Launched in April 2026 and scheduled to run for one year, the “Strategic APIs for Brazil Project: Innovation, Production, and Future” brings together the Brazilian Association of the Pharmaceutical Inputs Industry (Abiquifi), the Ministry of Health, and the Pan American Health Organization (PAHO), with technical support from the consulting firm Clarivate, to identify which active pharmaceutical ingredients (APIs) deserve strategic attention in the country. The initiative was presented to Abiquifi’s member companies on August 17 and, on September 29, was the subject of an in-person meeting in Brasília to align the criteria for the first stage, the mapping of APIs that are a priority for public health.

How the mapping works

The survey starts from more than 1,500 molecules and combines market, public health, and regulatory criteria: the size of Brazil’s API market, patent status, the essential medicines lists of the World Health Organization (WHO) and of the Ministry of Health, diseases targeted for eradication, products that are a priority for SUS (Brazil’s Unified Health System), litigation-driven demand, supply shortage risks, and the regulatory environment overseen by ANVISA. The expected outcome is a selection of the 50 most strategic APIs for the country’s health.

The work is divided into two fronts. In the first, priority molecules are identified based on public and private consumption. In the second, member companies participate directly to overlay that survey with the production and research and development (R&D) capacity already installed in the country, which makes it possible to compare health needs with what already exists in terms of production capability.

At the meeting at the end of September, the Ministry of Health announced the selection of 140 APIs as part of a preliminary phase. The goal for the next stage is the final selection of 50 APIs. This preliminary analysis highlights a focus on medicinal products used to treat infections, as well as oncological drugs.

At the early September meeting, Abiquifi’s executive president, Norberto Prestes, set out the scope of the initiative: its objective does not start from the premise that Brazil should produce every API, and the work “does not end with a list of APIs, it actually begins with it.” Prioritization seeks to build criteria and evidence to guide future decisions, taking into account health system needs, existing capabilities, and scenarios such as pandemics and geopolitical shifts in global supply chains.

Abiquifi also anticipates that ANVISA may be involved in the upcoming stages. Defining priority APIs could guide the Agency in establishing mechanisms to expedite their review, a move that might encourage companies to invest in the development of the domestic industry. This initiative could be supported by the regulatory framework provided by Law No. 15,471/2026 (the National Health Strategy for the Economic-Industrial Health Complex, ENSCEIS), which classifies APIs as products that can be deemed strategic for health security, productive autonomy, and the sustainability of the Unified Health System (SUS). The regulation of this law by decree is still pending, and the sector is awaiting the establishment of the criteria used to define which products are considered strategic.

Why the topic matters

External dependence on inputs is the backdrop of the initiative. In public statements over recent years, Abiquifi has estimated that Brazil produces about 5% of the APIs it consumes, with most of the remainder imported from China and India, and recalls that in the 1980s domestic production reached approximately 50%. At the August presentation, the association’s executive president described the current dependence as far greater than acceptable for a country with an economy and a population the size of Brazil’s. The COVID-19 pandemic, the period in which the project’s discussions began, exposed the risk of supply interruptions to public health, and Abiquifi points out that the current geopolitical reorganization raises the relevance of the topic.

In this context, the selection of 50 APIs tends to concentrate public policy, funding, and private investment efforts on a limited set of molecules rather than spreading them thin. Antero Macedo, of Clarivate, noted that the list goes beyond a catalog of products, since it points to items capable of moving an entire chain, including from a commercial standpoint for companies.

Regulatory dimension: CADIFA and ANVISA’s public call for applications

At the August meeting, Abiquifi had reported that ANVISA would open a public call for applications, for the participation of regulated companies, aimed at the possible review prioritization of non-associated Letter of Suitability of the Active Pharmaceutical Ingredient Dossier (CADIFA) for national API producers, and that up to six companies may take part in the pilot project. The CADIFA is the Brazilian regulatory instrument through which ANVISA attests that the Drug Master File (called DIFA in Brazil) complies with Brazilian regulations, and the possibility of handling it separately for national producers deserves close attention, since the criteria and format of the pilot depend on what the Agency defines in the call for applications.

In October 2026, ANVISA included the Call for Applications on the agenda of its 20th Ordinary Public Meeting, scheduled for October 29, 2026. The purpose of this call is to facilitate the analysis of up to eight domestically manufactured, non-associated DIFAs.

This movement adds to incentives that already exist in the regulations. Brazilian Resolution RDC No. 1,001/2025, which addresses the classification of applications in the priority category, includes among its prioritization criteria synthetic or semisynthetic medicinal products with all manufacturing steps in the country and with an API produced entirely in national territory, from the introduction of starting materials. The API policy and regulation are therefore moving in the same direction, which reinforces the importance of aligning industrial planning and regulatory strategy.

Expected impacts and points of attention

For national API manufacturers, the priority list tends to serve as a signal for investment and technology development decisions. For companies that formulate medicinal products, the mapping provides input for assessing supply risks and possible opportunities to qualify national sources. For public authorities, the evidence base improves the dialogue among health, science, technology, and production capacity, as Abiquifi itself highlighted. PAHO’s participation also opens the prospect of extending the discussion to other Latin American countries in a second stage.

There are also limits to consider. The project runs for one year, the selection of the 50 APIs is the first stage, and the published materials do not provide details on funding mechanisms or production targets. The feasibility of producing each molecule in the country will depend on cross-checking against installed capacity and on competitiveness against imported inputs, and it is this result that will give the agenda substance.

How Vita can help

For companies that develop, manufacture, or use APIs, following this agenda in a structured way makes a difference in decision-making. Vita supports the preparation, submission, and lifecycle management of API dossiers to ANVISA, under the CADIFA procedure, as well as in Europe, under the Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP) procedure, in addition to supporting projects with other regulatory authorities across Latin America. Vita employs customized strategies that integrate regulatory intelligence and gap analysis to assist companies in recognizing opportunities, anticipating challenges, and outlining feasible regulatory pathways, thereby linking project needs with market prospects.

Companies interested in understanding how the strategic API list may affect their projects can count on Vita.