Search
EMA Guidance: Electronic Submission of Medicinal Product Data under IDMP (Chapter 3 Explained)
The European Medicines Agency (EMA) continues to advance data standardisation and digital transformation in regulatory processes through the implementation of ISO IDMP standards and Product Management Services (PMS). The guidance Process for the electronic submission of medicinal product information – Chapter 3 (Version 3.5, updated 20 April 2026) provides detailed instructions on how medicinal product data should be submitted, managed, and maintained electronically throughou
Sharan Murugan
Apr 253 min read
EMA Guidance: EMA’s Implementation of ISO IDMP Standards Through Products Management Services (PMS)
To modernize and harmonize the management of medicinal product information, the European Medicines Agency (EMA) is actively implementing...
Sharan Murugan
Jun 23, 20252 min read
USFDA Guidance: Identification of Medicinal Products — Implementation and Use
Today (31 March 2023) USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released updated...
Sharan Murugan
Mar 31, 20231 min read
EMA updated Guidance: IDMP Products Management Services - Implementation Guide
On 8 July 2022, EMA updated its Products Management Services - Implementation Guide "Implementation of International Organization for...
Sharan Murugan
Jul 31, 20221 min read
EU IDMP Implementation Guide - version 2.0
EMA published the current version, version 2.0 (EU IG v2.0), in February 2021. It mainly serves to support the European medicines...
Sharan Murugan
May 3, 20212 min read