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Based on the new changes in the definition of falsified and substandard drugs and the new requirements for their identification in newly revised "Drug Administration Law" and "Interpretation for Handling the Criminal Cases Endangering Drug Safety", this paper discusses a new working mode for the detection of falsified and substandard drugs. In the new working model, the detection of falsified and substandard drugs can be classified into two kinds: to need and not to need the support of testing results. If testing is needed, three factors should be considered, i.e., the implementer of testing, testing capability, and presentation of testing result. The paper cited two typical examples taking place respectively in 2006 and 2015 to elaborate how testing result supported the detection of falsified and substandard drugs, one is about illegally adding diglycol in injection, another is about adulterated Ginkgo biloba leaves and their extracts. In order to improve the quality and efficiency of the detection of falsified and substandard drugs and optimize the utilization of drug testing resources, the testing of falsified and substandard drugs under the new requirements should be based on the needs of the identification, with the goal of supporting the drug regulatory department to issue the identification opinion about the falsified and substandard drugs. The model will change the traditional understanding on the role of drug testing results in supporting the confirmation of falsified and substandard drugs, to delink the connection between detection and testing, making the testing result not the precondition for the confirmation of falsified and substandard drugs. In order to implement the new work mode, drug regulatory authorities at prefecture level and above need to clarify the identification of whether inspection support is needed according to the laws, national and provincial drug inspection institutions need to establish a division of labor and cooperation mechanism that matches the regulatory functions, and drug testing institutions need to clarify the requirements for samples, standards for testing, and testing conclusion.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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