The Global Harmonisation Task Force

The Global Harmonisation Task Force (GHTF) was conceived in 1992 to address similar issues for medical devices. It has a broader regional base than its pharmaceutical counterparts in that it includes representatives from Canada and Australia in its core group, in addition to those from the EU, US and Japan. In some ways, it also faces a stiffer challenge in that there is more divergence in the regulatory 

The Steering Committee defines a priority item from a concept paper prepared by a member and appoints a working group if needed. A topic ieader is given a mandate to draft a recommendation. 

The draft is submitted to the Steering Committee for approval of its release for consulfation. 

Following adoption by the Steering Committee, the draft recommendation is circulated for consultation. 

The working group takes comments into consideration in preparing a revised draft. The topic leader must be a representative of a regulatory authority at this stage. 

---