{"id":88306,"date":"2024-04-22T14:35:09","date_gmt":"2024-04-22T17:35:09","guid":{"rendered":"https:\/\/murray.adv.br\/?p=88306"},"modified":"2024-04-22T14:35:11","modified_gmt":"2024-04-22T17:35:11","slug":"pharma-investments-blocked-by-health-regulators-lack-of-analysts","status":"publish","type":"post","link":"https:\/\/murray.adv.br\/en\/pharma-investments-blocked-by-health-regulators-lack-of-analysts\/","title":{"rendered":"Pharma investments blocked by health regulator\u2019s lack of analysts"},"content":{"rendered":"\n<h6 class=\"wp-block-heading has-text-align-center\"><em><strong>ANVISA has about R$6bn in new drugs waiting for analysis and another R$11bn under consideration<\/strong><\/em><\/h6>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p>04\/22\/2024 <\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter is-resized\"><img decoding=\"async\" src=\"https:\/\/s2-valorinternational.glbimg.com\/FXpvklJUOiuT0MDMSuuw7oXjZGI=\/0x0:1000x1077\/984x0\/smart\/filters:strip_icc()\/i.s3.glbimg.com\/v1\/AUTH_37554604729d4b2f9f3eb9ad8a691345\/internal_photos\/bs\/2024\/8\/x\/GjgWInTbAVl4nTuWrKfg\/ricardo-cappelli-gesival-nogueira-kebec-valor.png\" alt=\"Ricardo Cappelli \u2014 Foto: Gesival Nogueira Kebec\/Valor\" style=\"width:494px;height:auto\" \/><\/figure>\n<\/div>\n\n\n<p class=\"has-text-align-center\"><em>Ricardo Cappelli \u2014 Foto: Gesival Nogueira Kebec\/Valor<\/em><\/p>\n\n\n\n<p>The pharmaceutical industry has nearly R$6 billion in potential investments pending analysis by the National Health Surveillance Agency (ANVISA). Another R$11 billion is being analyzed, but there has been no response so far.<\/p>\n\n\n\n<p>The survey was carried out by Grupo FarmaBrasil, the trade association representing companies in the sector. The calculation took into account two factors: requests for approval of medications under review or halted, and the average market value for each category of products.<\/p>\n\n\n\n<p>By categories, R$9.4 billion of the drugs under analysis or awaiting analysis are biological, R$4.1 billion are new and innovative, R$4 billion are generics, R$205 million are non-synthetic, and R$31 million are herbal medicines.<\/p>\n\n\n\n<p>Brazilian Development Bank President Aloizio Mercadante was the first to draw public attention to the issue in February. At the time, he suggested hiring reviewers to speed up the evaluation process. \u201cThere are R$17 billion in investments in ANVISA,\u201d he said at the inauguration ceremony of the president of the Brazilian Agency for Industrial Development (ABDI), Ricardo Cappelli. At the time, Mr. Cappelli also advocated greater \u201cefficiency\u201d of regulatory agencies \u201cto leverage private investments in Brazil.\u201d<\/p>\n\n\n\n<p>Measures such as expanding the number of ANVISA employees are necessary to \u201cgenerate a workflow and regular approval\u201d of medicines in order to offer \u201cpredictability\u201d to the industry, said Adriana Diaf\u00e9ria, vice president of FarmaBrasil. She said the federal government \u201cis committed to strengthening research, technological development, and innovation in the country.\u201d She also sees the public test announced to hire 50 specialists in health regulation and surveillance by ANVISA as positive. \u201cBut it\u2019s not enough to meet all demands,\u201d she said.<\/p>\n\n\n\n<p>In a note, ANVISA also attributes the sluggishness to the lack of employees. \u201cThe long queue periods to which drug candidates are submitted in the country are not the result of inertia of the agency\u2019s managers and employees, but of the number of workers incompatible with the size of the Brazilian drug market,\u201d the regulator said, highlighting \u201cthe drug development and manufacturing capacity of the companies operating in the country.\u201d<\/p>\n\n\n\n<p>ANVISA said that between 2007 and 2023, the number of employees fell to 1,491 from 2,360. Of this group, only 187 work to approve or not drugs. The U.S. Food and Drug Administration (FDA) has 6,815 \u201cemployees with regulatory and authorization skills,\u201d according to ANVISA. Thus, the average time for drug approval is 776 days in Brazil, compared to 245 days in the U.S. The Brazilian queue is also longer than in Japan and Canada (301 days) and Australia (350 days).<\/p>\n\n\n\n<p>Despite the insufficient number of servers, ANVISA \u201chas been adopting mechanisms\u201d to accelerate approvals, \u201cmaintaining the international standard of quality, effectiveness, and safety verification.\u201d Among the measures, it highlights the use of agency evaluations \u201cwith standards and regulatory practices equivalent\u201d to those of ANVISA; joint evaluation with foreign agencies; and implementation of the company\u2019s pre-qualification program, a model similar to that of the Federal Revenue\u2019s Authorized Economic Operator.<\/p>\n\n\n\n<p>In a statement, the Ministry of Management and Innovation in Public Services highlighted that the government will hire 50 specialists in health regulation and surveillance. In addition, at the end of last year, the ministry started a debate with \u201cthe workers of the regulatory agencies, including ANVISA, as part of the negotiation process to handle specific demands of the category.\u201d<\/p>\n\n\n\n<p>*Por Estev\u00e3o Taiar\u00a0\u2014 Bras\u00edlia<\/p>\n\n\n\n<p>Source: Valor International<\/p>\n\n\n\n<figure class=\"wp-block-embed\"><div class=\"wp-block-embed__wrapper\">\nhttps:\/\/valorinternational.globo.com\/\n<\/div><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>ANVISA has about R$6bn in new drugs waiting for analysis and another R$11bn under consideration 04\/22\/2024 Ricardo Cappelli \u2014 Foto: Gesival Nogueira Kebec\/Valor The pharmaceutical industry has nearly R$6 billion in potential investments pending analysis by the National Health Surveillance Agency (ANVISA). Another R$11 billion is being analyzed, but there has been no response so [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[8106],"tags":[24891,24890],"class_list":["post-88306","post","type-post","status-publish","format-standard","hentry","category-murray-news","tag-health-regulators-lack-of-analysts","tag-pharma-investments-blocked"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Pharma investments blocked by health regulator\u2019s lack of analysts - Murray Advogados<\/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:\/\/murray.adv.br\/en\/pharma-investments-blocked-by-health-regulators-lack-of-analysts\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma investments blocked by health regulator\u2019s lack of analysts - Murray Advogados\" \/>\n<meta property=\"og:description\" content=\"ANVISA has about R$6bn in new drugs waiting for analysis and another R$11bn under consideration 04\/22\/2024 Ricardo Cappelli \u2014 Foto: Gesival Nogueira Kebec\/Valor The pharmaceutical industry has nearly R$6 billion in potential investments pending analysis by the National Health Surveillance Agency (ANVISA). Another R$11 billion is being analyzed, but there has been no response so [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/murray.adv.br\/en\/pharma-investments-blocked-by-health-regulators-lack-of-analysts\/\" \/>\n<meta property=\"og:site_name\" content=\"Murray Advogados\" \/>\n<meta property=\"article:published_time\" content=\"2024-04-22T17:35:09+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-04-22T17:35:11+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/s2-valorinternational.glbimg.com\/FXpvklJUOiuT0MDMSuuw7oXjZGI=\/0x0:1000x1077\/984x0\/smart\/filters:strip_icc()\/i.s3.glbimg.com\/v1\/AUTH_37554604729d4b2f9f3eb9ad8a691345\/internal_photos\/bs\/2024\/8\/x\/GjgWInTbAVl4nTuWrKfg\/ricardo-cappelli-gesival-nogueira-kebec-valor.png\" \/>\n<meta name=\"author\" content=\"Gelcy Bueno\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Gelcy Bueno\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/murray.adv.br\/en\/pharma-investments-blocked-by-health-regulators-lack-of-analysts\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/murray.adv.br\/en\/pharma-investments-blocked-by-health-regulators-lack-of-analysts\/\"},\"author\":{\"name\":\"Gelcy Bueno\",\"@id\":\"https:\/\/murray.adv.br\/en\/#\/schema\/person\/dd0d0bea46c2436124555d18c1a0d52e\"},\"headline\":\"Pharma investments blocked by health regulator\u2019s lack of analysts\",\"datePublished\":\"2024-04-22T17:35:09+00:00\",\"dateModified\":\"2024-04-22T17:35:11+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/murray.adv.br\/en\/pharma-investments-blocked-by-health-regulators-lack-of-analysts\/\"},\"wordCount\":588,\"image\":{\"@id\":\"https:\/\/murray.adv.br\/en\/pharma-investments-blocked-by-health-regulators-lack-of-analysts\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/s2-valorinternational.glbimg.com\/FXpvklJUOiuT0MDMSuuw7oXjZGI=\/0x0:1000x1077\/984x0\/smart\/filters:strip_icc()\/i.s3.glbimg.com\/v1\/AUTH_37554604729d4b2f9f3eb9ad8a691345\/internal_photos\/bs\/2024\/8\/x\/GjgWInTbAVl4nTuWrKfg\/ricardo-cappelli-gesival-nogueira-kebec-valor.png\",\"keywords\":[\"health regulator\u2019s lack of analysts\",\"Pharma investments blocked\"],\"articleSection\":[\"Murray News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/murray.adv.br\/en\/pharma-investments-blocked-by-health-regulators-lack-of-analysts\/\",\"url\":\"https:\/\/murray.adv.br\/en\/pharma-investments-blocked-by-health-regulators-lack-of-analysts\/\",\"name\":\"Pharma investments blocked by health regulator\u2019s lack of analysts - 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