About the Interactive Review Phase

During the submission process, the regulatory authority can require additional information. Market Registration provides tools to manage the interactive review phase, sometimes called the question-and-answer phase, of the submission process.

Note: You must create tasks that are specific to Market Registration, such as Interactive Reviews, Review Questions, or Regulatory Milestones, in the appropriate places in the app. You cannot create a project task, such as a Task, Phase, Gate, or Milestone, then change it to a Market Registration type task.

This page discusses:

See Also
Managing the Question and Answer Phase
Review Questions for the Regulatory Calendar

Interactive Review Phase and Review Question Tasks

After submitting a dossier, the regulatory authority might send a batch of questions with a deadline for answering those questions. You can use the Schedule or Timeline page tabs to define the interactive review phase with the individual questions defined as Review Question tasks.

When looking at the properties for an Interactive Review phase, you see the standard attributes plus the Received Date attribute indicating the date the batch of questions was received from th e Regulatory Authority.

When looking at the properties for a Review Question, you see the standard task attributes plus the Question Text and Answer Text attributes.

Market Registration lets you view the structure of the Interactive Review phases on the Review Questions page tab. This view includes columns specific to questions and answers. To access this page:

  1. View any page for the submission project.
  2. Click Schedule in the navigation pane.
  3. Click the Regulatory Calendar tab.
  4. Click the Review Questions tab.

Review Phase Process

The typical submission process follows these steps:

  1. The Regulatory Lead sends the original submission, with its complete dossier, to the Regulatory Authority.
  2. The Regulatory Authority responds with a set of questions, and a deadline for responding to those questions.
  3. The Regulatory Lead creates a new phase on the Schedule or Timeline page tab called Interactive Review, and creates a Review Question task for each question. The details for the task include:
    • Text of the question
    • Date the batch of questions was received
    • Deadline for the response
  4. The Review Question tasks are assigned to Regulatory Users to provide the answers.
  5. The Regulatory Lead sends a dossier containing the responses to the Regulatory Authority.

You could receive multiple batches of questions, and the batches could be in a series (questions received, responses submitted, more questions received), parallel (separate sets of questions to be worked on at the same time), or overlapping (questions received and while working on the responses, more questions are received).

Review Question Properties

The Properties page for a review question includes all fields that show for any task, plus these fields:

Field NameDescription
SeverityThe severity for the review question: Low, Medium, or High.
Question TextThe question asked by the regulatory authority.
Answer TextThe answer to the above question.