EMA增加需要在药品标签中标明的新辅料

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EMA Adds New Excipients to Labeling RequirementsPosted 09 October 2017
By Michael Mezher

The European Medicines Agency (EMA) on Monday updated its annex to the European Commission's guideline on excipient labeling, adding five new excipients and expanding the safety warnings required for 10 others.

Excipients are defined as any part of a drug other than the active pharmaceutical ingredient. Most excipients are thought to be inactive, though some can cause reactions in certain circumstances. For instance, lactose is commonly used as a filler in drug tablets, but can cause reactions in patients who are lactose intolerant.

The document, which lists the excipients that are "known to have a recognized action or effect" that must be declared in a medicine's label and package leaflet, is being updated for the first time since its publication in 2003.

The update also comes as the European Commission considers revisions to its excipient labeling guideline following a public consultation that closed in May.

The five newly listed excipients include boric acid（硼酸）, cyclodextrins （环糊精类）, phosphate buffers（磷酸盐缓冲液）, sodium laurilsulfate（十二烷基磺酸钠） and fragrances containing allergens（含有致敏原的香精）. The annex includes an appendix listing 26 specific fragrance allergens such as cinnamal and oak moss that are required to be included in labeling.

As for the new safety information, EMA says the revised annex "pays specific attention to…the safety of these excipients when used in children or pregnant women."  For example, the annex includes new safety information that must be listed in the package leaflet for drugs containing benzyl alcohol（苯甲醇） advising women who are pregnant or breast feeding to consult with their doctor or pharmacist before taking the drug.

EMA says the revised annex goes into effect immediately for all centrally and nationally authorized medicines, and current marketing authorization holders are instructed to update their product labeling at the first opportunity. For products with no upcoming regulatory submissions, EMA says sponsors should submit a type IB variation detailing any labeling changes within the next three years.

EMA

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　　第十一条　药品说明书应当列出全部活性成份或者组方中的全部中药药味。注射剂和非处方药还应当列出所用的全部辅料名称。药品处方中含有可能引起严重不良反应的成份或者辅料的，应当予以说明。
http://www.sda.gov.cn/WS01/CL0053/24522.html

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EXCIPIENTS IN THE LABELLING
According to Directive 2001/83/EC,  all excipients in parenteral, ophthalmic and topical medicinal
products must appear on the labelling. Topical medicinal products can be taken to include those
medicinal products applied externally to the skin, respiratory products delivered to the lung by
inhalation and any medicinal product delivered to the or al, nasal, rectal or vaginal mucosae, i.e. where
the delivery may be local or transdermal.
For all other medicinal products, only those excipients  known to have a recognised action or effect,
included in the Commission’s guideline, should be  declared on the labelling. Such excipients are
listed in Annex.
When a medicinal product contains any of these, the name of the excipient must be stated on the
labelling, together with a statement such  as 'see leaflet for further information'.
选自：https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/c/guidelines_excipients_july_2013_rev_1.pdf

Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668)
需要在相应的制剂labelIng上标注相关安全信息的辅料名单

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请问国内的这个名单在哪里获取呢？？？非常感谢！！！

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