Posted 12 March 2014
By Alexander Gaffney, RAC
US and international regulators are reportedly working to form a new global regulatory organization focused on leveraging and sharing resources and information among regulatory authorities.
The existence of the organization was announced this week in London by US Food and Drug Administration (FDA) Commissioner Margaret Hamburg, who was attending the Medicines and Healthcare Products Regulatory Agency's (MHRA) ninth Annual Lecture.
"Regulators around the world have begun to collaborate around the formation of an International Coalition of Medical Regulatory Authorities (ICMRA)," Hamburg said, according to a transcript of the event.
Hamburg's speech was largely focused on the global needs of FDA, which she said could be met in part by working more closely with other global regulators to leverage each other's resources.
"We need alternative approaches that rely on enhanced intelligence, information and workload sharing with the help of regulatory partners; data-driven risk analytics; and allocation of resources achieved through public and private partnerships," Hamburg said. "And we need to strive for greater coordination and enforcement of regulatory standards across nations to ensure safety and quality regardless of where a product is produced."
While Hamburg conceded that the same standards will not work for every country, she said regulatory authorities "all need to work together toward the common goals of product safety and quality."
"And truly, this is what most every other national regulator also wants," she continued. "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."
So what will the ICMRA look like? Hamburg said the details of the coalition are still in the early stages and subject to change, but it is envisioned that it will be a "high-level, strategic advocacy and leadership entity."
"It can provide direction for a range of areas and actions that are common to many medical product regulators; identify areas for potential synergies to be made; and, wherever possible, leverage existing efforts to maximize global impact," she mused.
The trick, she added, will be in making sure that all elements are connected into a "coherent and sustainable global system" to support oversight and safety of medicinal products.
The system would also be supported by existing international regulatory coalitions, such as the International Conference on Harmonisation (ICH), the Pharmaceutical Inspection Cooperation Scheme (PIC/S), the International Pharmaceutical Regulators Forum (IPRF), and the Asia Pacific Economic Cooperation's (APEC) Pharmaceutical Product Supply Chain.
"Development of science-based standards and harmonized practices and approaches are an essential underpinning of any strategic direction by regulators," Hamburg said. "And indeed some of these existing mechanisms can be effective operational components and connectors in the implementation of any global coalition's strategic direction."
The coalition has been in the works since at least May 2013, when Brazilian authorities announced its existence in a press release.