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
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
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
Yesterday US FDA has published a new guidance “M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use – Guidance for Industry”. FDA has addressed recommendations for eCTD 4.0. The guidance also provides separate tables describing the recommended granularity for paper and eCTD v3.2.2 submissions, and for paper and eCTD v4 submissions.
As one of the last actions in 2016 (effective December 17, 2016) the FDA enforced some new criteria that will allow them to reject an eCTD submission if there is non-compliance with key study data requirements.
FDA notes in their guidance “The standards apply to the following types of submissions to CDER and CBER: