Taiwan FDA Issues eCTD Specifications and Validation Criterion

In order to promote Taiwan’s adoption of ICH Electronic Common Technical Document (eCTD) format of , applicants will be able …

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Taiwan’s Guidance on Registration of Artificial Intelligent / Machine Learning-Based Software as a Medical Device (AI/ML-Based SaMD)

The Taiwan Food and Drug Administration has released a guideline pertaining to the application of artificial intelligence related to medical …

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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 …

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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) …

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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 …

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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 …

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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 …

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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 …

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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 ( …

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