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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 20 Good manufacturing practice (GMP) Commission Directive (EU) 2017/1572 (which supplemented Directive 2001/83/EC) lays out the principles and guidelines of GMP in the EU. 2012/1916).

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EU pharmaceutical legislation revisions: what are the implications for biopharma?

European Pharmaceutical Review

In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents. In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents.

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Preparing for stricter standards on substances of human origin

European Pharmaceutical Review

SoHO entities must implement a traceability system to unmistakably link each SoHO donor to their SoHO donation and to all documents, samples, SoHO preparations and SoHO entities that are associated with that SoHO from the point of collection to human application and outcome monitoring.

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Air Quality and Hashimoto’s – Is the Air You’re Breathing Making You Sick?

The Thyroid Pharmacist

Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, For sunscreens and other over-the-counter drugs, fragrances must be identified on the label. But formaldehyde has been labeled as a known human carcinogen by the U.S.