Trade ministers of Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, United States, and Vietnam have finally agreed to ink a Trans-Pacific Partnership (TPP) agreement after more than five years of conversation. The TPP would probably be the largest free trade agreement worldwide since these 12 nations comprise around 40 percent of the global GDP. The pact would affect companies of all sectors of the global economy, including pharmaceuticals, medical devices, financial services, technology and telecommunications firms, etc. The key provisions for pharmaceuticals and medical devices trade include tariff phase-outs to facilitate business and assurance that TPP Parties’ domestic measures would not put unnecessary restraints to business. This will also lead to better transparency level, improved regulatory cooperation and good practices. The medical devices annex of the agreement provides important information about basic procedure for market authentication including timelines, neutrality, and appeal/review procedures for adverse decisions. Parties are agreeing that it is not necessary that a device requires approval in the country of manufacturing for marketing authorization elsewhere. According to the annex, parties need to classify medical devices based on risk. Safety & efficacy performance, design, and manufacturing quality, labeling information and any other factor that affects medical device user health or safety are the important pre-requisites in order to authorize marketing of devices. Marketing of a product would not require any kind of sale, pricing, or related financial data.
