At the end of January, over 240 industry representatives and US and Canadian government food and drug officials met in Washington, DC to review progress and provide direction to working groups dealing with the 29 initiatives included in the US/Canada Regulatory Cooperation Council’s Joint Action Plan. Initiatives on harmonizing regulatory standards for drug master files (DMFs), good distribution practices (GDPs) and over-the-counter (OTC) products were among those receiving attention at the meeting.
In the late January meeting, the discussions in these areas focused on: ● the possibility of creating common drug master file (DMF) systems for excipients, active pharmaceutical ingredients (APIs), and packaging materials; ● the possibility of developing “interchangeable” GMP/GDP standards regarding component controls, supplier qualification and requirements, supply chain controls, and third party auditing qualification for certification; and ● pilots to explore harmonization of the divergent monograph systems in the US and Canada for over-the-counter (OTC) products.
Other discussions in the drug regulatory area centered around: ● the need for common electronic systems for drug product submission and adverse event reporting ● ways to reduce the number of unnecessary/duplicative inspections by increasing mutual reliance on each other’s inspection reports in routine situations, and ● harmonization on terminology for nanotechnology and differing interpretations of particle size significance.
The Canada-United States Regulatory Cooperation Council (RCC) was initiated in January, 2011. Its goal is to increase regulatory harmonization, transparency and coordination between the two countries through a variety of tools – such as enhanced technical collaboration, mutual recognition of standards and joint work sharing – in an effort to address root causes of regulatory misalignments, develop lasting solutions and avoid future misalignments from developing.
The initial joint action plan was undertaken in the areas of agriculture and food, transportation, environment and health and consumer products. The intent was to improve trade flows, lower production costs, streamline regulatory compliance, reduce testing costs, and provide greater consumer choice and a better climate for business and economic growth in both countries while maintaining existing safeguards on the public health.
The next full council meeting is expected to be held in Ottawa, Canada in September 2012.