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Brazilian Regulator Creates New Committee To Take Part In Drug Approvals

Executive Summary

Anvisa’s new committee is expected to improve the drug registration process.

Brazilian drug regulator Anvisa has created a new committee to improve its drug and vaccine registration process by expanding the participation of the scientific community, health service users and civil society groups and involving them in decision making.

The Technical Committee for the Registration of Medicines, (Cateme) was created when Ordinance 875 of 10 August 2023 was published in the Official Journal.

Cateme will carry out technical studies and issue recommendations on drug and vaccine registrations. Its recommendations are to be used as “a source of technical guidance and scientific evidence” to assist in evaluation and decision making processes, says Anvisa.

The committee’s objectives are to:

  • Monitor scientific and technological developments in health surveillance with the aim of modernizing, rationalizing and streamlining Anvisa’s regulatory activities.

  • Promote the participation of the scientific community in health surveillance and regulations and to exchange knowledge and experience.

  • Oversee working groups that will be created at a later date and which will lead discussion on specific themes relating to medicines.

Cateme is made up of ten members who have a three-year mandate. Members include health system user representatives, experts from universities, research institutes and public and private representatives. Members have experience in regulating medicines and biological products, according to Anivsa. External professionals can be invited to work with the committee

The committee also has access to a bank of experts who can be called on to take part in discussions.


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