CFDA applying ICH technical guidelines to drug filings, safety management

CFDA’s follow up on full ICH membership

Having become a full member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) in June last year, the CFDA is quickly moving to apply various ICH guidelines to serve as the basis for drug reviews and approvals. As part of reforms designed to accelerate the handling of innovative drugs, five of the ICH’s Tier 2 guidelines will be adopted in stages. From February 1, 2018, the ICH M4 “Common Technical Document” for the registration of pharmaceutical products will be applied to all chemical drug Category 1 and 5.1, and both therapeutic and preventive biologics category 1 filings.

The CFDA will also require that clinical trial safety data and reports are carried out according to ICH standards from May 1 this year, while the Council’s standards for post-marketing adverse events reporting will be applied from July 1, 2018. In a separate announcement, the CFDA released technical guidelines for filings related to innovative drugs at the Phase I clinical trial stage, as the agency pushes on with plans to raise drug regulation up to international standards and drive the development of an innovative local industry. To achieve these goals, the CFDA has released a blizzard of reform policies over the last 2 years.

Source: GBI (

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