Description
Demonstrate understanding of the history and impacts of the ICH’s development of eCTD
Describe the founding regions of the ICH as well as the makeup of the ICH membership with respect to agencies and observers
- Demonstrate knowledge of the basic structure of the eCTD
- Demonstrate an understanding of the basic aspects of the role of regulatory affairs in the eCTD submission process
- For this assignment, you are a Sr Manager of Regulatory Affairs at a small, emerging biotechnology company called Silencia Therapeutics. Your company has recently successfully developed a new drug and now, you and your cross-functional colleagues at Silencia Therapeutics are planning to submit your company’s first New Drug Application (NDA) to the FDA and a Marketing Suthorization Application (MAA) to the EMA.
- Silencia is a small company of only 15 employees and you are the only regulatory affairs professional in its employ. As Silencia is a small company, most of its employees do not know what ICH or the eCTD are and require some help from their regulatory affairs team members!
As the Sr Manager of Regulatory Affairs, it is your task to develop an Executive Brief that you will deliver to your peers and also the Chief officers (including CEO!) of the company. Your executive brief needs to be 5 – 7 pages and needs to include, at a minimum, a review of the following information:
An introduction to ICH, its history, and its current membership. What countries formed the ICH? Are regulators and industry professionals able to join?
An overview of the basics of electronic CTD. What is the eCTD and why has ICH developed this dossier format? What are the major differences between eCTD submissions to the FDA vs. EMA?
A review of the benefits of eCTD. How does eCTD help to improve the drug development process?
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FDA AND ECTD WRITING ASSIGNMENT
FDA and eCTD Writing Assignment #1
[Student Name]
[University/Institution]
[Course Title]
[Date Submitted]
1
FDA AND ECTD WRITING ASSIGNMENT
2
Prepared for the attention of:
•
Chief Officers of Silencia Therapeutics
•
Regulatory Affairs Department Employees
Prepared by:
1. [YOUR NAME], Sr Manager, Regulatory Affairs
Statement of Purpose:
The main objective of developing the report is to provide a detailed description of the
International Council for Harmonisation (ICH) and how to relate it to eCTD to determine how it
will affect the daily operation of Silencia Therapeutics, especially when it comes to the
development and evaluation of new drugs. By the end of the brief, everyone should have new
insights into the way the two institutions will shape the way we will develop the New Drug
Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the EMA
to ensure that the new drugs are approved and that a set foundation of organization growth and
development is established.
SECTION 1. Introduction to ICH:
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for
Human Use, abbreviated as ICH, was first pioneered by the E.C., in Europe in the 1980s. The
objective of developing it was to develop a single market for pharmaceutical products. After
successfully implementing the organization in Europe, more serious discussions between Europe,
the U.S., and Japan emerged to harmonize the pharmaceutical industry. A significant step
towards achieving this was done in 1989 at the WHO Conference of Drug Regulatory
FDA AND ECTD WRITING ASSIGNMENT
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Authorities (ICDRA) in Paris. The birth of ICH finally happened in 1990 after authorities
approached the International Federation of Pharmaceutical Manufacturers and Associations
(IFPMA) in Brussels. Afterward, Japan (MHLW/PMDA), U.S (FDA), and Europe (E.C.)
Representatives of the regulatory agencies and industry associations met to plan an International
Conference. They later met and developed Terms of Reference and decided the three criteria of
harmonization, Safety, Quality, and Efficacy that would be used for approving and authorizing
new products.
Since then, the organization has evolved immensely. A significant modification in the
organization happened on October 23 in 2015 when they held the Inaugural Assembly meeting.
The modifications included having increased international outreach, providing more in...