REGULATORY INFORMATION TRANSFER IS NEW TOPIC FOR INTERNATIONAL CONFERENCE ON HARMONIZATION; SEVEN TRIPARTITE GUIDELINES FINALIZED BY ICH STEERING CMTE.
Executive Summary
Regulatory information technology is a new topic to include in the international drug review and approval harmonization process following an affirmative vote on the topic by the International Conference on Harmonization Steering Committee at an Oct. 26-27 meeting in Brussels, Belgium.