Overview
The National Health Surveillance Agency (ANVISA) has launched Collegiate Board Resolution, RDC 954/2024 introduces several updates to make the drug registration process more agile and in line with international standards. Among the main points addressed are the digitization of processes, the definition of more objective criteria for granting registrations, harmonization with regulatory standards in other countries and the creation of specific rules for generic and similar drugs. In addition, the standard establishes deadlines and requirements for post-registration updates, ensuring greater security and predictability for companies in the sector.
Introduction
Collegiate Board Resolution (RDC) No. 954/2024, published by the National Health Surveillance Agency (ANVISA), by represents a milestone in the regulation of drug registration in Brazil. With the proposal to modernize and streamline regulatory processes, this rule aims to make the regulatory environment more efficient, reducing deadlines, increasing predictability and facilitating access to new treatments. The changes have a direct impact on the pharmaceutical industry, from the initial submission of documents to the granting of final registration.
Principal aspects of RDC 954/2024
RDC 936/2024 updates and modernizes fundamental aspects of the regulation of health products. The main points include:
Digitization and Agility in Processes:
RDC 954/2024 reinforces the digitalization of drug submission and analysis processes. As a result, companies will be able to use electronic platforms to submit documents, reducing bureaucracy and evaluation deadlines.
New Criteria for Registration:
The rule establishes clearer and more objective criteria for granting registrations, especially for innovative and biological medicines. This includes specific requirements for clinical studies, product safety and efficacy.
Harmonization with International Standards:
Following global trends, the new RDC seeks to bring Brazil into line with guidelines adopted by other regulatory agencies, such as the FDA (USA) and EMA (Europe), facilitating the entry of new medicines into the national market.
Specific Procedures for Generic and Similar Medicines:
New rules have been introduced to speed up the registration of generic and similar medicines, ensuring that these products reach consumers more quickly without compromising quality and safety.
Deadlines and Requirements for Post-Registration Updates:
The resolution also defines new deadlines and requirements for post-registration updates, such as changes in formulation, packaging and labeling, providing more predictability for companies.
Impacts for the Pharmaceutical Industry
Through the implementation of RDC 954/2024, greater efficiency is expected in the approval of medicines in Brazil, benefiting both the industry and patients. The main consequences include:
Reduced approval times: digitalization and harmonization with international standards should speed up regulatory processes.
Greater regulatory predictability: clearer rules guarantee legal certainty for companies.
Easier innovation: innovative medicines can be registered more efficiently, encouraging the development of new therapies.
Faster access to essential medicines: patients will be able to access new therapeutic options in less time.
Conclusion
RDC 954/2024 represents a significant advance in the regulation of medicines in Brazil, bringing more transparency, efficiency and security to the registration process. Companies in the sector must adapt to the new requirements in order to ensure compliance and take advantage of the benefits the standard provides. With this modernization, the country is moving closer to the best international practices, guaranteeing more quality and access to innovative treatments for the population.
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. For the link, click here
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.