Category: Regulatory Update

Brexit, Regulatory Update

ACUTA RIM Shots – August 16 Special Brexit Edition

Lots of Brexit-oriented news in recent days that affects the biotech industry. UK/EMA Separation Implementation Period First of all, in March, the EU and UK agreed to an ‘implementation period’ for medicines to give a little more time for the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) to  …

ARIM Publisher, eCTD, EMA, Regulatory Update

Regulatory Update: EMA eCTD Specifications 3.0.2 – Best Practices Limitation Corrected (even better practices!)

On April 6, 2017, EMA issued a new version of the eCTD specifications, version 3.0.2, 11 months after version 3.0.1. If you look at the EMA Website’s EU Module 1 page, it appears that nothing has happened: The same EU Regional DTD (the structure of the eCTD), and the same Implementation Guide are listed as …

eCTD, EMA, Health Canada, Regulatory Update

Regulatory Updates: European Electronic Application Form and Health Canada eCTD Mandate

Joel Finkle, Director Regulatory Innovation and Donald Palmer, Director Product Strategy A couple of announcements have been received from regulatory agencies impacting product application processes. European Electronic Application Form (eAF) First, EMA has updated the electronic Application Form (EAF). This is the interactive PDF form from which EMA extracts an XML representation of what your …