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News dal mondo

24

Feb

New Zealand seeks feedback on adopting new PIC/S Guide to GMPs

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is holding a public consultation on its proposed adoption of the updated PIC/S Guide to Good Manufacturing Practices (GMPs).

PIC/S, the Pharmaceutical Inspection Co-operation Scheme, adopted the latest version of its GMP guide in 2018. The update affected sections covering recalls, real-time release and other topics.

Medsafe has summarized the main changes to its current code, released in 2009. Since then, revisions have occurred – some minor, but others more substantive. Medsafe noted significant changes to the information on cross-contamination and starting materials, as well as the substantial expansion of the section on complaints and product recalls.

 Medsafe is accepting feedback until 22 March. The agency plans to notify stakeholders of its final decision by 12 April, setting it up to use the new code as its terms of reference from 3 May. Medsafe plans to give the industry until 3 November to fully implement the code. From May to November, the agency will allow companies found to be deficient against the new code to propose a timeline for implementation of corrective actions. Medsafe accepts the timelines may be longer than is typical...[MEDSAFE]

22

Apr

Update on the Ph. Eur. policy on elemental impurities – Monographs on substances for veterinary use only

he European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its proposal to delete...

20

Apr

US GDUFA III: Use MDUFA model to create competition in generic drug markets

To design an effective financing system for generic drug approvals, the FDA must balance the need...

20

Apr

Pharmaceutical reshoring: a strategic necessity

More than a year into the COVID-19 crisis, the novel coronavirus continues to disrupt our societies,...

19

Apr

Covid-19 ministro Speranza firma nuove Ordinanze per contenere la diffusione del virus

Il Ministro della Salute, Roberto Speranza, sulla base dei dati e delle indicazioni...

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