Every day, new regulations, regulatory updates, news, and judicial or institutional decisions emerge, all with a direct impact on business operations. To make this monitoring easier, KLA’s Life Sciences and Agribusiness teams have compiled in this newsletter the most relevant topics.
This edition of the Regulatory Updates Bulletin presents the key regulatory developments affecting strategic sectors such as pharmaceuticals, food, supplemental healthcare, pharmaceutical retail, cosmetics, biotechnology, veterinary products, and other products subject to regulation by the Ministry of Agriculture and Livestock (MAPA).
Our goal is to provide clients and partners with a consolidated overview of recent regulatory changes, supporting decision-making and the development of business strategies to address the challenges and seize the new opportunities of the period.
| Authority / Update | Brief description | Who may be impacted |
| National Congress >> Law No. 15,357/2026, published on 03/23/2026 and effective on the same date. | The new law allows the installation of pharmacies and drugstores inside supermarkets, provided they are in segregated spaces and in compliance with sanitary requirements, maintaining the mandatory presence of a pharmacist during all hours of operation and prohibiting the display of medications outside these environments. The standard recognizes the use of digital platforms and e-commerce for logistics and delivery, without transferring sanitary responsibility. It is relevant to monitor this change as it redefines the operation model in pharmaceutical retail and opens new business opportunities at the interface of health, retail, and technology. | Supermarkets, marketplaces, pharmacies and drugstores, digital platforms, pharmaceutical industry, medicine distributors, and pharmaceutical professionals. |
| National Congress >> PL No. 2,142/2025, approved by the CCJ on 03/25/2026. | The PL promotes a structural change in the medicine registration regime by replacing the requirement for registration in the country of origin with a single criterion based on proof of Good Manufacturing Practice (GMP) certification, applicable to domestic and imported products. The measure eliminates dependence on external validations and reduces regulatory asymmetries, but will require a review of sub-legal standards, such as RDC No. 948/2024. The topic deserves attention as it can directly impact the registration processes and the regulatory strategy of companies in the sector. | National and international pharmaceutical industry, importers, distributors, and biotechnology companies. |
| Federal Government / ANTT >> MP No. 1,343/2026, published on 03/19/2026 and effective on the same date | The MP makes the CIOT (Transport Operation Identification Code) mandatory before any freight is carried out, blocking operations that do not comply with the minimum floor, with penalties that can reach R$ 10 million per irregular operation. For regulated sectors, the measure directly impacts the logistics of medicines and pharmaceutical ingredients and agricultural products, potentially generating increased costs and the need to review contracts and operational flows. Attention to the standard is essential to avoid exposure to penalties and ensure the continuity of operations. | Distributors of medicines and ingredients, pharmaceutical industry, importers, logistics operators, and agribusiness companies. |
| ANVISA >> RDC No. 1,018/2026, published on 03/11/2026 and effective on the same date. | This RDC amends RDC No. 977/2025 to include products, plants, and fungi subject to special control among the categories whose importation is prohibited under the Transit Customs and Bonded Warehouse regimes. The measure restricts operational modalities in the foreign trade of this group of products. Monitoring is important to adapt import flows and avoid customs irregularities. | Importers, customs brokers, and companies trading in products, plants, and fungi subject to special control. |
| ANVISA >> Normative Instruction No. 430/2026, published on 03/26/2026 and effective on the same date. | Amends IN No. 106/2021 to update the List of Low-Risk Medicines, subject to notification. | Low-risk medicine industry |
| ANVISA >> Normative Instruction No. 428/2026, published on 03/06/2026 and effective on the same date. | Updates the List of Reference Medicines (LMR), with reflections for manufacturers of reference, generic, and similar medicines. The LMR is the basis for various regulatory and registration processes, making its monitoring essential to maintain compliance and the strategic planning of companies. | Pharmaceutical industry of reference, generic, and similar medicines. |
| ANVISA >> Public Consultation No. 1,384/2026, published on 02/25/2026, open until 04/10/2026 | Anvisa opened a public consultation to review RDC No. 467/2021, which deals with the organization and internal regulations of the collegiate bodies of the Brazilian Pharmacopoeia. This is a concrete opportunity for professionals and entities in the sector to influence the governance of the bodies responsible for defining quality standards and control of medicines in Brazil. Participation is strategic for companies that wish to contribute actively to the regulatory environment. Click here to participate. | Pharmaceutical industry; laboratories; pharmaceutical and regulatory affairs professionals; researchers; members of the Brazilian Pharmacopoeia collegiate bodies; |
| ANVISA >> News – Anvisa starts optimized evaluation of biological products | Anvisa implemented an optimized evaluation model for biological product registrations based on the reliance mechanism, taking advantage of analyses from foreign reference regulatory authorities, without reducing technical rigor. The initiative, provided for in RDC No. 997/2025 and IN No. 289/2024, is part of a plan to reduce the regulatory backlog and speed up analyses. It is a relevant development for companies with ongoing petitions or planning new registrations in this category. | Pharmaceutical industry, biotechnology companies, laboratories producing biological medicines, and regulatory affairs professionals. |
| ANVISA >> News – Petitions related to bioequivalence studies have a new subject code | Anvisa established subject code No. 12413 to standardize the protocol for petitions related to the inclusion and change of the list of administration forms and analytes in relative bioavailability/bioequivalence (BA/BE) and pharmacokinetic studies, as provided for in IN No. 409/2025. Standardization aims to improve the traceability of regulatory processes and is important for companies that need to file this type of petition correctly and promptly. | Pharmaceutical industry; clinical research companies; laboratories; regulatory affairs professionals; |
| ANVISA >> News – System that brings more safety to medical devices in Brazil starts operation | Anvisa started the operation of the Unique Medical Device Identification System (SIUD), as provided for in RDC No. 591/2021 and IN No. 426/2026, with the aim of increasing safety, traceability, and transparency of these products in Brazil. The system allows complete monitoring of devices throughout the entire production chain, from manufacturing to use in the patient, through the Unique Device Identification (UDI). Although data transmission can already be carried out voluntarily, mandatory compliance will be implemented gradually. The initiative aligns the country with the best international practices, strengthens sanitary monitoring, and can boost the competitiveness of the national industry in the global market, in addition to increasing patient safety. | Industry and importers of medical devices, distributors, health professionals, hospitals, and clinics. |
| ANVISA >> Webinar: New Import Process | Our team followed the webinar on registration flows and import consent through DUIMP in the New Import Process (NPI). The model centralizes sanitary analysis in DUIMP, requiring greater precision in the prior registration of information, and may generate delays in release times during the transition period. Understanding the changes in this new flow is essential to avoid operational impacts on imports of regulated products. | Importers, exporters, regulated industry, customs brokers, and logistics operators. |
| ANVISA >> GGALI Sectoral Dialogue | Our team followed the Gerência-Geral de Alimentos (GGALI) sectoral dialogue of ANVISA on the 2026–2027 Regulatory Agenda, which covers strategic themes such as labeling, new foods, plant-based, foods for medical purposes, and contaminants, with strong participation from the sector. However, a longer regulatory horizon is observed, with several initiatives scheduled only for the end of 2027 or beyond. Furthermore, despite the dynamic nature of the agenda, there is no expectation of relevant changes in the short term, especially in themes like “labeling,” which may postpone important adaptations for the industry. | Food industry, manufacturers of packaged foods, plant-based sector, dietary supplements, and labeling industry. |
| CMED >> CMED ORDINANCE No. 7/2026, published on 02/02/2026 and effective from 04/01/2026 | The ordinance updates the list of economic groups used for the calculation of Factor Z, a parameter that defines the annual price adjustment ceiling for medicines. Factor Z can take three levels — 0% (more competitive markets), -1.5%, and -3% (more concentrated markets) — according to the degree of competition in the market. Monitoring is essential as the standard directly impacts the pricing strategy of companies for 2026. | Pharmaceutical industry, laboratories, distributors, pharmaceutical retail, and medicine importers. |
| CMED >> CMED Resolution No. 4/2026, published on 03/31/2026 and effective on the same date. | Establishes the medicine price adjustment limits starting from March 31, 2026 — 3.81% (Level 1), 2.47% (Level 2), and 1.13% (Level 3) — conditioned on the submission of the Marketing Report to CMED; reinforces the mandatory nature of this submission by all registration holders and transparency rules, determining that the disclosed prices do not exceed the values published by CMED on the Anvisa Portal, including the correct disclosure of the PMC considering ICMS variations between states. | Pharmaceutical industry and importers; distributors and wholesalers; pharmacies and drugstores; and, indirectly, health plans, public managers (SUS and secretariats), and consumers. |
| CMED >> CMED Resolution No. 5/2026, published on 03/31/2026 and effective on the same date. | Updates the methodology for calculating the Factory Price (PF) and the Maximum Consumer Price (PMC) of medicines on the CMED Positive List, through conversion factors applied to current prices, considering ICMS rates by state and the incidence of PIS/Pasep and Cofins. The change stems from the new rates for these contributions established by Supplementary Law No. 224/2025. Repeals CM-CMED Resolution No. 2/2024. | Pharmaceutical industry and importers; distributors and wholesalers; pharmacies and drugstores; and, indirectly, health plans, public managers (SUS and secretariats), and consumers. |
| ANS >> ANS NORMATIVE RESOLUTION No. 666/2026, published on 03/16/2026 and effective since 03/16/2026 | The standard regulates technical-assistance visits to health insurance operators to identify serious abnormalities in service delivery, which may result in a requirement for an Assistance Recovery Plan. The measure reinforces the regulatory supervision of the ANS and is relevant as it increases scrutiny of internal processes and the quality of information provided by operators. | Health plan operators, benefit administrators, health service providers, and beneficiaries. |
| ANS >> Public Consultation No. 170/2026, published on 03/25/2026, open until 05/09/2026 | The ANS opened a public consultation to unify and update the rules applicable to contracts between operators and service providers, replacing RNs No. 503/2022 and No. 512/2022. The initiative is a strategic opportunity for regulated agents to contribute to the construction of the new contractual regulatory framework, which tends to directly impact the relationship dynamics between operators and providers. Contributions can be sent within 45 days. Click to participate. | Health plan operators, hospitals, clinics, health professionals, laboratories, and beneficiaries. |
| MAPA >> Public Consultation – SDA/MAPA Ordinance No. 1,559/2026, published on 02/20/2026, open until 04/06/2026 | The ordinance submits for public consultation new rules for the industrial and sanitary inspection of pork and its derivatives, covering facilities, equipment, hygiene, animal welfare, and operational procedures throughout the entire production chain. The modernization of the inspection system seeks to align the country with the best international practices and strengthen sanitary security. Participating in the consultation is relevant for companies that wish to influence the requirements that will impact their operations. Make your contribution. | Slaughterhouse industry, slaughterhouses, pork processors, rural producers, exporters, and sanitary inspection professionals. |
| MAPA >> Public Consultation – SDA/MAPA Ordinance No. 1,560/2026, published on 02/20/2026, open until 04/06/2026 | The ordinance submits for public consultation a proposed technical regulation for the industrial and sanitary inspection of fish and its derivatives, with detailed requirements for facilities, equipment, hygiene, and process control throughout the entire production chain. The initiative seeks to modernize the inspection system and strengthen the competitiveness of the sector in the internal and external markets. Participating in the consultation is an opportunity to contribute to the requirements that will define the regulatory standard for the sector. Contributions can be sent through the official federal government platform. | Fish industry, slaughterhouses, processors, aquaculture producers, fishermen, exporters, and sanitary inspection professionals. |
| INMETRO >> News: Deadline for manufacturers to sell products with the old Inmetro seal ends this Tuesday (03/31) | The article informs that the deadline for manufacturers and importers to sell fire extinguishers, motorcycle helmets, and CNG cylinders with the old Inmetro seal ends on 03/31/2026, starting the final phase of transition to the digital seal. The new model reinforces the traceability and safety of products through features such as QR Code and anti-fraud elements, while distributors and commerce will still be able to sell items with the old seal until 06/30/2026. | Manufacturers and importers of fire extinguishers, motorcycle helmets, and CNG cylinders |
