{"id":1094,"date":"2025-09-10T11:09:21","date_gmt":"2025-09-10T14:09:21","guid":{"rendered":"https:\/\/www.vitapharmaconsulting.com\/en\/?post_type=noticias&p=1094"},"modified":"2025-09-10T11:09:21","modified_gmt":"2025-09-10T14:09:21","slug":"anvisa-atualizacao-da-rdc-948-2024","status":"publish","type":"noticias","link":"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2025\/09\/10\/anvisa-atualizacao-da-rdc-948-2024\/","title":{"rendered":"ANVISA \u2013 Atualiza\u00e7\u00e3o da RDC 948\/2024"},"content":{"rendered":"

A <\/span>RDC 948\/2024<\/span><\/b>, publicada em dezembro de 2025 como novo marco regulat\u00f3rio para registro de medicamentos de uso humano, j\u00e1 recebeu ajustes importantes que tornam o processo de regulariza\u00e7\u00e3o <\/span>mais direcionado, detalhado e transparente<\/span><\/b>, por meio da publica\u00e7\u00e3o da RDC 991\/2025.<\/span>\u00a0<\/span><\/p>\n

Entre os pontos de atualiza\u00e7\u00e3o, destacam-se:<\/span>\u00a0<\/span><\/p>\n

\ud83d\udccd<\/span> Notifica\u00e7\u00e3o Sanit\u00e1ria<\/span><\/b> \u2013 a avalia\u00e7\u00e3o pr\u00e9via do dossi\u00ea t\u00e9cnico <\/span>pode<\/span><\/b> ser dispensada, e n\u00e3o mais \u00e9 automaticamente dispensada;<\/span>\u00a0<\/span><\/p>\n

\ud83d\udccd<\/span> Nova defini\u00e7\u00e3o de <\/span>rela\u00e7\u00e3o benef\u00edcio\/risco<\/span><\/b>, agora considerada como \u201cpondera\u00e7\u00e3o entre benef\u00edcios-chave, riscos-chave e incertezas relacionadas, com base nos dados apresentados\u201d;<\/span>\u00a0<\/span><\/p>\n

\ud83d\udccd<\/span> Ajuste das classes de medicamentos<\/span><\/b> para fins de regulariza\u00e7\u00e3o junto \u00e0 Anvisa, abrangendo agora todas as classes j\u00e1 definidas anteriormente por regulamenta\u00e7\u00e3o espec\u00edfica da Anvisa: novo, inovador, similar, gen\u00e9rico, fitoter\u00e1pico, espec\u00edfico, dinamizado, g\u00e1s medicinal, biol\u00f3gico, radiof\u00e1rmaco e terapia avan\u00e7ada;<\/span>\u00a0<\/span><\/p>\n

\ud83d\udccd <\/span>Esclarecimento sobre a <\/span>aus\u00eancia de Certificado de Registro de Medicamento (CRM \/ CPP)<\/span><\/b> n\u00e3o impedir a submiss\u00e3o do registro, mas sim a sua <\/span>aprova\u00e7\u00e3o<\/span><\/b>.<\/span>\u00a0<\/span><\/p>\n

\ud83d\udccd<\/span> Detalhamento sobre requisitos de <\/span>CBPF para intermedi\u00e1rios, <\/span><\/b>e uso de <\/span>Dados T\u00e9cnico-Cient\u00edficos (DTC)<\/span><\/b>;<\/span>\u00a0<\/span><\/p>\n

\ud83d\udccd<\/span> Maior especifica\u00e7\u00e3o dos requerimentos para <\/span>as provas de efic\u00e1cia e seguran\u00e7a<\/span><\/b> relacionando-os \u00e0s classes dos medicamentos;<\/span>\u00a0<\/span><\/p>\n

\ud83d\udccd<\/span> Ajuste da denomina\u00e7\u00e3o de <\/span>Parecer P\u00fablico de Avalia\u00e7\u00e3o T\u00e9cnica (PPAT)<\/span><\/b> para <\/span>Parecer P\u00fablico de Avalia\u00e7\u00e3o do Medicamento (PPAM)<\/span><\/b>, com defini\u00e7\u00f5es mais claras sobre sua elabora\u00e7\u00e3o e publica\u00e7\u00e3o.<\/span>\u00a0<\/span><\/p>\n

\ud83d\udd0e<\/span> Essas mudan\u00e7as demonstram que a <\/span>RDC 948\/2024 \u00e9 uma norma din\u00e2mica<\/span><\/b>, que seguir\u00e1 em evolu\u00e7\u00e3o para alinhar o Brasil \u00e0s melhores pr\u00e1ticas regulat\u00f3rias internacionais e para trazer a seguran\u00e7a jur\u00eddica necess\u00e1ria ao processo de regulariza\u00e7\u00e3o de medicamentos no Pa\u00eds, ao mesmo tempo em que refor\u00e7a a necessidade de aten\u00e7\u00e3o cont\u00ednua por parte do setor regulado.<\/span>\u00a0<\/span><\/p>\n

Na <\/span>Vita Pharma Consulting<\/span><\/b>, acompanhamos cada atualiza\u00e7\u00e3o para apoiar nossos clientes na <\/span>interpreta\u00e7\u00e3o estrat\u00e9gica da norma e na implementa\u00e7\u00e3o pr\u00e1tica dos requisitos<\/span><\/b> \u2014 sempre com foco em <\/span>seguran\u00e7a, conformidade e efici\u00eancia<\/span><\/b>.<\/span>\u00a0<\/span><\/p>\n

\ud83d\udccc<\/span> Sua empresa j\u00e1 avaliou como essas altera\u00e7\u00f5es impactam os processos internos de registro?<\/span>
\nEstamos prontos para ajudar a transformar esse desafio em oportunidade.<\/span>\u00a0<\/span><\/p>\n

 <\/p>\n","protected":false},"author":3,"featured_media":1095,"template":"","meta":{"inline_featured_image":false,"_links_to":"","_links_to_target":""},"categorias":[],"yoast_head":"\nANVISA \u2013 Atualiza\u00e7\u00e3o da RDC 948\/2024 - Vita<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2025\/09\/10\/anvisa-atualizacao-da-rdc-948-2024\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ANVISA \u2013 Atualiza\u00e7\u00e3o da RDC 948\/2024 - Vita\" \/>\n<meta property=\"og:description\" content=\"A RDC 948\/2024, publicada em dezembro de 2025 como novo marco regulat\u00f3rio para registro de medicamentos de uso humano, j\u00e1 recebeu ajustes importantes que tornam o processo de regulariza\u00e7\u00e3o mais direcionado, detalhado e transparente, por meio da publica\u00e7\u00e3o da RDC 991\/2025.\u00a0 Entre os pontos de atualiza\u00e7\u00e3o, destacam-se:\u00a0 \ud83d\udccd Notifica\u00e7\u00e3o Sanit\u00e1ria \u2013 a avalia\u00e7\u00e3o pr\u00e9via do... 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