Taiwan FDA has Amended the Regulations for Good Clinical Practice in Consideration of ICH E6(R2)

The changes are with the consideration of the ICH E6(R2), key changes are: Article 23: sponsor’s subsidies and payments provided …

read more...

Taiwan Implements GMP/GDP for API Manufacturers

Taiwan FDA has announced that API manufacturers must 1) from 27 July 2020, API manufacturers (including those only for export) …

read more...

Taiwan Publishes a Separate Standards of Review Fees for the Registration of Western Medicines

Standards or Review Fees for the Registration of Western Medicines Considering the increase in complexity and novelty of the western …

read more...

Taiwan Guideline for Basic Considerations for Real World Evidence for Drug Development

The use of Real-world Data (RWD) to produce appropriate Real-world Evidence (RWE) as a basis or supplement for drug efficacy …

read more...

Taiwan Issues Guidance on In-Vitro Companion Diagnostic Devices (CDx)

The Taiwan FDA issues on 16 July 2020 the guidance on in-vitro companion diagnostic devices (CDx), which are aimed to …

read more...

Taiwan to Conduct GCP Inspection in Compliance with New Drug Applications

Taiwan Food and Drug Administration (FDA) published a guideline on 28 May 2020 to improve the efficiency of new drug …

read more...

Taiwan Intends to Implement Inspection scheme for Bioequivalence Trial ( in 2021)

Towards an aim to ensure the quality and data management of bioequivalence study, the Taiwan Food and Drug Administration ( …

read more...

More News