Regulatory Operations, Resources and eCTD Benefits

Posted 04 April 2018 | By Gloria Hall 

Regulatory Operations, Resources and eCTD Benefits

Articles posted throughout March included in-depth coverage on the use of electronic Common Technical Documents (eCTDS), regulatory resources and operations, FDA's citizen petition process and ASEAN harmonization efforts.

eCTD Update

The deadline after which all Investigational New Drug Applications (INDs), Drug Master Files (DMFs) and their amendments will be required to be both in Common Technical Document (CTD) format and submitted electronically (collectively called the eCTD) is fast-approaching. There are several informative websites, including many posted by the US Food and Drug Administration (FDA), providing useful information about the conversion from paper to electronic submissions. Principal consultant and regulatory intelligence expert, Meredith Brown-Tuttle, shares a reference guide to help regulatory professionals navigate the electronic Common Technical Document (eCTD) steps necessary for successful compliance in "Electronic Publishing Conversion: A Reference Guide to Converting Paper Submission to eCTD."

In a collaboration with another regulatory intelligence expert, Laurie Isaacson, Brown-Tuttle explains a process for converting from paper-based Investigational New Drug (IND) applications and Drug Master Files (DMFs) to submitting IND/DMFs in an eCTD format. "Budgeting for the IND in an eCTD Format–to Outsource or Insource?" offers tips on how to make a smooth conversion and discusses the relative merits of in-house work versus outsourcing to comply with the approaching deadline. The authors also present information for estimating the costs of outsourcing.

Around the world, the eCTD is becoming the mandated submission format for drug applications as the move away from paper is environmentally important and facilitates the submission review for both health authorities and sponsors. FDA, EMA, Health Canada and Swissmedic as well as many other health agencies are accepting eCTD as a standard. Two leading regulatory experts from Accenture, Jillian Carinci and Sandra Krogulski, discuss the growing requirement by health agencies for eCTD submissions rather than paper applications and explore how this move can be beneficial for organizations in "Regulatory Operations: Leveraging eCTD Benefits."

Leading regulatory affairs manager, Viviana Mascilongo, outlines the global status of eCTD and its implementation impact on companies. "eCTD: A Global Regulatory Overview" provides an international overview and focuses on regulatory eCTD submission requirements and global harmonization for medicinal products for human use in Canada, Europe, Japan and the US. Tips for organizing common technical documents are included.

eCTD as a standard of transfer of regulatory information from industry to agency was signed by the International Council for Harmonisation (ICH) in October 2003. Since the release of these initial versions, ICH's eCTD standard and regional specifications (Module 1) have been updated multiple times to correct initial design flaws and to reflect the evolution of the regulatory requirements. Experienced regulatory experts, Ted Hanebach and Joanne Knox, examine regulatory requirements established by agencies in the US, Canada and European Union. "Regional eCTD Validation and Acceptance Criteria: Comparing FDA, Health Canada and EU Requirements" describes how the eCTD standard has been changing to support this evolution.

eCTD is the standard format for submitting applications, amendments, supplements and reports to FDA's Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) for investigational new drug applications and drug master files. Global regulatory expert, Pallavi Trivedi, discusses what companies need to know to prepare a compliant submission under the eCTD format in " eCTD Transition: Preparing for a Compliant Submission."

Policy and Trends

FDA regulations provide for a citizen petition process enabling the public to request FDA to take or refrain from taking a certain action. The citizen petition process also is used to bring other issues to FDA's attention, such as concerns about the safety of an approved product. Three well renowned legal powerhouses from Arnall Golden Gregory provide an overview of FDA's citizen petition process as it relates to the drug industry and highlight several key issues raised by this process. Alan Minsk, Deborah Livornese and Genevieve Razick focus on 505(q) and discuss its potential implications in "FDA Citizen Petitions: What They can and Cannot do."

Harmonization

Regulatory affairs specialist, Justyna Kwiatkowska, describes efforts at creating pharmaceutical regulatory harmonization in Southeast Asia spear-headed by the Association of Southeast Asian Nations (ASEAN). "Current Regulatory Harmonization Efforts in ASEAN Countries" discusses current barriers and issues representing challenges to harmonization, such as different strategies and social and cultural realities among the 10-member nations participating in ASEAN. Efforts at harmonization conducted by ASEAN's Pharmaceutical Products Working Group developing a pan-ASEAN regulatory harmonization scheme are detailed.

What's Coming in April

April feature articles will cover re-designing regulatory capabilities, new expanded access policy requirements and programs, including for medical devices, orphan drug programs, a harmonized gene therapy model, regulating gene therapies and economic challenges, and a review of US and EU veterinary devices.

Look for these topics and more in April. Have a suggestion for a feature article? Contact Gloria Hall at ghall@raps.org.


Categories: Feature Articles

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