The eCTD Deadline is Looming: Are You Ready?

For those of us working in the regulatory affairs sector, there is always a deadline to contend with.  We deal comfortably with client deadlines every day.  However, the new deadlines that are causing the most unease in the life sciences sector are those relating to the electronic common technical document or the eCTD as it is better known. Editor’s Note:  This article was first published in 2017.  Since then, much has changed in eCTD.  You can stay up to date with all of our eCTD related news by clicking here. Many years ago, we were vocal advocates for the introduction of electronic publishing.  We, at Acorn Regulatory, were also one of the earliest adopters of the eCTD system. After all, who in the regulatory affairs  sector will ever forget the boxes of paper that had to be produced for submissions? Earlier this year, on January 1st 2017, the eCTD format became mandatory for all Marketing Authorisation Applications (MAA’s) submitted through the Mutual Recognition Procedure (MRP). Now, an even bigger and more challenging deadline is approaching.  January 1st 2018 will see everything move to the eCTD format.  For many companies, particularly smaller entities, this will pose a significant challenge.  We already provide electronic publishing eCTD services to a large number of companies.  These companies, while sometimes equipped with a full time regulatory resource or department, have opted not to adopt the eCTD publishing software.  For some companies the cost of such an eCTD system might be prohibitive and for others there may be a business case for not purchasing such software as the number of submissions to be carried out annually might not make sense from a business perspective. That is why it is more effective or cost-efficient for these companies to use our electronic publishing eCTD service. So, from January 1st 2018 all activities must be handled through eCTD.  This will pose a problem for many, many companies who do not have such an in-house capability.  The mandatory deadline is looming and these companies have the greatest hurdle to vault in order to be compliant in 2018. Right now, we are dealing with many requests from companies that are getting ready for the January 1st deadline.  Our team of publishing experts have been advising each one, on an individual basis, to ensure that their company has a smooth path to the January deadline.  Our publishing experts have found that the companies that are dealing with the looming deadline now are reducing the possibility of last minute hiccups by taking their time to get everything in order in good time. As always, we are happy to have a chat with any company, particularly if you are concerned about your readiness for January 1st 2018.  Feel free to call us on 00353 52 61 76 706 or complete your details below and we will get back to you as soon as we possibly can. [ninja_form id=1]

Further Reading from Acorn Regulatory

Veterinary Clinical Trials: New EU Law & Global Approaches

Clinical studies are intended to advance animal health care by identifying the most effective therapies and practices for a given condition, or by advancing our basic understanding of the disease. Much like a clinical study in the human population, a veterinary clinical study involves research that gains information from animal patients. Read more here.

Pharmacovigilance & Social Media in 2020

We have been tracking the role of social media in pharmacovigilance in social media since 2015.  We first wrote about it here.  5 years on, we are glad to say that the field has moved on substantially in terms of research into the practical applications of social media in Pharmacovigilance. Regulatory guidance for the industry, however, has yet to be updated. Read the full article here.

Download Our Clinical Trials E-Book

Acorn Regulatory is a leading regulatory, pharmacovigilance, and clinical consultancy company headquartered in Ireland.  Our Clinical & Medical team works with the largest and the leading companies in life sciences to assist them in bringing their products to market.  The team, led by Dr. Danica Cvetkovic, has written extensively on the issue.  In the latest e-book from Acorn Regulatory, we look at the best and most popular articles from our Clinical & Medical team. Download the e-book here.

A Practical Approach to Risk Management Plans

Writing a risk management plan (RMP) for the first time can be a daunting task. The RMP is a legally binding regulatory document submitted to health authorities and is a mandatory commitment for all Marketing Authorisation Holders in the European Union. The goal of the RMP is to improve the benefit-risk balance of a medicinal product by combining risk assessment and risk minimisation. The RMP is a complex document, but with the revised RMP module (March 2017), comes the revised EU template for RMPs (rev 2 format) and the RMP is now structured in a clear manner with less repetition and with attention to detail. Read more here.