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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
UK MHRA Guidances: Ensuring Medical Device Safety in Great Britain: Field Safety Notices, Post-Market Surveillance, and Custom-Made Devices
In recent years, the MHRA has issued several key guidance documents strengthening the lifecycle safety and regulatory oversight of...
Sharan Murugan
Jun 18, 20253 min read
UK MHRA Guidance: Strengthening Post-Market Surveillance for Medical Devices
On 15 January, the Medicines and Healthcare products Regulatory Agency (MHRA) released a suite of guidance outlining the new PMS...
Sharan Murugan
Jan 21, 20252 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