Event Information

Time：October 21, 2014 (Tuesday) 09:30-12:10

Place：TRPMA Conference Room
（1F, No. 465-1, Sec. 6, Zhongxiao E. Rd., Nangang Dist., Taipei City 11557, Taiwan）

The TRPMA and the TGPA jointly organized a BE seminar on Oct. 21 in the light of the government’s policy of expanding export market and the TFDA’s amendment of the guideline on BA and BE studies. The seminar was moderated by Prof Huang Jing-Ding of the Center for Pharmaceutical Science of National Cheng Kung University. Dr Toong-Chow Lee, Chairman of the BE Committee of the ASEAN, was invited to give a speech on the international trend of BE guidelines. Dr Hsu Li-Fong, a senior reviewer of the CDE, briefed the audience on the amendment of the BE guideline in Taiwan. Prof Hsu Kuang-Yang and Prof Pao Li-Heng, experts in Pharmacokinetics, also attended the seminar to enrich the discussion.

Dr Hsu Li-Fong, a senior reviewer of the CDE, introduced the BE guideline and regulations in Taiwan. From a reviewer’s viewpoint, he shared his experiences in reviewing BE cases. Dr Hsu gave a detailed explanation of the draft amendment of the BE guideline announced by the MOHW on Aug 27, 2014. He also compared it with the regulations in the US, the EU and the WHO to help the audience understand that the purpose of the amendment is to bring the regulations into line with international practices.

Dr Toong-Chow Lee, Chairman of the BE Committee of the ASEAN, introduced the current BE regulations in the south-east Asian countries and the development of related guidelines. Dr Lee said that the BE regulations and guidelines are basically based on the EU regulations with variations to meet individual country’s needs. He also mentioned that the BE requirement varies from country to country in the ASEAN. Drug companies intending to export their products to ASEAN member countries have to take individual country’s demands into account. In fact, how to harmonize the regulations among the ASEAN member countries is one of the challenges faced by the organization.

At the end of the seminar, the moderator, two speakers and Prof Hsu Kuang-Yang and Prof Pao Li-Heng chaired the panel discussion, talking about the problems concerning the selection of reference drugs for generics in Taiwan and Malaysia and possible solutions, the purposes of the amendment of the BE guideline in Taiwan, and the hope that by bringing the regulations into line with international practices, the government can help drug manufacturers in Taiwan to enter the global market.

The TRPMA and the TGPA jointly organized a BE seminar on Oct. 21