Specialist Fields

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Market Entry Support: China

Regulatory Affairs Support

Our reliable network of China experts provides comprehensive support for companies entering China’s market for pharmaceuticals and medical devices, both in terms of the information required and knowledge of the business procedures involved. Thanks to this network, we are able to gather and provide accurate information in a timely manner, have local experts perform regulatory affairs research, and leverage the local expertise of China’s top CRO. These capabilities enable us to provide support in the following areas:
  • CFDA regulatory affairs representation for both pharmaceuticals and medical devices
  • Consultations on good regulatory practice
  • Preparation of regulatory dossiers
  • Generating greater exposure for our customers by increasing their profile in publications and at events (conferences, symposiums, etc.)
  • Support for clinical trials in China

 SunFlare's support network for entry into the Chinese market

What is the China Pharmaceutical Technology Transfer Center?

The China Pharmaceutical Technology Transfer Center was established in 1997, in accordance with the Chinese government’s policy of establishing systems for the creation and transfer of technologies and of reorganizing its scientific, technological, and economic systems. It specializes in the provision of consulting services for the transfer of pharmaceutical technologies. The Center operates under the supervision of China’s Ministry of Public Health (equivalent to Japan’s Ministry of Health, Labour and Welfare) and its Ministry of Science and Technology (equivalent to Japan’s Ministry of Education, Culture, Sports, Science and Technology). Its principal mission is to introduce overseas technologies to China and open up research conducted in China to Chinese companies.

What kind of people make up SunFlare’s network of China experts?

SunFlare’s network of China experts is made up of experts in a variety of fields related to medical care and medical devices, including members of the CFDA Drug Evaluation Committee.