Master Alliance Provisions Guide (MAPGuide)

Regulatory Strategy

This issue focuses on provisions that define who is responsible for making applications for regulatory approvals, as well as how the agreement parties will share information and provide assistance related to the regulatory process. Medical products cannot reach their intended recipients if they do not achieve regulatory approval, and approval processes vary between countries. Detailed regulatory strategies might not be included directly in agreements, but it is important that there are agreement provisions which define the rights and responsibilities of each party in relation to regulatory matters.

Obligations related to obtaining regulatory approvals for certain markets are included under Territory Access Commitments.

Questions to consider when developing regulatory strategy provisions

  • Which party is the sponsor for regulatory applications? 
  • How will the parties coordinate and assist each other in relation to obtaining and maintaining regulatory approvals for the products? 
  • What is the arrangement for safety data sharing and adverse event reporting?

Example approaches found in the MAPGuide

  • Which party is the sponsor for regulatory applications? 
    • Development funding and purchase agreements found in the MAPGuide generally specify that the product developer will be responsible for obtaining regulatory approval.For agreements involving co-development between two or more parties, then one party may be allocated responsibility for regulatory applications, or the responsibility may be split between the parties depending on the territory.
  • How will the parties coordinate and assist each other in relation to obtaining and maintaining regulatory approvals for the products?
    • Some agreements in the MAPGuide, particularly development funding agreements, specify that the funder must be allowed to observe at meetings with regulatory authorities and receive copies of regulatory submissions.
    • Regulatory strategy provisions in co-development and technology transfer agreements often state that the party responsible for regulatory applications will receive reasonable assistance from the other party.
    • Several of the advance purchase agreements in the MAPGuide state that the purchaser (a government or multilateral organization) will provide support for accelerated regulatory approval processes.
  • What is the arrangement for safety data sharing and adverse event reporting?
    • Most of the MAPGuide provisions that address the sharing of safety data state that the product developer must report information related to serious adverse events, and/or related events, such as regulatory non-compliance notifications, to the other party within a specified period of time.