Pharmabiz
 

Mexico-Canada-US pact to promote drugs and devices

Our Bureau, MumbaiThursday, June 15, 2006, 08:00 Hrs  [IST]

Mexico, Canada and US has entered into a trilateral cooperation to increase communication, collaboration, and the exchange of information among the three countries in the areas of drugs, biologics, medical devices, food safety and nutrition to protect and promote human health. Member agencies work together toward a common mission to protect and promote public health through a trilateral forum that shares information and works collaboratively on issues of mutual interest. Members of the trilateral co-operation include the Health Products and Food Branch (HPFB), Canadian Food Inspection Agency (CFIA), and the Competition Bureau of Canada, the United States Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) of USA and the Federal Commission for the Protection from Sanitary Risks (COFEPRIS), and the Federal Office of the Judge Advocate General of Consumers (PROFECO) of Mexico. The trilateral cooperation is building a trusted compliance information network by building confidence between three countries on their regulatory processes and decision-making practices. Through continual discussions, the member agencies share information and explore areas of mutual interest on the continuum of compliance with each countries' respective statutory authorities. The agencies involved in this area of cooperation include the Health Product and Food Branch of Health Canada, and Canadian Food Inspection Agency, COFEPRIS of Mexico and the US FDA. The Co-operation Charter, signed in February 2004 and reassessed in October 2005, recognizes that others may be invited to participate (based on the issues before the trilateral co-operation). The strategic objectives of the treaty includes identifying and solving problems; Sharing information and best practices, and establishing harmonized positions on issues of mutual interest; identifying emerging issues of common interest; promoting capacity building; developing confidence/capacity and trust among members of the trilateral; increasing public confidence; developing partnerships; and developing mechanisms for cooperation and working collaboratively to implement solutions for issues of mutual interest. To achieve these objectives, the parties to the trilateral cooperation is guided by a focus on health and safety issues; the advancement of public health; equal participation for all stakeholders; serving the interests of all three countries; and the use of joint problem-solving techniques and consensual decision-making processes. The trilateral heads of delegation team is the decision-making body of the trilateral cooperation. It comprises the leaders of HPFB (Assistant Deputy Minister), the FDA (Commissioner of Food and Drugs), and COFEPRIS (Federal Commissioner). Reporting to the heads of delegation, the steering committee sets the agenda for each meeting in line with the principles and strategic objectives, focusing on priorities that benefit all countries. The committee provides leadership to the working groups and recommends high-level policy issues to the heads of delegation. As well, it identifies and discusses new and emerging issues confronting the three countries. The steering committee consists of an equal number of members from each country, with the selection being the responsibility of the individual countries. The steering committee is led by country co-chairs who serve as liaisons to the working groups. The trilateral cooperation undertakes its work through working groups. Currently, the trilateral cooperation has five working groups: Canada-US-Mexico Compliance Information Working Group (CUMCIG): Its purpose is to share information and explore areas of mutual interest on the continuum of compliance decision-making approaches. Emergency Preparedness and Response (EPR) Working Group: Its purpose is to enhance the ability to respond to emergencies related to foods, drugs, medical devices, biologics and veterinary products that may affect more than one participating country. Laboratory Cooperation Working Group: Its purpose is to establish and maintain cooperation in the area of regulatory laboratory operations. Through continual discussions, this group is expected to share information with a view to building confidence in our respective analytical results. Mexico-US-Canada Health Fraud (MUCH) Working Group: Its purpose is to maintain a formal framework for cooperation in combating health fraud and to identify appropriate lines of communication to ensure a continual exchange of information on compliance and enforcement activities among the three countries. Training Working Group: Its purpose is to share existing training information, establish a communication strategy between the Training Working Group and the other Working Groups, and to assist in identifying training needs of staff who will be engaged in Trilateral work. Each country shall identify a lead representative and an alternate representative for each of the working groups. Each country will be assigned the responsibility of leading the work of specific working groups based on the following three-year rotation scheduled established by the Steering Committee in 2005. The responsibilities of leading a working group shall include:chairing the teleconferences/meetings; providing secretariat support to their assigned working groups.

 
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