China adopts ICH guidelines and collaborates with UK

Generics and biosimilars Initiative

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China adopts ICH guidelines and collaborates with UK

INICIO/Directrices | Posted 23/02/2018 0 Post your comment

As of 1 February 2018, the China Food and Drug Administration (CFDA) will be adopting five safety and regulatory guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). China became the eighth member of ICH in June 2017, which marked a significant expansion of ICH’s impact and aim to promote global public health.

In addition, the CFDA signed a memorandum of understanding on drug regulation, with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), in February 2018. This focuses on the sharing of information from accelerated access reviews and developing effective ways to regulate online medicine trading. In a statement, the MHRA noted that close collaboration with China, a global leader in pharmaceuticals raw materials supply, will promote innovation and good practice and be of benefit to UK patients.

These announcements come soon after the CFDA’s January 2018 announcement that it had issued draft guidance on the public disclosure of information related to its review and approval of drug applications. This marked a form of transparency not seen before in China [1].

The five ICH safety and regulatory guidelines to be adopted by the CFDA include the adoption of: a common technical document for submissions for certain therapeutics; the ICH guidelines for expedited reporting of clinical safety data before and after a drug’s approval; and guidelines for individual case safety reports. In addition, the CFDA will use the council's Medical Dictionary for Regulatory Activities (MedDRA). The CFDA hopes that these guidelines will facilitate reforming its review and approval system and encourage the development of innovative drugs and devices.

ICH has a mission to help increase patient access to safe, effective and high quality pharmaceuticals, and ensure that pharmaceuticals are developed and registered efficiently. It was initially established in 1990, to facilitate international collaboration between regulatory agencies and industry associations from Europe, Japan and the US. Since then, it has been successful in standardizing and elevating drug development practices globally.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. China FDA issues draft guidance on drug review and approval transparency [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 23]. Available from: www.gabionline.net/Guidelines/China-FDA-issues-draft-guidance-on-drug-review-and-approval-transparency

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Source: MHRA, US FDA