Regulatory Blog

As regulatory systems become increasingly digital, standardized medicinal product data has become essential for improving regulatory efficiency and ensuring consistent information across the European medicines network. To support this transition, the European Medicines Agency (EMA) published the guidance Product Management Services (PMS) – Implementation of ISO Standards for the Identification of Medicinal Products (IDMP) in Europe – Chapter 3: Process for the Electronic Subm

The Guidance on the electronic submission of information on investigational medicinal products for human use in the Extended EudraVigilance medicinal product dictionary (XEVMPD) was updated on 13 April 2026 (Version 1.5) , providing detailed procedural and technical instructions for sponsors submitting clinical trial product data. Introduction This guidance provides consolidated instructions for sponsors on how to electronically submit information on investigational medici

The United States Food and Drug Administration (USFDA) has released detailed guidance" Standardized Format for Electronic Submission of...

Yesterday (06 February 2024) Switzerland's Swissmedic released updated guidance on "Electronic exchange of ICSRs through PV Gateway", and...

This document was issued on September 22, 2022. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be...

This Document supplements the Guidance Document: Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format: IND...