and the veterinary medicinal products industry on the real and perceived differences in the technical requirements for product registration in the EU, Japan and the U.S., with the expectation that such a process will lead to a wider international harmonization.
- Identify areas where modifications in technical requirements or greater mutual acceptance of research and development procedures could lead to a more economical use of human, animal and material resources, without compromising safety.
- Make recommendations on practical ways to achieve harmonization in technical requirements affecting registration of veterinary products and to implement these recommendations in the three regions. Once adopted the VICH recommendations should replace corresponding regional requirements. These recommendations should focus on the essential scientific requirements needed to address a topic and should eliminate unnecessary or redundant requirements.
- The VICH should be conducted in a transparent and cost-effective manner and should provide an opportunity for public comment on recommendations at the draft stage.
The Steering Committee has the responsibility for managing the VICH process. This committee selects the topics for harmonization on the basis of a concept paper proposed by one of the parties to VICH or by a VICH Working Group. The Steering Committee establishes the appropriate Working Groups and appoints topic leaders and WG chairpersons. The Steering Committee approves the draft recommendations of the Working Groups prior to release for worldwide consultation and subsequent approval by the competent authorities of the EU, Japan and the U.S. The Steering Committee is composed of two delegates of the regulatory authorities and two delegates of representative industry associations from the three regions. Australia/New Zealand has observer status with one delegate representing government authorities and one delegate representing industry associations from the two countries. Each region has two coordinators, one from the regulatory authorities and one from the representative industry associations. The Steering Committee meets twice a year on a rotational basis. The host region appoints the chairperson.
The draft guidelines from the Working Groups must pass a 9-step approval process (see Table below.) The U.S. uses the notice and comment procedure to ensure a transparent process in the development of guidance documents. Notices of availability of draft and final guidance documents are published in the Federal Register at Steps 4 and 7, respectively. The guidance documents are considered implemented when the notice of availability of the final document is published or on the date specified if one is given. CVM guidance documents are available on our home page . The VICH documents are available on our home page. There may be slight differences in the language used in the documents to reflect FDA’s policies on guidance documents. These differences do not impact on the technical requirements described in the documents. For example, VICH uses the term guideline, but the U.S. uses the term guidance document.
The Steering Committee initially established five working groups: Efficacy requirements for anthelmintics, Ecotoxicity/environmental impact assessments, Good clinical practices, Quality, and Safety. Two additional working groups were subsequently formed: Biologicals and Pharmacovigilance. The results of these seven working groups were presented at the First Conference on International Harmonization of Veterinary Medicinal Products held November 16-18, 1999, in Brussels, Belgium. Over 300 people attended VICH-1.
The Anthelmintic Working Group has completed four final guidelines (general, bovine, ovine and caprine) and three draft guidelines (equine, swine, canine). The WG also has two future guidelines (feline and poultry) under development. The Quality WG has completed eight final documents and 2 draft documents. The Good Clinical Practice WG has a final document pending sign-off by the Steering Committee. Both the Quality and Good Clinical Practice WGs have essentially completed their work. The Ecotoxicity WG has completed a Phase I document (pending SC sign-off) and expects to complete the Phase II document in 2000. The Safety WG expects to have a draft guideline recommending studies required for the determination of an ADI (Acceptable Daily Intake) of residues of an animal drug in 2000. Additionally, the SC authorized a task force to make recommendations on testing requirements for the determination of ADIs using microbiological endpoints.
As two of the Working Groups have essentially completed their work, the Steering Committee has authorized the formulation of two additional Working Groups: Antimicrobial Resistance and Target Animal Safety. The Antimicrobial Resistance WG, which will be chaired by the EU, will recommend the design of pre-approval studies to assess the rate and extent of resistance development when antimicrobials are used in food-producing animals. The specific scope of work for the Target Animal Safety WG will be defined on the basis of a concept paper to be prepared by Japan.
The Nine-Step Procedure
A nine-step procedure will be followed in developing, implementing, and revising guidelines:
The Steering Committee defines a priority item from a concept paper prepared by a member and appoints a working group if needed. A topic leader is given a mandate to draft a recommendation.
The expert working group drafts a recommendation.
The draft is submitted to the Steering Committee for approving its release for consultation.
Following adoption by the Steering Committee, the draft recommendation is circulated for consultation.
The working group takes comments into consideration in preparing a revised draft. The topic leader must be a representative of a regulatory authority at this stage.
The revised draft recommendation is submitted to the Steering Committee for approval.
A final recommendation and proposed implementation date are circulated to the relevant regulatory authorities.
Steering Committee members report back on the implementation progress in their regions.
Recommendations may be revised at the request of a member to take into account new scientific evidence.