China regulates clinical use of innovative oncology drugs, requires biomarker testing
Minhua Chu ·01/06/2022

At the end of 2021, China’s National Health Commission (NHC) updated its guidelines for the clinical application of innovative oncology drugs. The new guidelines stipulate that the use of oncology drugs requires a pathological diagnosis, and these drugs cannot be used arbitrarily beyond indications in the inserts. The guidelines clarify that some drugs need biomarker testing before prescriptions and listed specific biomarker requirements and recommendations for each drug.

The 2021 guidelines were based on the 2020 iteration, with some modifications and improvements. This new version added five new tumor types: pleural mesothelial cancer, uroepithelial cancer, prostate cancer, naïve and recurrent ovarian cancer. New drugs and indications approved this year were also included.

The guidelines stipulate that only malignant tumors confirmed by histological, cytological pathology, or special molecular pathology diagnosis, are indications of anti-tumor drugs, except for patients who are not suitable for surgery or biopsy after multidisciplinary consultation. 

Confirmatory tests for tumors that evade pathological diagnosis, such as pancreatic cancer and gestational trophoblastic tumors, can be performed in accordance with relevant national guidelines.

Innovative anti-tumor drugs, including small molecule targeted drugs and large molecule monoclonal antibodies, can be put into two categories according to whether biomarker testing is required, and which biomarkers needed to be tested are given.


“The clinical use of anti-tumor drugs must follow the drug inserts and cannot be used arbitrarily beyond the indications,” the guidelines said. The right of off-label prescriptions under special circumstances should be limited to chief physicians and associate chief physicians of tier-three hospitals, which represent the best hospitals in China.

Special cases in which physicians can prescibe anti-tumor drugs in off-label indications based on evidence-based medicine include indications in inserts from other countries or regions, treatment guidelines issued by international organizations, and the clincial guidelines and pathways issued by national organizations in China and recognized by the NHC.

The guidelines also suggest giving preference to drugs with superior pharmacoeconomic evaluation results and require hospitals to promptly report serious and newly discovered adverse reactions.

Standardizing the clinical use of oncology drugs

In the past two years, several documents have been issued  in China to standardize the clinical use of anti-tumor drugs. Developers must now meet higher requirements than ever.

In December 2020, the NHC issued a document to implement a grading system for oncology drugs and launch a national clinical application monitoring network.

On June 28, 2021, the NHC issued The Management Indicators for the Rational Clinical Application of Oncology Drugs, which identifies six indicators that classify oncology drugs into two categories: restricted-use grade and general-use grade.

On Novermber 19, 2021, the CDE published  guidelines for value-oriented clinical trials of oncology drugs. This summarized how regulators review and approve oncology drugs based on their clinical value.

With these regulations, the use of anti-tumor drugs is expected to become more standardized. Drugmakers should therefore consider clinical value and use during R&D to obtain the market.

Keywords: biomarker testing prescriptions specific biomarker requirements recommendations new guidelines clarify
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