{"id":949,"date":"2021-04-14T17:11:45","date_gmt":"2021-04-14T20:11:45","guid":{"rendered":"https:\/\/www.vitapharmaconsulting.com\/en\/?post_type=noticias&p=949"},"modified":"2022-04-28T15:38:08","modified_gmt":"2022-04-28T18:38:08","slug":"whitepaper-differences-between-cadifa-letter-of-suitability-of-the-active-pharmaceutical-ingredient-anvisa-and-cep-certificate-of-suitability-edqm","status":"publish","type":"noticias","link":"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2021\/04\/14\/whitepaper-differences-between-cadifa-letter-of-suitability-of-the-active-pharmaceutical-ingredient-anvisa-and-cep-certificate-of-suitability-edqm\/","title":{"rendered":"Whitepaper – Differences between CADIFA (Letter of Suitability of the Active Pharmaceutical Ingredient) – ANVISA and CEP (Certificate of Suitability) – EDQM"},"content":{"rendered":"
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In April 2021, the New Regulatory Framework for APIs in Brazil completed one year since its publication. These regulations were published after a long period of discussion between the Agency and the regulated sector. With these regulations, the CADIFA (Letter of Suitability of the Active Pharmaceutical Ingredient) was created.<\/p>\n

Much is discussed about the similarity between CADIFA and CEP (Certificate of Suitability), issued in the European Union because the Brazilian regulation was based on the European regulatory model and both documents attest to the quality of the API marketed.<\/p>\n

So, we have prepared our new whitepaper, which aims to discuss the main similarities and differences related to regulatory aspects for the submission and approval of CADIFA and CEP and presenting a comparison on the content of the dossier that must be presented in the application for both certificates.<\/p>\n

But after all, what is a whitepaper?<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

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It is nothing more than a material with more in-depth content on a given subject. Warning: it is not a scientific article.<\/p>\n

We have prepared this document by consulting the legislation and through searching for available information at ANVISA\u2019s and EDQM\u2019s websites, in order to identify the main points of similarity and difference for both certificates.<\/p>\n

If you are already a subscriber to the Vita\u2019s Newsletter, you must have already received the document. If it is not yet, and if you want to have access to the whitepaper, just request it using the form below, thus subscribing to our newsletter, and the file will be immediately available for download.<\/p>\n

See you soon!<\/p>\n<\/div>\n<\/div>\n","protected":false},"author":1,"featured_media":950,"template":"","meta":{"inline_featured_image":false,"_links_to":"","_links_to_target":""},"categorias":[22,24],"yoast_head":"\nWhitepaper - Differences between CADIFA (Letter of Suitability of the Active Pharmaceutical Ingredient) - ANVISA and CEP (Certificate of Suitability) - EDQM - 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\/2021\/04\/14\/whitepaper-differences-between-cadifa-letter-of-suitability-of-the-active-pharmaceutical-ingredient-anvisa-and-cep-certificate-of-suitability-edqm\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Whitepaper - Differences between CADIFA (Letter of Suitability of the Active Pharmaceutical Ingredient) - ANVISA and CEP (Certificate of Suitability) - EDQM - Vita\" \/>\n<meta property=\"og:description\" content=\"In April 2021, the New Regulatory Framework for APIs in Brazil completed one year since its publication. 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