Event Information

Time：December 29, 2014 (Monday)

Place：GIS Taipei Tech Convention Center

In the meeting on the cross-strait drug registration regulations and technical support, Dr. Tien-Tzu Tai, a specialist of the CDE, introduced the impact of the cross-strait drug registration regulations on the planning of new drug R&D. Dr. Tai explained the regulations and analysed the management of clinical trials on new drugs and administrative procedures in Taiwan and China. He also highlighted the differences in the requirements on technical dossiers. Dr. Tai also introduced the current drug review practices in China and pinpointed the challenges and hurdles faced by the biotech manufacturers in Taiwan. Please refer to the attachments for Dr. Tai’s presentation materials.

Ms. Chia-Ling Hsiao, a section chief of the CDE, briefed the audience on the BE guidance on generics and the principles of reviewing generics with special dosage forms. She also analysed the differences in Taiwan and China. Please refer to the attachments for Ms. Hsiao’s presentation materials. The TRPMA members are highly interested in the cross-strait issues. The Secretariat is to organize a seminar and invite the Executive Director of the CDE and the officers in charge of cross-strait affairs to give speeches. Details are to be announced.