Overview
Anvisa has recently issued Standard Operating Procedure (SOP) RDC nº 823/2023, launching a pilot project aimed at optimizing the evaluation process based on risk criteria for both medicine registration documentation and post-registration changes.
The primary objective of this initiative is to provide clear guidelines for the assessment and decision-making processes concerning registration requests and modifications to medications. These guidelines are rooted in risk criteria, which evaluate the level of risk associated with proposed medications or changes.
This streamlined approach seeks to enhance efficiency and effectiveness in evaluating medicines, thereby optimizing time and resource allocation throughout the registration and post-registration modification processes. Key aspects include:
- Guidelines: Defined rules and principles governing the evaluation and decision-making process, encompassing document submission requirements, evaluation factors, and pendency management protocols.
- Registration and Modifications: Refers to requests for initial medicine registration and subsequent changes to registered medicines, encompassing alterations in formulation, manufacturing processes, and labeling.
- Risk Criteria: Factors considered during evaluation, including the severity of the treated condition, potential side effects, and the target patient population.
The SOP specifies that these measures will take effect on May 25th, 2027. Additionally, it outlines the roles and responsibilities of managers, specialists, and technicians in evaluating and classifying pending issues based on risk. This structured framework aims to ensure rigorous yet efficient evaluation processes for medicines under regulatory review.
Regulatory Impact
- Top Priority: Yes
- Type of Certificate: Yes
- Spectrum Bands: No
- Import Changes HS Codes: No
- Standard Changes: No
- Product Changes: Yes
- Label Changes: No
Regulatory Impact
| Impact Type | Status |
|---|---|
| Top Priority | |
| Type Certificate | |
| Spectrum Bands | |
| Import Changes (HS Codes) | |
| Standard Changes | |
| Product Changes | |
| Label Changes |