{"id":87631,"date":"2024-05-17T13:32:27","date_gmt":"2024-05-17T16:32:27","guid":{"rendered":"https:\/\/www.fatosefotosnews.com.br\/anvisa-defende-manutencao-de-marco-regulatorio-para-cannabis-medicinal\/"},"modified":"2024-05-17T13:32:27","modified_gmt":"2024-05-17T16:32:27","slug":"anvisa-defende-manutencao-de-marco-regulatorio-para-cannabis-medicinal","status":"publish","type":"post","link":"https:\/\/www.fatosefotosnews.com.br\/?p=87631","title":{"rendered":"Anvisa defende manuten\u00e7\u00e3o de marco regulat\u00f3rio para cannabis medicinal"},"content":{"rendered":"<p>A diretoria colegiada da Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) aprovou nesta semana um relat\u00f3rio de an\u00e1lise de impacto regulat\u00f3rio sobre produtos de cannabis. O documento trata do cen\u00e1rio regulat\u00f3rio da cannabis para fins medicinais no Brasil e apoia a manuten\u00e7\u00e3o da atual estrat\u00e9gia de autoriza\u00e7\u00e3o desses produtos no pa\u00eds.<img decoding=\"async\" src=\"https:\/\/agenciabrasil.ebc.com.br\/ebc.png?id=1595531&#038;o=node\" style=\"width:1px;height:1px\"><img decoding=\"async\" src=\"https:\/\/agenciabrasil.ebc.com.br\/ebc.gif?id=1595531&#038;o=node\" style=\"width:1px;height:1px\"><\/p>\n<p>A proposta da diretoria colegiada era discutir a manuten\u00e7\u00e3o, o aprimoramento ou a extin\u00e7\u00e3o das regras atuais, que s\u00e3o de dezembro de 2019. Em nota, a Anvisa destacou os principais pontos da vota\u00e7\u00e3o e, consequentemente, do relat\u00f3rio, que apontam necessidade de melhorias na atual resolu\u00e7\u00e3o, mas mant\u00eam o formato de autoriza\u00e7\u00e3o dos produtos:<\/p>\n<ul>\n<li>renova\u00e7\u00e3o da autoriza\u00e7\u00e3o sanit\u00e1ria por mais cinco anos;<\/li>\n<li>amplia\u00e7\u00e3o das vias de administra\u00e7\u00e3o, incluindo \u00e0s vias de administra\u00e7\u00e3o oral e inalat\u00f3ria, por exemplo, a sublingual e a via dermatol\u00f3gica;<\/li>\n<li>previs\u00e3o de tempo para comercializa\u00e7\u00e3o e esgotamento de estoque;<\/li>\n<li>faltam estudos cl\u00ednicos capazes de migrar, no momento, produtos de cannabis para a categoria de medicamentos;<\/li>\n<li>necessidade de a\u00e7\u00f5es, dentro do escopo de atua\u00e7\u00e3o da Anvisa, para ampliar o acesso a produtos medicinais obtidos a partir da cannabis em termos de custo, qualidade e disponibilidade;<\/li>\n<li>desenvolver a\u00e7\u00f5es visando \u00e0 facilita\u00e7\u00e3o das atividades de pesquisa cient\u00edfica, englobando desenvolvimento de produto acabado (forma farmac\u00eautica), desenvolvimento anal\u00edtico, pesquisa pr\u00e9-cl\u00ednica e cl\u00ednica;<\/li>\n<li>promover a\u00e7\u00f5es de divulga\u00e7\u00e3o cient\u00edfica para esclarecimento da popula\u00e7\u00e3o acerca das evid\u00eancias existentes para embasamento do uso racional da cannabis para fins medicinais e dos riscos associados.<\/li>\n<\/ul>\n<h2>Relatora<\/h2>\n<p>Na reuni\u00e3o, a diretora relatora da ag\u00eancia, Meiruze Freitas, tratou de pontos como o cen\u00e1rio nacional e internacional da cannabis, o fornecimento de produtos pelo Sistema \u00danico de Sa\u00fade (SUS), pre\u00e7os, a necessidade de pesquisas e as dificuldades existentes para registrar esses produtos como medicamento.<\/p>\n<blockquote>\n<p>\u201cA avalia\u00e7\u00e3o de impacto regulat\u00f3rio apreciado confirma a import\u00e2ncia da atual regulamenta\u00e7\u00e3o para acesso e desenvolvimento de produtos da cannabis, mas ainda h\u00e1 muito a avan\u00e7ar para apoiar a fabrica\u00e7\u00e3o nacional e o acesso a estes produtos.\u201d<\/p>\n<\/blockquote>\n<p>\u201c\u00c9 preciso ainda maior robustez das informa\u00e7\u00f5es, especialmente com dados cl\u00ednicos ou evid\u00eancias de vida real, de forma a permitir a sua migra\u00e7\u00e3o para a categoria de medicamento\u201d, avaliou a diretora.<\/p>\n<h2>Pr\u00f3ximos passos<\/h2>\n<p>Segundo a Anvisa, o relat\u00f3rio \u00e9 uma etapa de an\u00e1lise de um problema regulat\u00f3rio e de alternativas regulat\u00f3rias, mas, nesta etapa, ainda n\u00e3o h\u00e1 uma proposta objetiva de altera\u00e7\u00f5es na regulamenta\u00e7\u00e3o.<\/p>\n<p>\u201cAs pr\u00f3ximas etapas ser\u00e3o conduzidas pelo diretor Romison Motta, sorteado para ser o relator do processo de revis\u00e3o\u201d, informou a ag\u00eancia.<\/p>\n<p id=\"infocoweb_fonte\" class=\"infocoweb_fonte\">Fonte: <a target=\"_blank\" href=\"https:\/\/agenciabrasil.ebc.com.br\/saude\/noticia\/2024-05\/anvisa-defende-manutencao-de-marco-regulatorio-para-cannabis-medicinal#8ee43150-7d61-488e-b6e8-badde25177a2\" rel=\"noopener\">EBC SA\u00daDE<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A diretoria colegiada da Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) aprovou nesta semana um relat\u00f3rio de an\u00e1lise de impacto regulat\u00f3rio sobre produtos de cannabis. O documento trata do cen\u00e1rio regulat\u00f3rio da cannabis para fins medicinais no Brasil e apoia a manuten\u00e7\u00e3o da atual estrat\u00e9gia de autoriza\u00e7\u00e3o desses produtos no pa\u00eds. A proposta da diretoria colegiada [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":87632,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_angie_page":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_themeisle_gutenberg_block_has_review":false,"page_builder":"","footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[],"tags":[309,3110,1340,5412,3717,3111,8735],"class_list":["post-87631","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","tag-anvisa","tag-cannabis","tag-defende","tag-manuten","tag-marco","tag-medicinal","tag-regulatorio"],"acf":[],"nelio_content":{"autoShareEndMode":"never","automationSources":{"useCustomSentences":false,"customSentences":[]},"efiAlt":"","efiUrl":"","followers":[5],"highlights":[],"isAutoShareEnabled":true,"networkImageIds":[],"permalinkQueryArgs":[],"series":[],"suggestedReferences":[]},"yoast_head":"<!-- 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