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The eCTD Summit Celebrates 8th Anniversary with New Layout

While the online world has radically changed during the past 8 years, our approach of creating quality content has not. The eCTD Summit blog will continue to be a source of objective information on all things eCTD and regulatory submissions. Articles on the site are based on facts and stripped of bias. We want the site to be a trusted place our readers can regularly return to for updates on industry news, initiatives and best practices.

eCTD Adoption Among Major Reforms Underway in China Pharmaceutical Market

If history is any indication, the China Food and Drug Administration’s (CFDA) adoption of eCTD will also outpace anything previously seen at other regional health agencies. Moving to eCTD submissions is just one of many initiatives currently underway in China as part of an effort to reform regulation of the pharmaceutical industry.

Rules for Submitting Electronic DMFs to FDA, Health Canada

The U.S. FDA and Health Canada have each updated their submission requirements for Drug Master Files (DMFs). Understanding each agency’s requirements will be critical to compliance in the coming months as eCTD mandates go into effect.

Transparency Vital to Regulatory Publishing Projects

Agile relies on transparency. Decisions to optimize value and control risk are made based on the perceived state of the artifacts. To the extent that transparency is complete, these decisions have a sound basis. To the extent that the artifacts are incompletely transparent, these decisions can be flawed, value may diminish and risk may increase.

Submission Tracker, Issue Log Key to Agile Regulatory Publishing

The Submission Tracker is a list of every document that will be submitted to an Agency. The Submission Owner is responsible for the Submission Tracker, including its content, availability, table of contents sections, document production date, title, ordering and status of the document in the publishing process. For simple submissions (e.g. small amendments) the Submission Tracker could simply be a list of documents. Either way the Submission Tracker should have attributes that help estimate the publishing effort

Managing Regulatory Publishing Projects Using Agile

When following the Agile Methodology for Regulatory Submissions, events are used to create regularity and to minimize the need for meetings outside of the methodology. All events are time-boxed, meaning every event has a maximum duration. Once a Sprint begins, its duration is fixed and cannot be shortened or lengthened. The remaining events, such as Daily Stand Up Meetings, may end early if they have achieved their purpose, but cannot run over the allotted time. Such an approach ensures that an appropriate time is spent without introducing wasted effort into the process.

Five Points to Consider When Selecting an Enterprise eCTD Viewer

When selecting a system for cross-department viewing of eCTD submissions, as well as archiving, here are some important points you’ll want to give proper attention.

Agile Regulatory Publishing Team

A team using the Agile for Regulatory Submissions methodology consists of a Submission Owner, Publishing Team, and a Submission Coordinator. Agile teams are self-organizing and cross-functional. Self-organizing teams choose how best to accomplish their work, rather than being directed by others outside the team. Cross-functional teams have all competencies needed to accomplish the work without depending on individuals outside of the team structure. The team model integral to Agile for Regulatory Submissions is designed to optimize flexibility, creativity, and productivity.