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10

Mar

European Pharmacopoeia Commission creates new Excipients Strategy Working Party

uring its 173rd session in June 2022, the European Pharmacopoeia Commission (EPC) approved the creation of a new Excipients Strategy Working Party (EXS) (see “Outcome of the 173rd session of the European Pharmacopoeia Commission, June 2022”). The EXS Working Party will focus on continuing to address the specificities of these important pharmaceutical ingredients in European Pharmacopoeia (Ph. Eur.) monographs and will also reflect on how best to further develop the Ph. Eur. excipient strategy.

The Ph. Eur. general monograph on Substances for pharmaceutical use (2034) covers both active substances and excipients. However, several parts of this general monograph, as well as the Technical Guide for the Elaboration of Monographs, apply only to active substances... [EDQM]

22

Mag

5 Emerging Trends In Complex Small Molecule Drug Production

Product development of new generic molecules starts early in the life cycle of the originator product...

18

Mag

Carenze di farmaci. EMA pubblica 10 raccomandazioni per le aziende

La guida descrive le varie parti interessate nella catena di approvvigionamento dei medicinali, le loro...

18

Mag

Report Egualia: Generici, mercato fermo al palo, si rischia che questi farmaci spariscano

Ancora un anno sospeso tra stagnazione e depressione per il mercato italiano dei generici-equivalenti...

17

Mag

Carenze farmaci: una proposta per tornare al “Made in Europe” e ridurre la dipendenza dai fornitori (come Cina e India)

After the European Commission proposed a massive overhaul to the EU’s drug legislation,...

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