The 6th Joint Conference of Taiwan and Japan on Medical Products Regulation in Japan

  • Resource: TFDA
  • Release date: 10/12/2018 3:05:24 PM

The 6th Joint Conference of Taiwan and Japan on Medical ProductsRegulation is taking place on the 11th October 2018 at Tokyo Japan.This year the representatives from TFDA, Centre for Drug Evaluation(CDE), National Health Insurance Administration (NHIA), medicinalproducts and medical devices industrial associations will visit Japanand share the latest information about the pharmaceutical regulations,the managements of the real world date and how is it applied to thepharmaceutical regulations, policies that promote OTC drugs and theadjustments of the NHI reimbursements with the representatives fromJapan’s regulatory authorities and industries. Through thisopportunity, we hope that the mutual understandings of the regulatoryinformation from both countries can be reached, and the collaborationsbetween regulatory authorise and industries from both countries can beenhanced. We look forward to increasing the regulatory reviewstandards, helping the industries to have the advantage of enteringinternational markets, as well as securing the public health.

“The Joint Conference of Taiwan and Japan on Medical ProductsRegulation” is one of the communication platforms under the “Frameworkof the Cooperation on the Medical Products Regulation,” which wassigned by “Taiwan-Japan Relations Association” and “Japan-TaiwanExchange Association” on November 2013. Taiwan Food and DrugAdmistration (TFDA) and Japan Ministry of Health, Labour and Welfare(MHLW) / Pharmaceuticals and Medical Devices Agency (PMDA) have formedseveral working groups, through which Taiwan and Japan have beencommunicating and exchanging information about pharmaceutical policiesand regulations regularly. Taiwan and Japan have also co-organisedannual conferences alternatively. This year is the sixth year of thecollaborations.

Under the framework, the working groups included activities such astwo-sided official visits and observations, as well as discussions andcomparisons of some of the highly interested topics in new drugregulations and review standards. Taiwan and Japan also co-organised aworkshop on the 8th May this year to share regulatory updates forbioequivalence studies. In addition, Taiwan and Japan is currentlyconstructing a novel co-review mechanism and on the preparation ofsigning MOC for the Medical Devices as well. TFDA looks forward toshortening the review times for medicinal products and medical devicesand helping Taiwan industries to prosper.