Understanding the Current Regulatory Landscape for Companion Diagnostic Products in China

Xu, Xiaolei; Li, Jinbo; An, Juanjuan

doi:10.1016/b978-0-12-813539-6.00018-3

Cited by 2 publications

(5 citation statements)

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“…The U.S., E.U., and Japan are the largest markets for IVDs, respectively. 67 More recently, other markets have emerged, such as China, which has become of great interest due to the rapid growth in its oncology market. 67 Australia’s IVD market remains very small, accounting for approximately 1.35% of global IVD sales, however, imports of IVDs make up 95% of the Australian market, the majority of which are from the U.S. and E.U.…”

Section: Other Regulatory Considerations: Japan China Australia and Who’s Ivd Prequalification Programmentioning

confidence: 99%

“…The Chinese regulatory authority, the National Medical Products Administration (NMPA), has not yet published any guidance for CDx. 67 However, as CDx are classified as class III IVD products they follow IVD regulations, which stipulate that applications are to be supported by clinical trials conducted in China. 67 Currently, the regulatory assessment process for CDx is challenging, due to different regulations and independent review centers for IVDs and therapeutics, with limited interaction/collaboration between the two.…”

Section: Other Regulatory Considerations: Japan China Australia and Who’s Ivd Prequalification Programmentioning

confidence: 99%

“… 67 However, as CDx are classified as class III IVD products they follow IVD regulations, which stipulate that applications are to be supported by clinical trials conducted in China. 67 Currently, the regulatory assessment process for CDx is challenging, due to different regulations and independent review centers for IVDs and therapeutics, with limited interaction/collaboration between the two. However, in 2017 new procedures for approval were proposed to facilitate the development/approval of IVDs, including CDx.…”

Section: Other Regulatory Considerations: Japan China Australia and Who’s Ivd Prequalification Programmentioning

confidence: 99%

“…However, in 2017 new procedures for approval were proposed to facilitate the development/approval of IVDs, including CDx. For instance, the NMPA may now accept clinical data from global trials outside of China (for other proposed changes see Xu et al 67 ).…”

Section: Other Regulatory Considerations: Japan China Australia and Who’s Ivd Prequalification Programmentioning

confidence: 99%

“…67 More recently, other markets have emerged, such as China, which has become of great interest due to the rapid growth in its oncology market. 67 Australia's IVD market remains very small, accounting for approximately 1.35% of global IVD sales, however, imports of IVDs make up 95% of the Australian market, the majority of which are from the U.S. and E.U. 68 Japan, China, and Australia have their regulatory authorities that assess IVD applications, including CDx (see Table 6 for an overview).…”

Section: Australia and Who's Ivd Prequalification Programmentioning

confidence: 99%

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Companion Diagnostics: State of the Art and New Regulations

et al. 2021

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Companion diagnostics (CDx) hail promise of improving the drug development process and precision medicine. However, there are various challenges involved in the clinical development and regulation of CDx, which are considered high-risk in vitro diagnostic medical devices given the role they play in therapeutic decision-making and the complications they may introduce with respect to their sensitivity and specificity. The European Union (E.U.) is currently in the process of bringing into effect in vitro Diagnostic Medical Devices Regulation (IVDR). The new Regulation is introducing a wide range of stringent requirements for scientific validity, analytical and clinical performance, as well as on post-market surveillance activities throughout the lifetime of in vitro diagnostics (IVD). Compliance with General Safety and Performance Requirements (GSPRs) adopts a risk-based approach, which is also the case for the new classification system. This changing regulatory framework has an impact on all stakeholders involved in the IVD Industry, including Authorized Representatives, Distributors, Importers, Notified Bodies, and Reference Laboratories and is expected to have a significant effect on the development of new CDx.

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Section: Other Regulatory Considerations: Japan China Australia and Who’s Ivd Prequalification Programmentioning

confidence: 99%

Section: Other Regulatory Considerations: Japan China Australia and Who’s Ivd Prequalification Programmentioning

confidence: 99%