{"id":14494,"date":"2015-02-16T10:55:06","date_gmt":"2015-02-16T16:55:06","guid":{"rendered":"http:\/\/www.salud.carlosslim.org\/english2\/?p=14494"},"modified":"2015-02-18T19:14:34","modified_gmt":"2015-02-19T01:14:34","slug":"new-regulation-to-approve-biopharmaceuticals-comes-into-force","status":"publish","type":"post","link":"http:\/\/www.salud.carlosslim.org\/english2\/new-regulation-to-approve-biopharmaceuticals-comes-into-force\/","title":{"rendered":"New regulation to approve biopharmaceuticals comes into force"},"content":{"rendered":"

\"biopharmaceuticals\"In the early twentieth century, the development of scientific research was able to double the life expectancy using antibiotics and vaccines<\/strong>. Now mankind is on the verge of reaching an age of over 100 years with the use of biopharmaceuticals<\/strong>, which have greater therapeutic capacity over conventional drugs for the management of serious illnesses such as cancer<\/strong>, heart disease<\/strong>, arthritis<\/strong> and diabetes<\/strong>, among others.<\/p>\n

Biopharmaceuticals<\/strong> are medical drugs produced using biotechnology<\/strong>. These drugs are directly extracted from a non-engineered biological source<\/strong> in contrast to chemical-origin drugs commonly used. These drugs have extensive and complex molecular structure as well as an also complex production and storage.<\/p>\n

With the appearance of such drugs, it has been possible to treat, control and cure diseases that could not have been treated with drugs of chemical origin. In fact, it is estimated that more than 250 million patients worldwide have benefited from 350 biotech drugs developed so far<\/strong>.<\/p>\n

The entry into force of the amendment to the Official Mexican Standard (NOM) 257, aimed to approve third-generation biopharmaceuticals, has positioned Mexico at the forefront in Latin America. In a statement, the Ministry of Health stated that with this action, the country became the first nation “in having a modern and clear legal framework for authorizations of biopharmaceuticals and biosimilars”<\/em>.<\/p>\n

The head of the Federal Commission for Protection against Health Risks (COFEPRIS), Mikel Arriola Pe\u00f1alosa, said that this is an advanced regulatory reform that will allow bringing to Mexican patients the newer drugs discovered in first world countries. The Commissioner added that Mexico completed this regulation in order to reinforce Mexicans access to the most advanced therapies and innovative third-generation biopharmaceuticals.<\/p>\n

Arriola said that the registration of new biopharmaceuticals<\/strong> will be promoted, without foreclosing products currently marketed in Mexico. Also, he said, the NOM 257 establishes the criteria that the COFEPRIS will use for the biopharmaceuticals’ regulation; as well as it institutes the requirements for manufacturing control, the procedure for approval of clinical protocols, and specifications to establish the reference medicinal product.<\/p>\n

The NOM 257 clearly organizes and establishes the process by which new registration and extensions of drugs applications will be addressed, with the sole intention of sticking to what is mandated by Congress, he said.<\/p>\n

Mikel Arriola said that prior to applying for registration, all biopharmaceutical must be approved by the Committee on New Molecules and the Biopharmaceuticals Evaluation Subcommittee. That, he said, has the purpose to determine whether there are technical elements to demonstrate its safety, quality and efficacy.<\/p>\n

Likewise, he concluded, all biosimilars must demonstrate biosimilarity studies and complete tests and undergo the drug-monitoring processes.<\/p>\n

Source: <\/strong>Notimex<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

In the early twentieth century, the development of scientific research was able to double the life expectancy using antibiotics and vaccines. Now mankind is on the verge of reaching an age of over 100 years with the use of biopharmaceuticals, which have greater therapeutic capacity over conventional drugs for the management of serious illnesses such …<\/p>\n","protected":false},"author":1,"featured_media":14496,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"ngg_post_thumbnail":0,"footnotes":""},"categories":[3],"tags":[15],"class_list":["post-14494","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualidad-en-la-salud","tag-casalud","cat-3-id","has_thumb"],"_links":{"self":[{"href":"http:\/\/www.salud.carlosslim.org\/english2\/wp-json\/wp\/v2\/posts\/14494","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/www.salud.carlosslim.org\/english2\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/www.salud.carlosslim.org\/english2\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/www.salud.carlosslim.org\/english2\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.salud.carlosslim.org\/english2\/wp-json\/wp\/v2\/comments?post=14494"}],"version-history":[{"count":4,"href":"http:\/\/www.salud.carlosslim.org\/english2\/wp-json\/wp\/v2\/posts\/14494\/revisions"}],"predecessor-version":[{"id":14514,"href":"http:\/\/www.salud.carlosslim.org\/english2\/wp-json\/wp\/v2\/posts\/14494\/revisions\/14514"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/www.salud.carlosslim.org\/english2\/wp-json\/wp\/v2\/media\/14496"}],"wp:attachment":[{"href":"http:\/\/www.salud.carlosslim.org\/english2\/wp-json\/wp\/v2\/media?parent=14494"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/www.salud.carlosslim.org\/english2\/wp-json\/wp\/v2\/categories?post=14494"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/www.salud.carlosslim.org\/english2\/wp-json\/wp\/v2\/tags?post=14494"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}