TIMELINE

2023

Federal regulatory highlights for Life Sciences & Agribusiness

  • AGRIBUSINESS
  • FOOD
  • MEDICAL DEVICES
  • PHARMA
  • AGRIBUSINESS
  • FOOD
  • MEDICAL DEVICES
  • PHARMA

AGRIBUSINESS

December

Law with the new regulatory framework for the registration, use and commercialization of pesticides is enacted.


November

- Joint Ordinance SDA/MAPA, IBAMA, ANVISA n. 03 /2023 brings specific procedures for the distribution of pending processes for the registration of equivalent technical products, pre-mixes, and formulated products, aiming to meet the four-year deadline for their analysis under the terms of Art. 3 of Decree 10833/2021.


November


- Joint Ordinance SDA/MAPA, IBAMA, ANVISA n. 02 /2023 establishes guidelines for changes in registrations, regarding the inclusions of registered technical product or pre-mix, formulator, handler, and packaging.


November

- The Action Plan for Forest Recovery and Management. + Sustainable Forest Plan is released by the Ministry of agriculture. The plan supports reforestation and forest restoration actions, promotes the sustainable use of forests, stimulates productive chains, in addition to supporting the National Development Plan for Planted Forests and the Forest + Network Forest Connection Initiative. It also supports actions that interact with the Adaptation and Low Carbon Emission Plan in Agriculture (ABS+ 2020/2030) and others such as the Rural Environmental Registry - CAR and Payment for Environmental Services - PSA.


October


- Anvisa published four guides for toxicological evaluation of pesticides on: mutagenic potential, reproductive toxicity, carcinogenic potential, and neurotoxicity. These guides aim to make the criteria for toxicological evaluation even more transparent, especially during the reevaluation process.


September


- Federal government enacts Provisional Ruling 1,186/2023, which supplements Law 12,873/2013 with important tools to ensure that the country effectively addresses phytosanitary or zoosanitary emergencies.


September



- Ministry of Agriculture’s Ordinance establishing new rules on standards for the production, certification, technical responsibility, processing, repackaging, storage, sampling, analysis, marketing, and use of seedlings and propagation material for the exclusive purpose of seedling production.


August


- Supreme Court ruled constitutional provisions of the Biosafety Law (Law 11105/2005) that establish safety standards and oversight mechanisms for activities involving genetically modified organisms (GMOs, or transgenics) and their derivatives.


June


- The Supreme Court ruled constitutional some of the main provisions of Decree 10833/2021 that modified Decree 4074/2002, such as those establishing deadlines for the government authorities to analyze pesticides registration requests


May

- State of Ceará’s law banning aerial application of pesticides is ruled constitutional by the Supreme Court

FOOD

December

Modifications on the sanitary requirements for vegetable oils and fats.


December

Normative Instruction 267/2023 amends Normative Instruction 211/2023, which establishes the technological functions, maximum limits and conditions of use for food additives and technology aids authorized for use in foods.


December

The new regulatory framework for new foods and new ingredients is released by ANVISA, through Resolution RDC 839/2023, which provides for the proof of safety and the authorization of use of new foods and ingredients.


September


- New requirements, criteria, procedures and administrative procedures for the delivery of the annual declaration of production and stocks of beverages, wines and derivatives of grapes and wine and pulp and juice of artisanal fruits established by the Ministry of Agriculture (Ordinance 615/2023).


July


- Ministry of Agriculture issues Ordinance 600/2023, which establishes the requirements and procedures for expertise in the classification of plant products, their by-products and residues of economic value.


May

- ANVISA updates the technical regulation on cellulosic materials, packaging and equipment intended to come into contact with food.

MEDICAL DEVICES

September

ANVISA establishes risk classification, notification and registration regimes, and labeling requirements and instructions for use of in vitro diagnostic medical devices, including their instruments.


September

ANVISA enacts Resolution RDC 837/2023, which provides for the conduct of clinical investigations with medical devices. The objective of the new RDC is to define the procedures and requirements for conducting clinical investigations whose results may support the registration of class III and IV medical devices in Brazil and to define the standards of Good Clinical Practices for the clinical investigations that will support the registration of medical devices.


August

ANVISA allows the importation of medical devices, including their accessories, with manufacturing dates preceding the dates of notification or registration publication, provided that the time lapse does not exceed 5 (five) years, and that such products strictly comply with the conditions of approval with ANVISA.


PHARMA

December

ANVISA approves the amendment on Resolution RDC 47/2009, regarding the requirements for drug labels, allowing skinny labeling in view of patent protection.


October

It aims to enhance the agency’s ability to address complex and unforeseen challenges while promoting the development and adoption of innovative products and services based on new technologies in Brazil. ANVISA now includes innovation among its institutional objectives.


September

To implement the National CEIS Development Strategy, new guidelines are were established in GM/MS Ordinance 1,354, dated September 27, 2023, which also outlines the following programs: Partnerships for Productive Development Program (PDPs); Local Development and Innovation Program (PDIL); Vaccines, Sera, and Blood Derivatives Preparation Program (PPVACSH); Production and Technological Development Program for Neglected Populations and Diseases (PPDN); Modernization and Innovation in Healthcare Program (PMIA); and Infrastructure Expansion and Modernization Program for the Economic-Industrial Health Complex (PDCEIS).


September


Decree 11,714/2023 is was published, addressing the Deliberative Committee and the Technical Evaluation Commission within the Economic-Industrial Health Complex, with the objective of analyzing and evaluating Partnerships for Productive Development (PDPs) and projects stemming from the Local Development and Innovation Program.


September


The National Strategy for the Development of the Economic-Industrial Health Complex (CEIS) is was established by Decree 11,715/2023, with the purpose of guiding public and private investments in health production and innovation sectors.


August

Law 14654/2023 is enacted requiring States and Municipalities to make data on medicinal products in stock of the Brazilian Public Health System (“SUS”) pharmacies accessible in a more user-friendly manner.

April

The Executive Group of the Economic-Industrial Health Complex (GECEIS) is was established by Decree 11,464/2023, to strengthen the domestic production of essential items for the Unified Health System (SUS) and reduce Brazil’s dependency on inputs, medicines, vaccines, and other products. The goal is to reduce SUS´s vulnerability through the development and adoption of health technologies, with a focus on universal access to healthcare.