About Regulatory Calendars

Regulatory guidelines for a submission procedure include a calendar that defines the turn-around time for the tasks required to process the submission covered by those guidelines. A regulatory authority could define multiple calendars for the same combination ofregulatory activity category,regulatory activity category and regulatory activity subcategory. One calendar could support the normal submission process and another one could support a fast track submission process.

That calendar is defined in Market Registration as a regulatory calendar template.

The calendar includes phases and milestones specific to the regulatory process. The top-level of the calendar is the Regulatory Calendar phase, and it can also include Interactive Review phases. The phases contain the milestones required for that particular regulatory context. You define a regulatory milestone using the Regulatory Purpose attribute (see Regulatory Milestones).

Each regulatory calendar template has one global calendar that defines the regulatory phases and milestones for the complete submission procedure for all involved organizations. In addition, the template can include local calendars and global and local escalation calendars.

Milestones in the global scope affect all the organizations involved in the process. For regulatory procedures that encompass multiple authorities, the calendar has a global regulatory calendar, with the ability to connect local calendars at specific milestones. Milestones in a local calendar affect a specific country.

For specific circumstances, the regulatory authority can escalate the calendar, which results in changes to the dates and milestones. The regulatory calendar template can include pivot milestones that allow escalation calendars to be added at that point. When that template is used in a submission schedule, the escalation calendar can be added if needed. The app then recalculates all dates and dependencies based on the milestones defined in the escalation calendar.

Pivot milestones indicate those milestones at which an escalation calendar can be raised as defined by the regulation guidelines. Connection milestones indicate those milestones at which you can connect a local regulatory calendar.

The regulatory authority needs to inform the applicant company when an escalation calendar should be used. The switch of calendars can happen several times during the authorization process.

The regulatory guidelines approved by the regulatory authority define the regulatory calendar phase of the submission process. A non-detailed calendar could simply have a milestone to start the process (regulatory purpose is clock start) and a milestone to complete the process (regulatory purpose is market authorization). A detailed regulatory calendar includes as many milestones as needed. Milestones can indicate actions that need to be completed by either the applicant company or by the regulatory authority. For example, the regulatory authority can have a milestone for submitting questions, and the applicant company has a milestone for answering those questions.

When you define a regulatory calendar template or add a regulatory calendar phase to a schedule, Market Registration automatically adds the clock start milestone and market authorization milestone. The end date of the dossier submission part of the schedule is when the regulatory authority receives the dossier. At that point, the regulatory calendar phase begins. The date for the first regulatory milestone, for clock start, is communicated by the regulatory authority to the applicant. All subsequent dates are determined by turn-around times in the regulatory guidelines and milestone dependencies.

You can define regulatory milestones within the regulatory calendar phase. If you need to import an escalation calendar, the app automatically converts mandatory milestones to optional so that they can be deleted and the new milestones defined.

To define a milestone as a regulatory milestone, you assign it a regulatory purpose. Some milestones, such as clock start, can only occur once in a submission calendar. Other milestones, such as question, can occur multiple times.

The clock tracks the numbers of days required for milestones to be reached.

The regulatory authority can trigger a clock stop, meaning that the count of days stops. For example, if you have 2 days between two milestones, a clock stop of 10 days now allows you 12 days between those milestones. The dates for all subsequent milestones are also recalculated based on the clock stop. As an example, this table lists sample milestones for a simple calendar that includes 2 question-and-answer cycles.

Market Registration lets you import the structure for a regulatory calendar template from a comma-separated values (.csv) file. The CSV files must contain these columns in this exact order. You can omit column headings, or you can include them. If you include them, you can use any text you want because the headings are not imported, only the data is imported.

If a column has no data, such as the dependencies column when no dependencies are defined, that column must still be included. The file can include blank lines.

The import tool validates the file. If any of these tests fail, the file is not imported and a message explains the problem.

• The file must be a .csv (comma-separated values) file. No other file types are supported.
• The Task Level must be a numeric value.
• The Task Type column does not contain a valid value or does not follow the defined hierarchy for regulatory calendars.
• The Duration column must be a numeric value.
• The Dependency value must not be enclosed in quotes, and any task included in the dependency must be a valid task in this file.
• The username must be a valid person in the 3DEXPERIENCE system.