Search Results for ISO IDMP

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Identification of Medicinal Products (IDMP) Standards Part 1: Impact on the Regulatory World By Dieter Schlaps - Published 21 December 2016

This is part one of a four-part series on the Identification of Medicinal Products (IDMP) standards and their respective implementation guidelines. This segment reviews the steps needed to prepare for their global implementation and offers technical solution options for the industry.

Categories: News, Europe, US, EMA, FDA, ISO, Biologics and biotechnology, Drugs

Tags: ISO IDMP, IDMP, Identification of Medicinal Products

Going Digital: EMA to Ditch Paper, Require Electronic Application Forms By Michael Mezher - Published 26 February 2015

In an effort to reduce its administrative burden, the European Medicines Agency (EMA) will soon require companies to use electronic forms for a number of application types. The move is part of a wider effort in the EU to transition to international and electronic standards.

Categories: News, Europe, EC, EMA, ISO, Drugs, Regulatory strategy, Submission and registration

Tags: eCTD, CTD, electronic application forms, eAFs, eSubmissions Roadmap, ISO IDMP

EU Task Force to Implement New Drug Identification Standards By Michael Mezher - Published 23 February 2015

The European Medicines Agency (EMA) has announced it is putting together a task force to oversee the implementation of new standards for identifying drugs.

Categories: News, Europe, EMA, ISO, Drugs, Postmarket surveillance

Tags: ISO, IDMP, XEVMPD

EMA Explains Centralized Product Database, Talks Future Changes By Michael Mezher - Published 18 February 2015

The European Medicines Agency (EMA) released a new document intended to clarify data submission requirements for medicines authorized in the European Economic Area (EEA).

Categories: News, Europe, EMA, ISO, Drugs, Postmarket surveillance

Tags: Pharmacovigilance, EudraVigilance, XEVMPD, ISO IDMP