The Next Phase of the Global Harmonisation Task Force (GHTF) Evolution…

Recently there has been significant discussion on the future direction of the GHTF. In a statement released on March 28 2011, Larry Kelly, the chair of the GHTF,  confirmed that the current GHTF structure will morph into a Regulator’s Group. This was considered the best way to continue to work towards the objective of harmonised regulatory requirements by GHTF senior officials.

The GHTF was conceived in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems. A partnership between regulatory authorities and regulated industry, the GHTF is currently comprised of five Founding Members: the EU, the US, Canada, Australia and Japan.

The update from Larry Kerry indicates senior officials from all GHTF device regulatory authorities believed the work on the GHTF regulatory model was substantially complete. It was also noted the high degree of influence the GHTF model has had, and continues to have, on developing countries/economies with developing need for regulation of medical devices.

Mr. Kelly stated that within the new structure, input and advice from industry would continue to be vital, adding that the new forum will allow for input from other stakeholders such as healthcare professional groups, academia, and consumers. The new group will allow for more detailed discussion from members on the optimum ways to achieve harmonisation at an operational level. The next phase of GHTF evolution will be based on the GHTF regulatory model and supporting documentation with a focus on harmonisation at the operations level.

The GHTF provides valuable resources for medical device manufacturers, and it is hoped harmonisation of regulatory requirements will progress in whatever form the group takes. The GHTF meet again in May 2011….stay tuned for updates.

To read Larry Kelly’s statement, click here.