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The entry into force of CM-CMED Resolution No. 3/2025 on May 29, 2026, will introduce significant changes to pharmaceutical pricing in Brazil, particularly regarding the expansion of the basket of reference countries used by the Drug Market Regulation Chamber (CMED).

Under Article 10 of the new resolution, New Zealand has been removed from the list of international reference countries, while six new countries have been added: South Africa, Germany, Japan, Mexico, Norway, and the United Kingdom.

Among these changes, the inclusion of Japan as a reference country deserves special attention. Although the Japanese pharmaceutical market is one of the largest in the world, its use as a benchmark for price-setting in Brazil may generate significant and potentially adverse impacts for pharmaceutical companies filing Drug Information Dossiers (DIPs) before CMED.

This is because Japan’s pricing system has highly specific characteristics that differ substantially from those of the markets traditionally used as international references.

In Japan, drug prices are heavily regulated by the government and subject to successive mandatory revisions throughout a product’s lifecycle. In addition to the initial price determination by public authorities, the Japanese system provides for periodic mandatory price reductions, particularly for medicines with high sales volumes or those subject to cost-effectiveness assessments.

This discrepancy may create significant distortions in Brazilian pricing. In certain cases, the Japanese price may be substantially lower than prices observed in the other countries within the international reference basket, artificially reducing the benchmark price used by CMED and directly impacting the factory price approved in Brazil.

This is particularly relevant because, under the new resolution, the Factory Price (Preço Fábrica – PF) may not exceed the lowest price applied to the same product among the countries included in the reference basket.

The issue becomes even more relevant considering that Japan’s regulatory framework itself presents unique characteristics that make direct comparisons with other markets difficult. Japan operates under a highly subsidized universal healthcare system, characterized by strong government intervention, centralized price controls, and public policies aimed at containing national healthcare expenditures.

In light of this scenario, pharmaceutical companies may have relevant technical, regulatory, and economic grounds to challenge, within the context of a DIP proceeding, the appropriateness of using Japanese prices in specific cases, particularly where there is a clear discrepancy compared to the other reference countries.

As a result, the strategic assessment of the international reference basket becomes even more important in pricing proceedings before CMED under the new CM-CMED Resolution No. 3/2025.

In this new regulatory environment, the development of robust pricing strategies and the construction of consistent technical and legal arguments become increasingly important for companies seeking to mitigate the impacts arising from the inclusion of Japanese prices in CMED’s international reference basket.

The proper management of the DIP process—including a careful analysis of reference markets, the assessment of regulatory distortions, the development of solid technical, legal, and economic arguments, and direct engagement with CMED on the matter—may prove decisive in determining a medicine’s factory price in Brazil.