非洲各国卫生监管机构表示，目前正着手修订药品定制的相关规定，涉及广受欢迎的GLP-1类糖尿病及减肥治疗药物。监管机构同时警告各药店切勿充当小型药品生产商。
Africa is revising its rules governing the customisation of medicines, including sought-after GLP-1 treatments for diabetes and weight loss, health regulators said, warning pharmacies not to act as small-scale manufacturers.
周三，在一场关于假药问题的多方圆桌会议上，南非药剂委员会注册主任兼首席执行官文森特·特拉拉透露，该委员会正与南非健康产品监管局合作，共同制定药品定制领域的最新最低标准与指导方针。
At a multi-stakeholder roundtable on counterfeit medicines on Wednesday, South African Pharmacy Council Registrar and CEO Vincent Tlala said the council was working with the South African Health Products Regulatory Authority (SAHPRA) on updated minimum standards and guidelines for compounding medicines.
据特拉拉介绍，修订后的标准预计将于2月份提交委员会审议，并有望在3月份正式发布；南非健康产品监管局的相关指导方针也计划同期出台。
The revised standards are expected to go before the council in February, with publication targeted for March. Updated SAHPRA guidelines are expected to be released at the same time, Tlala said.
近年来，诺和诺德公司的奥泽美匹、韦戈维以及礼来公司的穆恩贾罗、泽普邦德等GLP-1类药物广受欢迎，这也促使定制版同类药品的生产量激增，引发了全球监管机构的密切关注。
The popularity of GLP-1 medicines such as Novo Nordisk's (NOVOb.CO) Ozempic and Wegovy and Eli Lilly's (LLY.N) Mounjaro and Zepbound has fuelled growth in compounded versions, drawing scrutiny from regulators globally.
所谓“药品定制”，即药剂师根据患者的特殊需求，调配出与市售药品有所差异的个性化药物。特拉拉指出，委员会担忧的是，部分药店并非为特定患者调配药品，而是为了迎合市场需求而大量生产。
Compounding refers to the preparation of customised medicines by pharmacists for patients needing a variation to a commercially available product. Tlala said the council was concerned pharmacies were compounding medicines in anticipation of demand rather than for specific patients.
“目前市场上出现的、也是我们所反对的现象，就是药店摇身变成小型药品生产商，”他说道。
"What we are seeing in the market, and which we are against, is when pharmacies become small-scale manufacturers," he said.
监管机构担心，大规模的药品定制行为可能为假药滋生提供可乘之机，尤其是在减肥药这类需求旺盛的药品领域。
Authorities are concerned that large-scale compounding may create openings for counterfeit medicines, particularly in high-demand categories such as weight-loss drugs.
南非健康产品监管局市场管控部门高级经理达芙妮·法富迪在会议间隙对路透社表示：“目前定制类药品泛滥成灾，减肥药领域尤为严重。”
"There is a scourge of compounded products, especially in the area of weight-loss," Daphney Fafudi, SAHPRA's senior manager for market control, told Reuters on the sidelines.
法富迪强调，此次发布的监管局指导方针以及药剂委员会修订后的最低标准，旨在明确药品定制行为的合规边界。
Fafudi said the updated guidelines from SAHPRA and revised minimum standards from the pharmacy council were intended to provide greater clarity on what is and is not permissible when compounding medicines.
现有法规中已包含关于复方制剂的规定，但对这些规则的不同解释导致了行业内的争议，包括当地药品复方公司iDexis与诺和诺德之间的诉讼。
While existing regulations already contain provisions governing compounding, differing interpretations of those rules have led to disputes within the industry, including litigation involving local pharmaceutical compounding company iDexis and Novo Nordisk.