Procedure changes for prioritizing registration, post-registration, and prior consent for clinical research of medicines come into force

Published on August 21, Anvisa’s RDC No. 811/2023 comes into force today (September 1, 2023).

The new resolution changed the following rules:

• Anvisa’s RDC No. 204/2017, which sets out the priority category for applications for registration, post-registration, and prior consent for clinical research of medicines; and
• Anvisa’s RDC No. 205/2017, which establishes a special procedure for approval of clinical trials, certification of good manufacturing practices and registration of new drugs for the treatment, diagnosis, or prevention of rare diseases.

As explained in the Reporting Director Daniel Pereira’s vote, the changes aim to solve problems reported by the regulated sector in denials of prioritization requests. The new resolution aims to avoid the:

1. Payment of new fees;
2. Need for a new application for registration or post-registration;
3. Lack of publicity about the reason for the rejection or its lack of relation to the product’s safety and efficacy requirements; and
4. Lack of predictability regarding the time it takes to analyze requests for prioritization.

In this regard, the following points are worth highlighting:

• maintaining the rejection of applications that do not meet the criteria for inclusion in the priority category;
• publication of the rejection reasons; and
• the maximum time limit for rejecting a petition, 45 days. At the end of this period, and in the event of a decision by the technical area that denies the request for inclusion in the priority category, the petition will be sent to the ordinary analysis queue, in a position corresponding to its protocol date. The deadline of 45 days, according to the vote, was defined as one that Anvisa could meet, considering the authority’s staff.

The new resolution is a result of a communication process between the sanitary authority and the regulated sector, which had identified problems with the former rules. With the new regulation, Anvisa plans to end all the identified problems, but its results may be only recognized on a daily practice. The regulated sector must be aware of the new norm’s results, mainly in relation to the clinical research’s deadlines.

As reported by Director Daniel Pereira, there are other themes that cause anxiety in the regulated sector, beyond the rare diseases, such as (i) the possibility of presenting the Term of Commitment for other priority medicines and (ii) the expanding possibility of submitting long-term stability studies for other priority biological medicines.

However, according to the Director, there is a need for further discussion on these issues, as well as the creation of specific regulatory processes.

For further information on this new Resolution, please do not hesitate to contact our Life Sciences & Healthcare team via email: lifesciences@soutocorrea.com.br .