Configuring Regulatory Activity Categories

You can configure the regulatory activity categories and subcategories used when defining regulatory contexts.

  1. Create or open the text file for customized properties. For more information, see Editing Properties Using MQL.
  2. To define regulatory activity categories and subcategories, follow these steps:
    1. Add or edit this line in the file used to import properties into a page object:

      Regulatory.Activity.<NAME>.SubCategories=<VALUE1|VALUE2|...>

      The file must contain a property for each regulatory activity category (<NAME>) your company requires.

    2. Replace <NAME> with the name of the regulatory activity category. Convert any spaces in the name to underscore characters. For example, to specify the Initial Submission category, replace <NAME> with Initial_Submission.
    3. Replace <VALUE1|VALUE2|...> with the names of subcategories for that category. For example, replace <VALUE1|VALUE2|...> with IA|IAIN|IB|II-Extended|II-Reduced|II-Standard.
    For reference, the Regulatory.properties file includes these regulatory activity categories and subcategories definitions by default:
    Regulatory.Activity.Variation.SubCategories=IA|IAIN|IB|II-Extended|II-Reduced|II-Standard
    Regulatory.Activity.Commitment.SubCategories= Internal/External
    Regulatory.Activity.RestrictedAuthorization.SubCategories=Tender Offer|Authorization of 
    Temporary Use – Nominative|Authorization of Temporary Use – Cohort

    These subcategories are defined by the European Medicines Agency.

  3. Repeat step 1 for each regulatory activity category that you want to define.
  4. To define the regulatory activity categories used to add and remove products and countries from a submission, follow these steps:
    1. Add or edit this line in the file used to import properties into a page object:

      Regulatory.AddProductCountry.RegulatoryActivityCategory=Initial Submission,Restricted Authorization,Variation

    2. Replace the values with the names, separated by a comma, of the regulatory activity categories your company wants to use to add and remove products and countries from a submission.
  5. If you added any new subcategories to this file, you should also update the RegulatoryStringResource.properties file to allow localization of these terms. The string resources file uses this format for subcategories:

    Regulatory.Range.RegulatoryActivitySubCategory.<VALUE>=<VALUE>

    where <VALUE> is the exact text of a value for the SubCategories property. For example:

    Regulatory.Range.RegulatoryActivitySubCategory.IA=IA

    You need one string resource for each unique subcategory value. Different categories could have the same subcategory value. You only need to define one string resource for that subcategory value.

  6. When finished updating the text file with all properties you want to modify, including the ones shown here, use the text file to modify the Regulatory.properties page object. For more information, see Editing Properties Using MQL.