About Regulatory Context

Each regulatory authority defines its own submission types. For example, the FDA defines 510K submission type. European agencies define these procedures (represented as submission types in Market Registration):

• NP - National Procedure
• MRP - Mutual Recognition Procedure
• CP - Centralized Procedure
• DCP - Decentralized Procedure

The FDA would not accept a submission meeting the NP rules, but both France and Germany would. When applying for market authorization in the European Union, you could apply to the European Medicines Agency (EMA) using the Centralized Procedure, which governs all countries. A country might not have a regulation and could instead accept the market authorization granted by a regulatory authority in another country. As such, a regulatory authority could be associated with countries other than its own.

Regulatory categories are also defined by each regulatory authority. For example, European agencies have defined these categories:

• Drug
• Food supplement
• Biocide
• Cosmetic
• Medical Device

The agency for each country determines the categories for regulatory submissions.

The regulatory authority for a country is the agency tasked with administering regulations for pharmaceuticals and medical devices.

The guidelines for submission depend on the combination of submission type, regulatory category, and regulatory authority. Each regulatory authority has a specific guideline for the submission process for the combination of submission type and regulatory category. You can add the document from the regulatory authority that defines these guidelines to Market Registration, and associate it with a regulatory context (combination of regulatory authority-submission type-regulatory category). Any submission template should be created based on a specific regulatory guideline.

For example, for a European submission, the Regulatory Administrator would create:

• 20 regulatory authority objects (one for the medical regulatory agency in each country)
• 4 submission types: NP, MRP, CP, DCP
• The regulatory categories required for the products developed by the company (could be all 5 of those listed above)

In addition, all of the countries to be associated with the regulatory authorities must be in the active state.

You create a regulatory context by first creating the submission types and regulatory categories, and promote them to the active state. You can create them in the active state, or promote them afterwards. You then create the regulatory authority. Before you can promote the authority to active, you must attach at least one submission type and regulatory category. Then, when you promote the regulatory authority to active, Market Registration automatically creates a regulatory context for each possible combination of regulatory authority/submission type/regulatory context.