Taipei, March 1, 2007: The annual Strategic Review Board (SRB) meeting of the Taiwan’s Science and Technology Advisory Board has pledged to revamp regulations governing the registration of new drugs.

 

To match Taiwan's drug approval process with international norms, the advisory body has decided that the time and process steps reviewed by the Department of Health for a New Drug Application (NDA) will be reduced. This decision is one among the new policy changes that are intended to make Taiwan a more attractive research and operations destination for international pharmaceutical and biotechnology companies.

 

According to industry watchers, Taiwan's NDA procedure involves too many steps and decision-making bodies, and is too opaque. The new changes in the policy aim to correct this by doing away with the current second-step investigation and approval by the Department of Health’s Drug Review Board – a step considered somewhat redundant – with the new process handing the responsibility of the NDA approval process entirely over to the non-governmental Center for Drug Evaluation (CDE). The Drug Review Board will in turn become a consulting organization. This change could see the time required to receive NDA consent to drop from the current six months to around 30 days only.

 

To support Taiwan's generic drug industry, DOH has also decided to take measures to simplify the NDA application time. In addition, tax benefits and other incentives for establishment of pharmaceutical-related R&D centers by overseas companies will be revamped. To attract investment funds into early-stage biotech companies, the maximum limit on technical shares held in a company will also be loosened.