On August 18, the National Health Surveillance Agency (Anvisa) published Anvisa RDC 811/23, which establishes a new deadline for the technical analysis of priority requests involving drugs.

The new regulation – already in force – amends the Anvisa RDC 204/17, which addresses the rules for classifying petitions for registration, post-registration and prior approval in clinical drug research.

Another amended resolution was Anvisa RDC 205/17, which establishes a special procedure for approving/ clinical trials, certification of good manufacturing practices and registration of new drugs for the treatment, diagnosis or prevention of rare diseases.

Rare diseases are those that affect up to 65 people in every 100,000 individuals, as defined by the National Policy for Comprehensive Care for People with Rare Diseases. This definition is based on official national data or, in the absence thereof, on data published in technical-scientific documentation.

Dismissal of petitions

Anvisa RDC 204/17 stated that the petition would be rejected if the request for inclusion in the priority category was denied during the technical analysis.

The regulated sector, however, pointed out that the reasons for the rejection were not disclosed, as well as there was no forecast on how long it would take to analyze requests for prioritization.

Anvisa’s technical area, in turn, concluded that the possibility of rejection led to a decrease in applications that did not meet the prioritization criteria. The agency also found that the number of rejections recorded in the period from 2017 to 2023 – after the enactment of Anvisa RDC 204/17 and Anvisa RDC 205/17 – is less than 20%.

To avoid an excessive number of requests for prioritization, which would affect productivity and analysis time, Anvisa maintained, in the new resolution, the rejection of petitions that do not meet the criteria for inclusion in the priority category.

However, from now on Anvisa has established a maximum period of 45 days for such rejection, after which it will be sent to the ordinary analysis queue, in the position corresponding to the date on which the request was filed. This deadline change was extended to Anvisa RDC 205/17.

The rule will apply to petitions made after the new resolution comes into force, as well as to requests that had already been made and were still awaiting technical analysis.

Future changes

Anvisa recognized the need for future changes in order to address other issues, including:

  • the possibility of submitting a Term of Commitment for other priority drugs, in addition to rare diseases; and
  • expanding the possibility of submitting long-term stability studies for other priority biological drugs, in addition to rare diseases.

These issues, however, will be addressed in a specific regulatory process.

To learn more, check out our Life Sciences & Healthcare team.