Setting the Scene  

There is an African proverb: if you want to go fast, go alone. If you want to go far, go together. Thus began the opening words from Alice Sigobodhla, Head of Veterinary Medicines Unit, South African Health Products Regulatory Authority, as she opened an inspiring session on “Opportunities from international guidelines and regional collaborations” at the 7th VICH Conference “VICH and a new era.” 

In fact, the warm and collegial tone of the conference was set from the very first session, as Javier Yugueros-Marcos, Head of Department, Antimicrobial Resistance and Veterinary Products Department at WOAH, introduced the keynote speakers to the conference participants. He commented “This conference brings together a group of people who want to create harmony in this world”.  

The nearly 200 conference participants seeking harmony had travelled to Amsterdam from 26 countries, from as far away as New Zealand, Australia, India, Brazil, Chile, Korea, and Japan, and from as near as the Netherlands, Belgium, Germany, France and UK. They were roughly split between one third regulatory authorities and two-thirds industry (regulatory affairs professionals from, or servicing, manufacturers of veterinary medicinal products).  

A Little Bit About VICH  

Before exploring more about the conference, perhaps first a few words about VICH, for those not familiar with the project. VICH was officially launched in April 1996 at the instigation of the World Organisation for Animal Health (WOAH, formerly known as OIE), with Founding Members of the European Union, the USA and Japan. New Zealand, Australia, and Canada came on-board as Standing Members (which participate but do not have a say in final decisions), and were later joined by South Africa and UK. Other countries, fulfilling a set of criteria, can apply to the VICH Steering Committee (SC) to become silent observers at the annual SC meetings. 

The two first objectives of the VICH project are:  

• Establish and implement harmonised technical requirements for the registration of veterinary medicinal products in the VICH regions, which meet high quality, safety and efficacy standards and minimise the use of test animals and costs of product development.  

• Provide a basis for wider international harmonisation of registration requirements.  

VICH works by the SC reviewing ‘concept papers’ proposing the creation or revision of a VICH guideline, and if approved, an expert working group (EWG) on that topic is created. A stipulation of the VICH process is that the EWGs, just like in the steering committee, must contain a balance of experts from both the regulatory authorities and the industry from the VICH countries or regions. All decisions (in SC and the EWGs) are made by consensus. There are currently 9 EWGs working on new guidelines or on updating existing ones.