March 9, 2023 - Santiago, Chile

CPTTP: Pharma and regulatory matters
  by Carey

Chapter 8: Technical Barriers to Trade

This chapter provides rules to facilitate trade by eliminating unnecessary technical barriers, improving transparency, and promoting greater regulatory cooperation. It applies to the elaboration, approval and application of technical regulations, standards, conformity assessment procedures and trade authorization for pharmaceuticals, cosmetics and medical devices. The following points were addressed:

Chapter 18: Intellectual Property

Regarding measures related to pharmaceutical products, this subsection addresses those aspects of the protection and enforcement of intellectual property rights related to undisclosed test data and the marketing of pharmaceutical products.

It should be noted that the parties agreed to suspend several articles of the original TPP. These are those concerning the protection of undisclosed test data or other undisclosed data and biological products. These suspended provisions are not part of the Treaty and the agreement of all CPTPP members would be necessary for these provisions to be applied in the future.

For purposes of this section, a new drug product means a product that does not contain a chemical entity that has been previously approved in that party. The main points addressed are the following:

Chapter 26: Transparency and procedural equity for pharmaceuticals and medical devices:

This section establishes those definitions, principles, and procedures with the goal of ensuring transparency and procedural equity of the relevant aspects of the parties' applicable systems related to pharmaceutical products and medical devices.


[1] A certificate of free sale may also not be required for cosmetics.

[2] Specially Article 18.40°

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