Creating a Regulatory Authority

You can add a regulatory authority to provide details about submission types, regulatory categories, and regulatory guidelines that you use to configure Market Registration.

Required access role: Regulatory Administrator

Before you begin: View the list of regulatory authorities. See Regulatory Authorities List.
  1. Do one of the following:
    1. Click Add > Market Registration > Create Regulatory Authority.
    2. From the page Actions menu or toolbar, click Create Regulatory Authority .
  2. Enter these details:

    Field NameDescription
    TitleThe descriptive name of the authority.
    DescriptionAdditional descriptive information about the authority.
    Country StabilityDescriptive information about how stable the government is.
    CountryClick to search for and select one or more countries. The system updates the list of languages based on your choice. You can only add active countries.
    LanguageSelect a language from the list.

  3. Click Done.

Market Registration assigns a name using this format: REGAUTH- followed by the next sequential number.

To complete the definition of a regulatory authority:

  • Define the reviewers within the authority that your company deals with. See Reviewers List.
  • Add reference documents.
  • Add submission types.
  • Add regulatory categories.
  • Add countries.
  • Promote the regulatory authority to the active state.