With an ever-increasing regulatory landscape, it is important to know what is coming next. Looking into regulatory world – we are aware of some changes that are coming along the way and we are certain that these will affect many of us. Therefore, it is crucial to be prepared for all the changes. We at Cunesoft believe in the importance of sharing knowledge and helping each other to prepare for upcoming regulations. Therefore we would like to share with you the summary of some important regulatory activities that are coming next year and beyond.
Recently, the FDA held a free webinar in its CDER Small Business and Industry Assistance (SBIA) Webinar Series on “OPDP Electronic Submissions – Common Errors in eCTD and How to Avoid Them”. The Cunesoft team took part in this webinar and created a summary of most common errors seen in promotional submissions in eCTD format. Read More
As part of our continuous global regulatory updates and in case it did not catch your attention, please be reminded on the Health Canada revised validation rules for regulatory transactions in the electronic Common technical Document (eCTD) format, which are applicable since March 30th, 2019. Read More
The adoption of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic Devices (IVDR) changes the way medical devices will be regulated going forward. Read More
While the EMA is currently busy moving to the Netherlands and while the IDMP project currently seems to go slow, there is definite and significant progress being made in the background. The latest achievement is a major overhaul of the ISO/TS 19844 “Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances”. Read More
Australia is phasing out eCTD Specification version 3.0 on 30th June 2018. The Therapeutic Goods Administration (TGA) is making changes with eCTD validation criteria, specifically current eCTD Document Matrix (Version 2.0) which forms part of the validation criteria for the eCTD and NeeS and which is one of file downloads for eCTD version 3.1. Read More
The implementation process of SPOR over several phases… that’s nothing new. However, after the 6-month delay due to the Brexit and the EMA relocation, there are some new actions planned for later this year. In the following we share the news from the last EMA webinar a few days ago: Read More
eCTD becomes more and more mandatory in different regions and for various submission types. Soon only the eCTD format will be accepted throughout the marketing authorisation of drugs. One of the regions announcing eCTD as a mandatory format to be used for drug applications is Health Canada. Read More