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News from the world

26

Feb

EMA updates IDMP Implementation Guide, plans further revisions

EMA has updated its identification of medicinal products (IDMP) implementation guide, providing additional details on topics including the basis for medicinal product data exchange in the European Union in its version 2.0.

 EMA picked out the addition of “high level principles of the target operating model for submitting and maintaining medicinal product data in the EU” as an area that has changed since version 1.0. EMA has also added further advice on how to populate the product management service (PMS) data elements.

 The new content adds to the early information on EMA provided on technical specification, data elements and associated business rules last year to help the industry prepare for the implementation of IDMP standards.

 Following the update, EMA said the text features detailed guidance on the registration requirements, information on product data access and practical examples intended to help users structure product data correctly. The guide is intended to form the basis for practical preparation activities and give the European regulatory network the information needed to submit data.

 Step 1 of PMS implementation is set to start at least 12 months after the release of version 2.0 of the IDMP guide. Tweaks to version 2.0 are planned for later in the year. EMA said no substantial changes to the submission process are planned. Rather, EMA will use the updates to add details about the migration and enrichment of data.

 EMA is also starting to make plans for a third version of the guide that will be designed to support step 2 of the PMS implementation. The third version will feature additional chapters covering step 2 of the implementation...[EMA]

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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