Advanced Regulation Boosts Treatments for Rare Diseases

Anvisa has played a key role in the approval of drugs aimed at rare diseases, achieving a total of 124 approvals in the last eight years. This advance reflects the agency’s commitment to optimizing regulatory processes, ensuring more therapeutic options for patients facing diseases that are often chronic, progressive and disabling.

The Impact of RDC 205/2017 on Drug Approval

One of the main reasons for this significant growth is the implementation of Collegiate Board Resolution (RDC) 205/2017. This regulation established a special procedure for the analysis of drugs intended for rare diseases, allowing greater agility in the processes of:

• Consent to clinical trials;
• Certification of good manufacturing practices;
• Registration of new drugs for treatment, diagnosis and prevention.

Before RDC 205, there was no specific regulation for these drugs, making the process more time-consuming. The new standard balanced the need for speed with technical rigor, ensuring quality, safety and effectiveness.

QR Group’s Role in Regulatory Compliance for Rare Diseases

For international manufacturers looking to insert their products in the Brazilian market, understanding and meeting Anvisa’s requirements is essential. QR Group, a specialist in medical device and drug regulation, offers complete support for companies that want to operate in Brazil. Our technical team assists in the regulatory petition, ensuring that each step is in compliance with current legislation, reducing risks and speeding up approval time.

Advances in Advanced Therapies: The Future of Medicine

In addition to conventional medicines, Anvisa has been dedicated to the regulation of advanced therapies, such as genetic engineering and personalized medicine. These innovative approaches open up new possibilities for treating rare diseases without conventional therapeutic alternatives.

With the exchange of information between international regulatory agencies and the constant training of its teams, Anvisa has improved its regulatory framework to keep up with the advancement of science and ensure increasingly effective and safe treatments.

Anvisa’s regulation has been a determining factor for the advancement of medicine in Brazil, especially in the treatment of rare diseases. If your company needs specialized support to register innovative medicines in the country, QR Group is ready to provide complete advice throughout the regulatory process.

Contact us and ensure that your products meet Anvisa’s requirements quickly and safely.

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