On May 24, 2016, The European Commission published a proposal for an annex to the Transatlantic Trade and Investment Partnership ("TTIP") on medicinal products together with a Report of the 13th Round of Negotiations for the TTIP. The proposal describes the conditions under which each competent authority makes decisions on marketing authorizations, promotes international harmonization, and establishes frameworks for the mutual recognition of Good Manufacturing Practice ("GMP") inspections, for the exchange of confidential information including trade secrets and for bilateral regulatory cooperation. Discussions on the proposal will continue at the next round of negotiations.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
