Brazil

Anvisa, the Brazilian health regulatory agency, has published three new guides that provide guidelines for submitting registration requests for new or innovative synthetic and semi-synthetic drugs.

The guides were published on March 27, 2023, and went into effect immediately.

• The first guide provides recommendations for submitting a registration request for a new or innovative synthetic and semi-synthetic drug through the full development route.

View Guide 59 - http://antigo.anvisa.gov.br/documents/10181/5457402/Guia+n%C2%BA+59+vers%C3%A3o+1_20+03+23.pdf/a9608bca-29ac-4e70-af5a-40175b110604

• The second guide provides recommendations for submitting a registration request through the abbreviated development route.

View Guide 60 - http://antigo.anvisa.gov.br/documents/10181/5457402/Guia+n%C2%BA+60+vers%C3%A3o+1_20+03+23.pdf/7c8be04d-4a23-4c77-9239-a0b15dbbd206

• The third guide provides recommendations for submitting a registration request for synthetic, semi-synthetic, and radiopharmaceuticals based on scientific literature.

View Guide 61 - http://antigo.anvisa.gov.br/documents/10181/5457402/Guia+n%C2%BA+61+vers%C3%A3o+1_20+03+23.pdf/b92bc940-d2e3-4dc1-a8a3-1a863ad8a9e3

Anvisa's understanding of the best way to comply with the technical requirements of RDC 753/2022 and other related standards regarding the proof of safety and efficacy of a new or innovative medicine is expressed in the guides. This proof for safety and efficacy is a requirement for granting the registration of a drug, as provided for in Law 6360, of September 23, 1976. RDC 753/2022 updates the definition of development routes, with the differentiation of sources of evidence to prove safety and efficacy.

All submissions, including those based on data from scientific literature, must comply with all technical requirements for proof of safety and efficacy provided for in current regulations. They must also contain all non-clinical and clinical information necessary for assessing the benefit-risk balance of the drug. The recommended format for presenting the documentation remains the Common Technical Document (CTD), in accordance with Guide 24/2019.

The public can make suggestions on the guides through electronic forms, which can be accessed through the link in each guide or on Anvisa's legislation page. Contributions received will be evaluated and may be used to revise the guides and publish new versions of the documents. The deadline for submitting suggestions is September 29, 2023, which is 180 days after the publication of the guides.

New link:

View Legislation - http://antigo.anvisa.gov.br/legislacao#/visualizar/495102