Brazil: Pilot project of optimized assessment for pharmaceutical products

On October 23, 2023, the Brazilian Health Regulatory Agency (Anvisa) published in the Federal Official Gazette (DOU) RDC 823/2023, which establishes the pilot project for implementing the optimized evaluation procedure, based on risk criteria in applications for registration and post-registration changes of medicines. The Resolution comes into force on November 1, 2023. 

The RDC’s draft resulted from a wide-ranging debate at Anvisa, which included 3 public meetings and a Public Consultation (CP No. 1.136/2022), receiving more than 150 contributions. This new regulation is the result of a challenge from Anvisa to reduce the time it takes to analyze petitions, while at the same time allowing for an adequate and precise analysis of each one. 

During her vote, Director Meiruze de Freitas considered the initiative to be the boldest and most innovative for health regulation and for the service of access to medicines, as well as important for the national strategy for the development of the health economic industrial complex, published in September (for more details, please see our material).

With the new standard, the health authority aims to optimize the evaluation process, as well as improve decisions on the suitability of registration and post-registration applications. In this way, these analyses will be better suited to their purpose, which is to guarantee access to products with quality, efficacy, and safety for the population in a reasonable time.

Points of attention

In order to achieve the objectives of the standard, Anvisa has come up with three independent initiatives, but which share the same principle: inserting risk criteria into the evaluations and decisions for the registration and post-registration of medicines, as well as allowing them to undergo an optimized evaluation. They are:

• Qualified sorting: this is an initial analysis to verify admissibility and full compliance with the submission of all documents required for the petition. At this point, any pending cases considered to be high risk will be checked. The idea is that pending issues will be assessed based on their risk, allowing for a 30% reduction in requirements. For example, if there are no medium or high-risk pending issues, the application can be approved, with the following classification “approved with pending issues”. Companies whose petitions are classified as “approved with pending issues” will receive an electronic letter with a deadline for meeting the requirements.
• Product-Specific Guide (GPE): this guide will be of a public nature with the aim of presenting specific guidelines for an optimized evaluation. The GPE will assess the unique risks of each drug, speeding up the analysis. The criteria for inclusion in the GPE are: (i) low-risk ingredients, with a high level of knowledge and experience acquired by Anvisa; (ii) assessment of bioavailability, bioequivalence or other clinical data is not necessary for registration of the drug; (iii) it has a monograph in the Brazilian Pharmacopoeia or in pharmaceutical codes considered admissible by Anvisa under the terms of RDC 511/2021, or any other regulation that may replace it; and (iv) the quality attributes can be sufficiently ensured by means of the controls described in the GPE.
• Pre-Qualification Inspections (IPQ): optional, these are inspections addressing requirements for drug development studies, mainly during the research and development stages. The aim is to verify the consistency of compliance with health regulations by the petitioning companies, so that petitions proposed by them can be evaluated more quickly, without prejudice to a detailed evaluation later. The following companies are eligible:

-Those that have been carrying out drug manufacturing, research and development activities or conducting therapeutic equivalence studies in Brazil for more than 10 years.
-Those that can demonstrate the involvement of the company’s top management in the quality policy; and
-Those that have not been classified as unsatisfactory in another IPQ in the last 24 months.

In practice, petitions will be classified as (a) rejected without requirement, if there is at least one high-risk pending issue; (b) requirement, if there is no high-risk pending issue, but at least one medium-risk pending issue; and (c) approval with pending issues, if there are no medium- or high-risk pending issues. Pending issues are understood as follows:

• Low-risk pending issues: related to formal errors in the process or wording adjustments in the documents submitted, i.e. without significant impacts on the safety, efficacy or quality of the medicine.
• Medium-risk pending issues: those that are not considered to be either low or high risk. There is a moderate degree of complexity.
• High-risk pending issues: those that directly impact the efficacy, safety or quality of a medicine. These are understood to be highly complex and require more time to analyze.

The risk criteria will be defined in a Standard Operating Procedure drawn up by Anvisa in order to standardize the risk classification criteria.

Next steps

Once the new RDC comes into force, optimized procedures will begin to take shape at Anvisa. Initially, only the qualified sorting has the capacity to be applied immediately, as the GPE has yet to be published, and the IPQs will receive a specific schedule, which will consider the descending order of companies with the highest number of registration requests and the inclusion of new concentrations of medicines, as well as the Agency’s own operational capacity.
It is worth noting that this RDC does not apply to biological products, radiopharmaceuticals, blood, tissues, cells, organs and advanced therapy products. However, the technical area is evaluating the expansion to biological products.

The standard undergoes a Regulatory Result Analysis (ARR) as it is a pilot project. The technical area requests 36 months for such an assessment, and DICOL approved 38 months of surveillance for the standard. In other words, the RDC is valid until December 31, 2026.

To find out more details about the topic, contact the Souto Correa Life Sciences & Healthcare team via email lifesciences@soutocorrea.com.br