{"id":964,"date":"2020-10-08T14:24:55","date_gmt":"2020-10-08T17:24:55","guid":{"rendered":"https:\/\/www.vitapharmaconsulting.com\/en\/?post_type=noticias&p=964"},"modified":"2022-04-27T14:25:40","modified_gmt":"2022-04-27T17:25:40","slug":"anvisa-questions-answers-on-rdc-359-2020-which-instituted-difa-and-cadifa-for-api-used-in-the-manufacture-of-drug-products","status":"publish","type":"noticias","link":"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2020\/10\/08\/anvisa-questions-answers-on-rdc-359-2020-which-instituted-difa-and-cadifa-for-api-used-in-the-manufacture-of-drug-products\/","title":{"rendered":"ANVISA \u2013 Questions & Answers on RDC 359\/2020, which instituted DIFA and CADIFA for API used in the manufacture of Drug Products"},"content":{"rendered":"

On September 28th,\u00a0ANVISA published\u00a0the document Questions\u00a0&\u00a0Answers\u00a0on\u00a0RDC\u00a0359\/2020, which instituted\u00a0the DIFA (Active Pharmaceutical Ingredient Dossier)\u00a0and\u00a0CADIFA (Letter of Suitability of the Active\u00a0Pharmaceutical Ingredient)\u00a0applicable to active pharmaceutical ingredients (API) used in\u00a0the manufacture of new, innovator, generic and similar drug products.<\/p>\n

The document\u00a0mentioned\u00a0brings the main questions related to the New Regulatory Framework of\u00a0API, published in Brazil on March 2020, which came into force in August 2020.\u00a0See below some important points of discussion in the new Questions\u00a0&\u00a0Answers:<\/p>\n

– General clarifications on DIFA, CADIFA and\u00a0GMP of API issued by ANVISA.<\/p>\n

–\u00a0Information on administrative procedures for CADIFA\u00a0application at\u00a0the ANVISA\u00a0system.<\/p>\n

– Clarification of doubts related to the\u00a0application\u00a0subject\u00a0“Expression of Interest”.<\/p>\n

–\u00a0Details\u00a0about\u00a0documents to be\u00a0submitted\u00a0in Modules 1, 2 and 3 of CTD for CADIFA\u00a0application.<\/p>\n

– Clarifications\u00a0about\u00a0post-marketing authorization changes\u00a0of Active Pharmaceutical\u00a0Ingredients (API)\u00a0and DIFA life cycle\u00a0management.<\/p>\n

– Discussion on the transitional period of the legislation (RDC 359\/2020) and repeal of RDC 57\/2009, and its Normative Instructions (IN 15\/2009 and IN 3\/2013).<\/p>\n

It is also important to mention that the Questions\u00a0&\u00a0Answers was published in Portuguese and English version, and can be accessed through the link:\u00a0\u00a0https:\/\/bit.ly\/34DsuHi<\/a><\/p>\n

\n

Count on Vita to assist your company in developing drug products registration and post-registration projects in Latin America.<\/p>\n

Contact us:\u00a0info@vitaraconsulting.com<\/strong><\/a><\/p>\n","protected":false},"author":1,"featured_media":962,"template":"","meta":{"inline_featured_image":false,"_links_to":"","_links_to_target":""},"categorias":[22],"yoast_head":"\nANVISA \u2013 Questions & Answers on RDC 359\/2020, which instituted DIFA and CADIFA for API used in the manufacture of Drug Products - 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\/2020\/10\/08\/anvisa-questions-answers-on-rdc-359-2020-which-instituted-difa-and-cadifa-for-api-used-in-the-manufacture-of-drug-products\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ANVISA \u2013 Questions & Answers on RDC 359\/2020, which instituted DIFA and CADIFA for API used in the manufacture of Drug Products - Vita\" \/>\n<meta property=\"og:description\" content=\"On September 28th,\u00a0ANVISA published\u00a0the document Questions\u00a0&\u00a0Answers\u00a0on\u00a0RDC\u00a0359\/2020, which instituted\u00a0the DIFA (Active Pharmaceutical Ingredient Dossier)\u00a0and\u00a0CADIFA (Letter of Suitability of the Active\u00a0Pharmaceutical Ingredient)\u00a0applicable to active pharmaceutical ingredients (API) used in\u00a0the manufacture of new, innovator, generic and similar drug products. 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