On 6 March 2014, the US Food and Drug Administration (FDA) Commissioner Margaret Hamburg addressed attendees of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) Annual Lecture 2014 and announced that steps are underway to form a new international coalition: the International Coalition of Medicines Regulatory Authorities (ICMRA). FDA Commissioner Margaret Hamburg described how "what we really need for the future is a public health safety net for consumers around the world that is created, supported, and maintained by a global alliance of regulators."
It is understood that, so far, 20 Heads of medicine and regulatory authorities are engaged in the ICMRA, including those from authorities in the US, from member states of the EU, and from China, South Korea and Brazil. Authorities from India are yet to be engaged.
Formalising ICMRA will continue through 2014 and there is hope that the full coalition will be close by the 9th International Summit of Heads of Medicines Regulatory Agencies in autumn 2014 in China.
Coalition aims would include:
- analysing the work of existing pharmaceutical product supply chain initiatives and collaborations;
- sharing information and best practices in supply chain safety;
- establishing common regulatory standards for pharmaceuticals;
- co-operating in the surveillance of supply chains;
- helping developing countries build regulatory capacity; and
- addressing co-ordination and leadership to strengthen the integrity of the supply chain.
The ICMRA will tackle the globalised threat of health incidents arising from medical product contamination and counterfeiting. The drawing together of the ICMRA further reflects the trend of growing international cooperation between regulatory authorities.
Note for Companies: It has long been the case that regulatory authorities have worked together on particular product issues. As a result of this initiative, it we are likely to see an even more coordinated approach, which should be taken into account when responding to regulatory authorities, particularly where issues of safety arise.
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