Abstract：
Nomenclature has always been a source of debate in the scientific literature. In the context of pharmaceutical regulation, varying interpretations of technical language can emerge due to philosophical or linguistic differences between two expert groups, which may undo efforts to harmonise regulatory approval mechanisms for new medicines. This letter describes three examples of divergence within pharmacopeial texts produced in the US, EU and Japan and suggests how these have emerged. Ultimately, I advocate for a consensus and an all agreed upon terminology that would be helpful for the global pharmaceutical industry, as opposed to many agreements between individual manufacturers and regulators of medicines, which may reintroduce variation in regulatory standards.
摘要：
命名法一直是科学文献中争论的焦点。在药品监管的背景下，由于两个专家组之间的哲学或语言差异，可能会出现对技术语言的不同解释，这可能会取消协调新药监管审批机制的努力。这封信描述了在美国产生的药典文本中存在分歧的三个例子，欧盟和日本，并提出了这些是如何出现的。最终,我主张达成共识，并就有助于全球制药业的术语达成一致，与单个药品制造商和监管机构之间的许多协议相反，这可能会重新引入监管标准的变化。
