Resolution RDC 205/2017 in Brazil provides a special mechanism for approving clinical trials, certifying Good Manufacturing Practices (GMP), and registering new drugs for the treatment, diagnosis, and prevention of rare diseases.
What are Rare Diseases in the Brazilian Context?
Rare diseases in Brazil are defined as conditions affecting a small percentage of the population, typically fewer than 65,000 individuals, and they can originate from either genetic or non-genetic factors.
Genetic rare diseases are predominant in Brazil, constituting approximately 80% of the total cases. These conditions are often severe, chronic, and progressive, presenting challenges such as limited resources, inadequate research, and a scarcity of expertise. Non-genetic rare diseases in Brazil lack a clear genetic origin and can result from various factors such as environmental influences, infections, or autoimmune disorders.
According to RDC 205/2017, rare diseases in Brazil impact up to sixty-five (65) people per 100,000, aligning with global standards and underscoring the unique challenges faced by both patients and developers of treatments for rare diseases.
The Role of Resolution RDC 205/2017 in Streamlining the Regulatory Process
The resolution outlines key initiatives for speeding up the Regulatory process for rare disease drugs, which are as follows:
- Clinical trials can be approved without delivering the whole study protocol to the Research Ethics Committee (CEP).
- GMP certification is issued within one hundred and twenty (120) days.
- The initial drug evaluation takes up to sixty (60) days, followed by a thirty (30)-day limit for the response from the sponsor and the final decision by the Agência Nacional de Vigilância Sanitária (ANVISA), which is the Brazilian Health Regulatory Agency.
- Clinical trial authorization is granted within thirty (30) days from the initial evaluation, which is followed by a thirty (30)-day limit for the response from the sponsor, and a forty-five (45)-day limit for the final decision by ANVISA.
Essentially, this resolution seeks to provide transparency, predictability, and flexibility to the Regulatory process for rare disease medicines in Brazil, thereby facilitating patient access to these therapies.
Are you developing a rare disease treatment or exploring opportunities in the Brazilian market? Partnering with an experienced Regulatory service provider such as Freyr can prove invaluable in your journey! Our team of experts will guide you through the nuances of RDC 205/2017 and other relevant regulations, optimizing your product registration process in Brazil. Contact us today!