Safeguard the quality and safety of traditional Chinese medicine injections

Since last year, after continuously improving the standards for listed Chinese medicine injections, the State Food and Drug Administration has set forth seven technical guiding principles yesterday to make detailed provisions on the quality and safety of Chinese medicine injections.

The seven technical guidelines refer to seven aspects: production process, quality control, non-clinical research, clinical research, risk control, risk benefit evaluation, and risk management plan.

Against the background of the research background, process diversity, and composition complexity of listed Chinese medicine injections, the guiding principle stipulates that Chinese medicine injections should be produced strictly in accordance with the process parameters, process details, and related quality control requirements stipulated in the process regulations, to ensure different batches. The quality of the secondary product is stable and uniform.

The guiding principle states that the ingredients contained in injections should be basically clear. Injectables made from the active ingredients should have a single ingredient content of not less than 90%. Injectables made of multiple ingredients, except for large ingredients, should be determined for content, and individual ingredients should also be determined. For example, an injection containing flavonoids, saponins, alkaloids, etc., need to determine the total flavonoids, total saponins, total alkaloids content, but also need to individually flavonoids, saponins, alkaloids in the content of a single representative test.

The Guiding Principles determine that if there is insufficient and normative clinical safety data support, a systematic non-clinical safety evaluation study of listed Chinese medicine injections should be conducted, including general pharmacological tests, acute toxicity tests, long-term toxicity tests, and preparation safety tests Genetic toxicity tests.

In view of the current status of traditional Chinese medicine injections whose drug instruction manuals are too simple and the guiding principles are clear, manufacturers of TCM injections should improve the contents of the adverse reactions of the instructions, including the timing, conditions and specific performance of adverse reactions, including Severity, type of response, incidence, frequency of occurrence (very common, common, occasional, rare), relationship with medication (affirmative, probable, possible, etc.), clinical symptoms, outcomes, etc. Special attention should be paid to the description of allergic reactions and organ damage.

According to the guiding principles, manufacturers of TCM injections should formulate risk control plans, conduct adverse drug reaction/event collection, report, analysis, evaluation, investigation, emergency response, launch post-marketing research, and minimize risks.