Updated on 26 September 2012
Regulatory strategy for new drug application
Standard review is regular review of non-CPP (Certificate of Pharmaceutical Product) application, good clinical practice, good laboratory practice, risk evaluation and mitigation strategies, good manufacturing practice and risk management plans. Moreover, priority review is for new chemical entities, serious diseases and unmet medical needs.
Furthermore, Innovative product review is for new indications, combinations, route of administrations, dosage forms, unit doses and new chemical entities. It also includes domestically manufactured products, drugs that fulfil Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) criteria and GMP regulation.
Regulatory consultation system for pharmaceutical products in Taiwan can be done through online information, consultation by request, active consultation and industrial communication platform.
The Taiwan FDA is looking at enhancing review quality, efficiency and transparency and strengthening standards of reviewers. It needs to improve regulation consultation mechanism to facilitate industrial development and increase international competitiveness. And promote international, regional and cross-strait drug regulatory harmonization and cooperation.
(As shared by Hui-Ping Chang, section chief, Division of Drugs and New Biotechnology Products, Taiwan Food and Drug Administration, during 'Pharmaceutical Regulatory Summit' held in Singapore during August 2012)
To know more about regulatory-related issues in Taiwan, visit www.doh.gov.tw