Step 5 Implementation

Having reached step 4 the tripartite harmonized text moves immediately into the final step of the process, which is regulatory implementation. This is carried out according to the same national/regional procedures that apply to other regulatory guidelines and requirements in the European Union, Japan, and the United States. Information on the regulatory action taken and implementation dates are reported back to the Steering Committee and published by the Secretariat.

Whether preventing unnecessary duplication of clinical trials and minimizing the use of animal testing, without compromising the regulatory obligations of safety and effectiveness, will be cost effective through expeditious development of pharmaceuticals with consistent quality, safety, and effectiveness remains to be seen. Nevertheless, a uniform regulatory system that permits the same information to be assembled in documents for different regulatory agencies, thereby avoiding the need to submit redundant preclinical and clinical information, manufacturing, and packaging, can translate into huge cost savings in developing pharmaceuticals to be marketed globally.

0 0

Post a comment