At the beginning of February, the National Health Surveillance Agency (Anvisa) released the Management Report of the General Medicines Management (GGMED)* for 2023.
*GGMED is the area of Anvisa responsible for the regularization of synthetic, semi-synthetic, herbal, specific, potentized medicines and Cannabis products, which guarantees the Brazilian population's access to these medicines with the appropriate quality, safety and effectiveness.
The objective of the document was to present the main results achieved and offer an overview of ongoing and planned activities, in addition to outlining future strategies.
During this period, GGMED faced significant challenges when dealing with remaining demands from the COVID-19 pandemic and when implementing structuring projects, such as the Quality Management System (QMS). The main obstacle faced by the body in meeting the maximum standards of the World Health Organization (WHO) is meeting legal deadlines in analyzing requests for regularization of medicines, resulting from the limitation of the workforce that has deteriorated over the years.
Aiming to improve the performance of its processes and expand its operational capacity in the face of growing demands and finite human resources, the agency implemented actions that resulted in productivity gains, as evidenced by the numbers presented in the report. Among these initiatives, regulatory confidence (known in English as regulatory reliance), the method of evaluating regularization requests based on risk criteria and the publication of a list of qualified impurities stand out. It is worth remembering that the impact of these measures, combined with the implementation of the Quality Management System (QMS) at GGMED, does not manifest itself immediately, but represents a significant future potential for positive results.
RESULTS IN NUMBERS
The numbers reflect GGMED's performance and indicate a positive impact of the recent standards and management measures adopted.
Productivity
The increase in productivity of servers in most units is worth highlighting, even with a lower number of professionals.
The evolution of productivity in the period was measured by the percentage of publications of records (excluding data referring to clones) and authorizations, considering 2017 as the reference year and correcting the number of servers in the units responsible for the analyses. Despite some fluctuations, this indicator reveals a very significant increase in efficiency (figure 1).
Figure 1. Evolution of productivity, considering 2017 as the reference year and correcting the number of servers in the units responsible for the analyses.
Published decisions (approvals and rejections)
There was a significant increase (approximately 36% compared to 2022) in published decisions (approvals and rejections) related to generic, similar, new, innovative, specific, herbal, energized and Cannabis products (excluding clone medicines). Especially if we consider that a task force was not innovative and that there has been a 30% reduction in the workforce since 2017 (figure 2).
Figure 2. Evolution of the number of publications in the period between 2015 and 2023. Note: data referring to clone medicines, due to the more agile and simplified procedure, are excluded from this analysis to avoid bias in the data.
Approval rating
Another highlight was the record approval rate for generics and similar drugs (87.6%) and new and innovative medicines (93.9%) in 2023 (figure 3). These numbers reflect not only the continuous improvement of the regulated sector, but also the positive evolution of the Agency over time, showing an improvement in the quality of the instructions that guide the registration requests submitted.
Figure 3. Percentage of approvals of new and innovative medicines and generic and similar medicines over the years.
However, it is essential to analyze the above data from an additional perspective, noting that approximately 10% of registration requests are still rejected. This indicates that there are medicines being developed inappropriately, which could pose potential health risks to the population.
Approvals
The number of approvals for registration requests for new and innovative medicines, as well as generics and similar drugs, was a record high in 2023 (figure 4).
Figure 4. Number of approvals of generic and similar medicines and new and innovative medicines.
Order flow
The discussion about the volume of incoming and outgoing registration and post-registration requests for synthetic medicines (generic, similar, new and innovative) is also worth highlighting, as the numbers illustrate the difficulty the Agency faces in meeting legal deadlines.
It is clear that the incoming requests exceed the capacity for analysis and decision-making, highlighting the lack of personnel and reinforcing the need for measures and initiatives that give the agency greater agility. (figures 5 and 6).
Figure 5. Number of entries and exits (publications) of registration requests for synthetic and semi-synthetic medicines (generic, similar, new and innovative).
Figure 6. Inputs and outputs of post-registration change petitions for synthetic medicines (new, innovative, generic and similar).
CHALLENGES
Even with the Agency's advances – which there are many –, Anvisa maintains its focus on carrying out its role with increasing efficiency and quality, aware of the challenges involved in regulating medicines.
Therefore, the report highlights the adversities that have long been known and that require an urgent response, such as the pressing need to reduce the analysis deadlines for registration and post-registration processes.
CONCLUSIONS
Society recognizes that Anvisa, through the countless efforts of its entire team, has been improving its performance and that the positive results presented in this report reflect the dedication of the GGMED team. However, there are still relevant issues to be adjusted, especially the need for more human resources and better information technology tools.
Equipped with the necessary apparatus, the agency will be able to contribute to the development of a program of scientific guidance and advice for the national industry, which will result in greater promotion of drug innovation in the country.
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