MHRA在其博客中提到PDE值计算指南只是对于“高有害”物质才是有必要的：
Now, the MHRA states that the full use of EMA's guide for the calculation of the PDE values is only necessary for so-called 'highly hazardous' products. To answer the question whether a product is highly hazardous or not, one can refer to the new Q&A document of the EMA. Nevertheless, one should keep in mind that the assessment of hazard by means of EMA's paper, scientific data are also required which would also enable the calculation of the PDE limits.
现在MHRA说全面应用EMA关于PDE值计算指南只是对于“高有害”物质才是有必要的。为了解答一个产品是否高有害性，大家可以参照新的EMA问答文件。不论如何，大家要谨记，根据EMA文中方法进行的危害分析也需要科学数据，用这些数据也可以计算PDE限度。
However, Health Based Exposure Limits (HBELs) should be determined for all products. If a product is classified as not 'highly hazardous', the 1/1,000 dose criterion can still be used.
但是，应该计算所有产品的基于健康的暴露限（HBEL）。如果有一个产品被分类为非“高危害”产品，则仍可以使用1/1000剂量标准。
那么什么样的产品被认定为高有害产品呢，EMA在一份问答中给出了答案：
A: Highly hazardous products are those that can cause serious adverse effects at low doses and that therefore would benefit from a full toxicological assessment in order to derive a safe HBEL.
高有害物质是指低剂量即可能导致严重不良反应，因而需要进行全面毒性评估以制订安全的HBEL的物质。
Highly hazardous products are identified based on their inherent toxicological and pharmacological characteristics and include the groups below (this list is not an exhaustive list and if evidence is available indicating that the product may cause adverse effects at low doses by other mechanisms it should be considered as highly hazardous).
高有害物质应根据其内在毒性和药学特性进行识别，并分为以下几类（此清单并不包含所有情况，如果有证据显示该产品可能因其它机制由低剂量即导致不良反应，则也应作为高有害物质考虑）。
Manufacturers should consider, via a safety assessment against the guidance below, if products/active substances should be considered highly hazardous. Evidence indicating a product or active substance falls within any of the categories below should result in a product being considered highly hazardous. If in doubt, manufacturers should consider the product potentially highly hazardous and apply the EMA guide (EMA/CHMP/CVMP/SWP/169430/2012) in full to derive a safe HBEL.
如果药品/活性物质应作为高有害物质，则生产商应根据以下指南进行安全评估。显示一种药品或活性物质属于以下某个类别的证据应能证明一种药品作为高有害物质来考虑。如果有疑问，则生产商应将该物质作为潜在高有害物质考虑，并全面应用EMA指南（EMA/CHMP/CVMP/SWP/169430/2012）来建立安全HBEL。
1. Genotoxic (specifically mutagenic) compounds that are known to be, or highly likely to be, carcinogenic to humans. Compounds of this group are easily identifiable, since genotoxicity would be related to the pharmacology, e.g. as DNA alkylating cytostatics, and their use is usually restricted to oncology indications with respective warning statements in the Summary of Product Characteristics.
基因毒性（尤其是基因诱变）化合物一般是，或者非常可能是，对人类致癌的。此类化合物一般易于识别，因为基因毒性一般与药学相关，例如，是DNA烷基化细胞抑制剂，它们的使用一般局限于肿瘤症状，在产品特性摘要上有相关的警示声明。
2. Compounds that can produce reproductive and/or developmental effects at low dosages, for example where evidence exists of such effects being caused by a clinical dose of <10 mg>
低剂量即可以产生生殖反应和/或发育反应的化合物，例如，有证据证明此类反应是由临床剂量<10mg>（兽药剂量等于0.2mg/kg/天）或兽用研究≤1 mg/kg/天剂量引发。
3. Compounds that can produce serious target organ toxicity or other significant adverse effects at low doses, for example where evidence exists of such effects being caused by a clinical dose of <10 mg>
低剂量即可能会导致目标器官严重毒性，或其它重大不良反应的化合物，例如，有证据证明此类反应是由临床剂量<10mg>（兽药剂量等于0.2mg/kg/天）或兽用研究≤1 mg/kg/天剂量引发。
4. Compounds with a high pharmacological potency i.e. recommended daily dose of <1 mg (veterinary dose equivalent 0.02 mg>
具有高药效的化合物，即，建议日剂量<> (兽药剂量等于0.02 mg/kg)。
5. Compounds with a high sensitising potential.
具有高致敏可能性的化合物。
联系客服
