Understand how ANVISA’s regulation has accelerated the approval of drugs for rare diseases and the impact on international manufacturers.
Health regulation in Brazil has undergone significant advances in recent years. One of the most impacted sectors is medicines for rare diseases, which registered a significant growth in the number of approvals by ANVISA. In the last eight years, 124 new drugs for this type of treatment have been authorized, representing 87% of all approvals made since 2005. This advance is the result of regulatory improvements that have facilitated the entry of new products into the Brazilian market.
Impact of RDC 205/2017 on the Acceleration of Approval Processes
Since 2017, Collegiate Board Resolution (RDC) 205/2017 has been fundamental for the regulation of medicines for rare diseases. Before this rule, there was no specific procedure for these products, which made their approval difficult. The new regulation allowed for flexibility in the requirements, without compromising the quality, safety and efficacy of the medicines.
QR Group, which specializes in regulatory consulting for medical devices and medicines, continuously monitors ANVISA updates and guides international manufacturers on how to meet new requirements. Currently, RDC 205/2017 is under review, which may generate new opportunities and challenges for companies seeking to register innovative products in Brazil.
Expansion of Advanced Therapies in Brazil
Another major regulatory advance is in the standardization of advanced therapy products, which include technologies such as genetic engineering and cell therapy. These treatments hold high promise for rare diseases that, until now, did not have viable therapeutic alternatives. To ensure quality and safety, ANVISA has strengthened regulation, trained its teams and strengthened relations with international reference agencies.
How QR Group Helps International Manufacturers
QR Group has an essential role in supporting companies that want to register medicines and medical devices in Brazil. With expertise in the regulatory sector, the company offers agile and safe solutions to adapt to ANVISA requirements. QR Group also keeps up with changes in regulations to ensure that its customers are always prepared for new regulations and market demands.
If your company is looking for a specialized consultancy for the regularization of health products in Brazil, contact QR Group and ensure compliance and speed in the process.
Source: ANVISA
