Overview
RDC 954/2024 represents a significant advance in the simplification and optimization of the drug registration process with ANVISA. The regulation establishes clear criteria for simplified registration, aiming for greater efficiency and agility for the regulated sector. The blog post will detail the key points of the RDC and the importance of ANVISA’s guidance for the correct application of the new rules, highlighting how GRP Brazil can help companies adapt to this new scenario.
Introduction
The pharmaceutical sector in Brazil is constantly evolving, and the National Health Surveillance Agency (ANVISA) plays a central role in modernizing its processes. Recently, an important milestone was established: the publication of Collegiate Board Resolution (RDC) No. 954/2024, which introduces the New Simplified Drug Registration Regulation.
This new rule is not just an update, but a strategic effort by ANVISA to streamline and optimize the path a drug takes to reach the market. For companies in the sector, correctly understanding and applying the guidelines of RDC 954/2024 is crucial to ensuring agility and success in their registration processes.
The Impact of RDC 954/2024
The quest for a more efficient regulatory process has long been a demand of the sector. RDC 954/2024 emerges as ANVISA’s answer to this need, focusing on bringing clarity and efficiency to drug registration.
The core of this resolution is defining the criteria and conditions under which a drug’s registration can be conducted in a simplified manner. This directly impacts the waiting time and resources companies dedicate to regulatory procedures.
Key Aspects and Opportunities
RDC 954/2024 details several points that warrant companies’ attention. Among the most relevant aspects are:
- Clear Scope Definition: The RDC precisely establishes which types of drugs and under what circumstances the simplified process can be applied. This eliminates ambiguities and allows companies to plan their submissions with greater regulatory certainty.
- Optimized Documentation: The new regulation aims to reduce the complexity and volume of documentation required for registrations falling under the simplified regime. Fewer bureaucratic requirements translate into less time spent on preparation and analysis.
- Increased Agility: The simplification of procedures and the clarity of the rules are primarily aimed at accelerating ANVISA’s evaluation, allowing drugs to reach the population faster, without compromising the standards of safety, quality, and efficacy.
- Focus on Regulated Sector Guidance: ANVISA recognizes that regulatory change requires adaptation and has therefore dedicated efforts to guide the regulated sector on the provisions of RDC 954/2024. Webinars, manuals, and Q&A sessions are essential tools to ensure the correct application of the new rules from the start.
For the regulated sector, this is the time to review and adjust submission strategies. The correct interpretation and application of RDC 954/2024 is the key factor for taking advantage of the simplification benefits.
Conclusion
RDC 954/2024 is a decisive step toward regulatory modernization in Brazil. It not only simplifies processes but strengthens ANVISA’s commitment to efficiency and facilitating access to medicines.
For companies, the main takeaway is the need for in-depth knowledge and immediate compliance with the new rules. GRP Brazil is prepared to be your strategic partner on this journey. Our specialized team closely monitors all ANVISA guidelines and is ready to assist your company in:
- Correctly interpreting the criteria for simplified registration eligibility.
- Reviewing and structuring submission documentation according to the new requirements.
- Ensuring full compliance so you can leverage the agility of RDC 954/2024.
Don’t waste time adapting. Contact GRP Brazil and ensure your drug registration processes are fully aligned with ANVISA’s new and simplified regulation.
GRP Brazil
If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
References
Learn more about Anvisa.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.