{"id":18284,"date":"2018-06-28T14:15:38","date_gmt":"2018-06-28T13:15:38","guid":{"rendered":"https:\/\/faus-moliner.com\/en\/novedades-la-regulacion-europea-medicamentos-huerfanos\/"},"modified":"2018-07-11T11:48:22","modified_gmt":"2018-07-11T10:48:22","slug":"changes-on-european-regulations-on-orphan-drugs","status":"publish","type":"post","link":"https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/","title":{"rendered":"Changes on European regulations on orphan drugs"},"content":{"rendered":"

Introduction<\/strong><\/p>\n

The precise and unambiguous definitions of “active substance” and “similar active substance” is essential in the field of medicinal products for rare diseases: the so-called \u201corphan medicinal products\u201d.<\/p>\n

Regulation (EC) 847\/2000, where the definitions of \u201cactive substance\u201d and \u201csimilar active substance\u201d are contemplated, was recently amended by Regulation (EU) 2018\/781, effective as of\u00a0 19 June. Changes introduced by this new Regulation (mainly referring to the definition of “similar active substance” as opposed to “same active substance”) are theoretically limited to the field of rare diseases. However, it is to be noted that the content of such changes may be useful in other fields in which a calm reflection on the terms and scope of the terms \u201cactive substance\u201d and \u201csimilar active substance\u201d is also necessary. This is the case, for example, of the new reference price system for medicines of the National Health System announced by the MoH earlier this year.<\/p>\n

Regulation (EU) 2018\/781<\/p>\n

Two are the main amendments introduced by the new European Regulation which deserve special attention. The first of them is the deletion of the \u201cactive substance\u201d definition contained in Regulation (EC) 847\/2000 which differed from the same term defined in Directive 2001\/83\/EC. Such deletion is due to the fact that the Commission was not empowered to modify, through implementing regulations (such as Regulation (EC) 847\/2000), the legal term of \u201cactive substance\u201d already defined in the above-mentioned Directive. The second relevant amendment is the development and clarification of the term “similar active substance”. In this regard, the new Regulation accurately determines what \u201cprincipal molecular structural features\u201d should mean, which has been the only criterion used so far for the similarity assessment between two active substances.<\/p>\n

Additionally, the new Regulation incorporates an additional criterion to assess similarity between certain kinds of medicines such as advanced therapy medicinal products. This criterion refers to the evaluation of the active substances to be compared on the basis of their biological and functional characteristics.<\/p>\n

New rules regarding the reference price system<\/strong><\/p>\n

Several considerations arise from the new Regulation, which may be useful in connection with the announced amendment of the reference price system in Spain. First, we consider that changes must be addressed carefully to prevent them from altering the current definition of “active substance” which, as this new Regulation reminds us, is a well-established definition of in the Community legislation. Second, the precise definition provided by Regulation (EU) 2018\/781 of “similar active substance”, as opposed to \u201cidentical active substance\u201d, is something that, in our opinion, should be considered by Spanish authorities when defining the term of \u201csame active substance\u201d in the context of the Spanish reference price system.<\/p>\n","protected":false},"excerpt":{"rendered":"

Introduction The precise and unambiguous definitions of “active substance” and “similar active substance” is essential in the field of medicinal products for rare diseases: the so-called \u201corphan medicinal products\u201d. Regulation (EC) 847\/2000, where the definitions of \u201cactive substance\u201d and \u201csimilar active substance\u201d are contemplated, was recently amended by Regulation (EU) 2018\/781, effective as of\u00a0 19… <\/p>\n

<\/div>\n

Read More<\/a><\/p>\n","protected":false},"author":19,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[72,223],"tags":[],"coauthors":[],"class_list":["post-18284","post","type-post","status-publish","format-standard","hentry","category-capsulas-en","category-regulatory-2"],"acf":[],"yoast_head":"\nChanges on European regulations on orphan drugs - Faus Moliner<\/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:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Changes on European regulations on orphan drugs - Faus Moliner\" \/>\n<meta property=\"og:description\" content=\"Introduction The precise and unambiguous definitions of “active substance” and “similar active substance” is essential in the field of medicinal products for rare diseases: the so-called \u201corphan medicinal products\u201d. Regulation (EC) 847\/2000, where the definitions of \u201cactive substance\u201d and \u201csimilar active substance\u201d are contemplated, was recently amended by Regulation (EU) 2018\/781, effective as of\u00a0 19... Read More\" \/>\n<meta property=\"og:url\" content=\"https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/\" \/>\n<meta property=\"og:site_name\" content=\"Faus Moliner\" \/>\n<meta property=\"article:published_time\" content=\"2018-06-28T13:15:38+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2018-07-11T10:48:22+00:00\" \/>\n<meta name=\"author\" content=\"Llu\u00eds Alcover\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Llu\u00eds Alcover\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/\"},\"author\":{\"name\":\"Llu\u00eds Alcover\",\"@id\":\"https:\/\/faus-moliner.com\/en\/#\/schema\/person\/9c887db396e6c9997a6208a40c3e4670\"},\"headline\":\"Changes on European regulations on orphan drugs\",\"datePublished\":\"2018-06-28T13:15:38+00:00\",\"dateModified\":\"2018-07-11T10:48:22+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/\"},\"wordCount\":438,\"publisher\":{\"@id\":\"https:\/\/faus-moliner.com\/en\/#organization\"},\"articleSection\":[\"Capsulas\",\"Regulatory\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/\",\"url\":\"https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/\",\"name\":\"Changes on European regulations on orphan drugs - Faus Moliner\",\"isPartOf\":{\"@id\":\"https:\/\/faus-moliner.com\/en\/#website\"},\"datePublished\":\"2018-06-28T13:15:38+00:00\",\"dateModified\":\"2018-07-11T10:48:22+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Portada\",\"item\":\"https:\/\/faus-moliner.com\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Changes on European regulations on orphan drugs\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/faus-moliner.com\/en\/#website\",\"url\":\"https:\/\/faus-moliner.com\/en\/\",\"name\":\"faus-moliner.com\",\"description\":\"Otro sitio realizado con WordPress\",\"publisher\":{\"@id\":\"https:\/\/faus-moliner.com\/en\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/faus-moliner.com\/en\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/faus-moliner.com\/en\/#organization\",\"name\":\"Faus Moliner\",\"url\":\"https:\/\/faus-moliner.com\/en\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/faus-moliner.com\/en\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/faus-moliner.com\/wp-content\/uploads\/2023\/03\/Logo-FM-web.jpg\",\"contentUrl\":\"https:\/\/faus-moliner.com\/wp-content\/uploads\/2023\/03\/Logo-FM-web.jpg\",\"width\":400,\"height\":283,\"caption\":\"Faus Moliner\"},\"image\":{\"@id\":\"https:\/\/faus-moliner.com\/en\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.linkedin.com\/company\/2372042\/admin\/\"]},{\"@type\":\"Person\",\"@id\":\"https:\/\/faus-moliner.com\/en\/#\/schema\/person\/9c887db396e6c9997a6208a40c3e4670\",\"name\":\"Llu\u00eds Alcover\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/faus-moliner.com\/en\/#\/schema\/person\/image\/7c013ebf5b5f97c6203cfd8a6b59d506\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/dbf0132b5844b926fc2d4f49851ed7a8141b4197ba6d8378277521f451ff89c7?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/dbf0132b5844b926fc2d4f49851ed7a8141b4197ba6d8378277521f451ff89c7?s=96&d=mm&r=g\",\"caption\":\"Llu\u00eds Alcover\"},\"url\":\"https:\/\/faus-moliner.com\/en\/author\/lluis-alcover\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Changes on European regulations on orphan drugs - Faus Moliner","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/","og_locale":"en_US","og_type":"article","og_title":"Changes on European regulations on orphan drugs - Faus Moliner","og_description":"Introduction The precise and unambiguous definitions of “active substance” and “similar active substance” is essential in the field of medicinal products for rare diseases: the so-called \u201corphan medicinal products\u201d. Regulation (EC) 847\/2000, where the definitions of \u201cactive substance\u201d and \u201csimilar active substance\u201d are contemplated, was recently amended by Regulation (EU) 2018\/781, effective as of\u00a0 19... Read More","og_url":"https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/","og_site_name":"Faus Moliner","article_published_time":"2018-06-28T13:15:38+00:00","article_modified_time":"2018-07-11T10:48:22+00:00","author":"Llu\u00eds Alcover","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Llu\u00eds Alcover","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/#article","isPartOf":{"@id":"https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/"},"author":{"name":"Llu\u00eds Alcover","@id":"https:\/\/faus-moliner.com\/en\/#\/schema\/person\/9c887db396e6c9997a6208a40c3e4670"},"headline":"Changes on European regulations on orphan drugs","datePublished":"2018-06-28T13:15:38+00:00","dateModified":"2018-07-11T10:48:22+00:00","mainEntityOfPage":{"@id":"https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/"},"wordCount":438,"publisher":{"@id":"https:\/\/faus-moliner.com\/en\/#organization"},"articleSection":["Capsulas","Regulatory"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/","url":"https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/","name":"Changes on European regulations on orphan drugs - Faus Moliner","isPartOf":{"@id":"https:\/\/faus-moliner.com\/en\/#website"},"datePublished":"2018-06-28T13:15:38+00:00","dateModified":"2018-07-11T10:48:22+00:00","breadcrumb":{"@id":"https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/faus-moliner.com\/en\/changes-on-european-regulations-on-orphan-drugs\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Portada","item":"https:\/\/faus-moliner.com\/en\/"},{"@type":"ListItem","position":2,"name":"Changes on European regulations on orphan drugs"}]},{"@type":"WebSite","@id":"https:\/\/faus-moliner.com\/en\/#website","url":"https:\/\/faus-moliner.com\/en\/","name":"faus-moliner.com","description":"Otro sitio realizado con WordPress","publisher":{"@id":"https:\/\/faus-moliner.com\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/faus-moliner.com\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/faus-moliner.com\/en\/#organization","name":"Faus Moliner","url":"https:\/\/faus-moliner.com\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/faus-moliner.com\/en\/#\/schema\/logo\/image\/","url":"https:\/\/faus-moliner.com\/wp-content\/uploads\/2023\/03\/Logo-FM-web.jpg","contentUrl":"https:\/\/faus-moliner.com\/wp-content\/uploads\/2023\/03\/Logo-FM-web.jpg","width":400,"height":283,"caption":"Faus Moliner"},"image":{"@id":"https:\/\/faus-moliner.com\/en\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/company\/2372042\/admin\/"]},{"@type":"Person","@id":"https:\/\/faus-moliner.com\/en\/#\/schema\/person\/9c887db396e6c9997a6208a40c3e4670","name":"Llu\u00eds Alcover","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/faus-moliner.com\/en\/#\/schema\/person\/image\/7c013ebf5b5f97c6203cfd8a6b59d506","url":"https:\/\/secure.gravatar.com\/avatar\/dbf0132b5844b926fc2d4f49851ed7a8141b4197ba6d8378277521f451ff89c7?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/dbf0132b5844b926fc2d4f49851ed7a8141b4197ba6d8378277521f451ff89c7?s=96&d=mm&r=g","caption":"Llu\u00eds Alcover"},"url":"https:\/\/faus-moliner.com\/en\/author\/lluis-alcover\/"}]}},"_links":{"self":[{"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/posts\/18284","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/users\/19"}],"replies":[{"embeddable":true,"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/comments?post=18284"}],"version-history":[{"count":0,"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/posts\/18284\/revisions"}],"wp:attachment":[{"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/media?parent=18284"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/categories?post=18284"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/tags?post=18284"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/coauthors?post=18284"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}