The road to implement monumental changes which affect all segments of an industry is often full of roadblocks and milestone achievements, and the move to a fully electronic submission system requiring mandatory e-filing has been no different. For North America’s major regulatory agencies Continue reading
In an announcement made April 24, 2017 Health Canada reaffirmed its intent to transition all regulatory submissions over to eCTD format. Starting Continue reading
The recent trend of increasing CGMP violations involving data integrity identified during FDA inspections has created a cause for concern with the agency. This trend is “troubling because Continue reading
On February 3rd, 2016, Health Canada announced a revision to the guidance on Preparation of Drug Regulatory Activities in the “Non-eCTD Electronic-Only” Format, which was published in September 2015, to include Division 8 drugs and Clinical Trial regulatory activities in “non-eCTD electronic-only” format.
This document outlines the filing requirements and Continue reading
On February 19, 2015, the ICH M8 electronic Common Technical Implementation Guide (eCTD IG) reached step 2b of the International Conference on Harmonization (ICH) process1. Pursuant to the process a Continue reading
On December 08, 2014 US Food and Drugs Administration (FDA) issued draft guidance for industry entitled “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.” This guidance provides recommendations to sponsors on Continue reading
The introduction and acceptance of electronic submissions as the preferred submission process has been adopted at varying rates by different jurisdictions within the three ICH regions over the past several years. This move to provide a harmonized format has Continue reading
The Pregnancy and Lactation Labeling Rule, formally known as the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling (PLLR) has been published by the FDA.
The PLLR has been put into place in order to assist health care providers in Continue reading
The EMA has released a new finalized guideline called Similar Biological Medicinal Products which introduces the main concept of the “possibility for drug product developers to use comparators authorized outside the European Economic Area (EEA)” during clinical development of biosimilars.
The new guidance Continue reading
As part of Health Canada’s “ongoing efficiency measures and efforts to reduce regulatory burden on industry and transition to an electronic environment, … [Health Canada announced Continue reading