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Regulatory submissions and transactions with Health Canada

By Robert Labriola We’ve seen recent trends and activity with regards to pharmaceutical regulatory submissions to Health Canada. Several questions and queries have come into our regulatory operations department, and the following information will address a few popular topics.  Health Canada implements eCTD for Clinical Trial Applications Health Canada accepts electronic Common Technical Document (eCTD) … Continued

Final Guidance Includes eCTD Implementation Date for Promotional Materials Submissions

Final Guidance and Implementation Date The U.S. Food and Drug Administration (FDA) has released long-anticipated final guidance with the implementation date for all promotional materials submissions via electronic common technical document (eCTD) format. The guidance titled, “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs” defines … Continued

Health Canada eCTD Update

Last month, Health Canada announced an update to the mandatory use of the electronic Common Technical Document (eCTD) format.  As with other agencies and regions, this helps move Health Canada towards a common submission intake process, as well as standardize and improve its business processes and tools. Previously, as of January 2018, New Drug Submission … Continued

FDA’s New ANDA Submissions Guidance: Key Points

The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance on September 24. The final guidance for industry titled, “ANDA Submissions – Content and Format” is intended to assist applicants in preparing complete and fileable abbreviated new drug applications (ANDAs) for submission to FDA. The primary purpose of this guidance is to … Continued

Updated EU eCTD Validation Criteria

The European Medicines Agency (EMA) updated version 7.1 EU eCTD Validation Criteria will come into force September 1, 2018. The changes in the validation criteria relate mainly to change requests received from regulatory bodies and taking experiences with version 6.1 into account. Click here for the Release Notes for the EU eCTD Validation Criteria version … Continued

Achieving Compliance with the FDA’s eCTD Mandate

The US Food and Drug Administration (FDA) has set May 5, 2018 as the compliance date for submitting many types of files—Drug Master File (DMFs) and commercial investigational new drugs (INDs)—in the electronic Common Technical Document (eCTD) format. A DMF provides confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, … Continued

NeeS: A Thing of the Past

With 2018 well underway, if you’re still not submitting in electronic Common Technical Document (eCTD) format in Europe, now is the time to transition. Non-eCTD electronic Submission or “NeeS” have been accepted for many years. However, they are becoming less common for National Procedures. Furthermore, at the end of this year, NeeS will be a … Continued

The Role of a U.S. Agent

Foreign sponsors of drug applications who want to conduct business in the United States need an authorized U.S. Agent to interact with the FDA on their behalf. Expectations for the individual or company serving as the U.S. Agent should go beyond forwarding email and monitoring the fax machine. The U.S. Agent should add value in … Continued

Submitting eCTD in Advance of a Milestone Application

While advanced GPS systems and the advent of Big Data analytics are negating some of their advantages, early birds are still capturing worms at a good clip. We’ve heard this slogan since childhood. For those of you planning to implement eCTD, the early bird’s experience rings true. Many people erroneously believe that your first eCTD … Continued

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