{"id":10578,"date":"2018-11-01T10:29:27","date_gmt":"2018-11-01T09:29:27","guid":{"rendered":"https:\/\/okomeds.com\/?p=10578\/"},"modified":"2020-08-31T20:07:08","modified_gmt":"2020-08-31T18:07:08","slug":"china-becoming-a-new-power-in-pharmaceutical-industry","status":"publish","type":"post","link":"https:\/\/okomeds.com\/es\/china-becoming-a-new-power-in-pharmaceutical-industry\/","title":{"rendered":"China, becoming a new power in pharmaceutical industry"},"content":{"rendered":"<p><a href=\"https:\/\/okomeds.com\/pharma-translation-and-pharmaceutical-business-a-winning-pair\/\" target=\"_blank\" rel=\"noopener noreferrer\">Pharmaceuticals can be developed, used or manufactured in any part of the world.<\/a> China, the world\u2019s second largest pharmaceutical market has become a more mature industry, thanks to the structural adjustment promoted and led by the CFDA (The China Food and Drug Administration). The job to upgrade Chinese pharmaceutical industry and bring Chinese marketed pharmaceutical and device medical products up to international standards has been a constant since 2015.<\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_81 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Alternar tabla de contenidos\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/okomeds.com\/es\/china-becoming-a-new-power-in-pharmaceutical-industry\/#Chinas_more_global_involvement_in_the_pharmaceutical_business\" >China\u2019s more global involvement in the pharmaceutical business<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/okomeds.com\/es\/china-becoming-a-new-power-in-pharmaceutical-industry\/#CFDA_enhancing_drug_quality_in_China\" >CFDA enhancing drug quality in China<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/okomeds.com\/es\/china-becoming-a-new-power-in-pharmaceutical-industry\/#China_encouraging_pharmaceutical_innovation\" >China, encouraging pharmaceutical innovation<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"Chinas_more_global_involvement_in_the_pharmaceutical_business\"><\/span>China\u2019s more global involvement in the pharmaceutical business<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Until then, regulatory policies were not only very challenging for foreign pharmaceutical enterprises, but also for local innovative companies. The reform increased the number of reviewers and optimized the drug registration process, creating a priority <a href=\"https:\/\/okomeds.com\/destruction-of-cancer-drugs-for-increasing-prices-up-4000\/\" target=\"_blank\" rel=\"noopener noreferrer\">review channel for selective drug categories<\/a> (Drug registration acceleration, Opinions on product registration, or Priority approval policy, among others), encouraging new drugs from global pharmaceutical companies to undergo clinical investigation (IND\/NDA for drugs urgently needed or severely short in the market), shortening drug delays, and allowing the foreign drug registration process to be changed from submission to approval (Gx applications, Supplementary applications for changed manufacturing process or technology).<\/p>\n<p>The translation clinical studies and other important pharmaceutical content aids drug manufacturers, scientist, and medical staff to improve treatments and patient health. However, it is essential that the information is properly and correctly translated to avoid problems with any country\u2019s regulatory agency. In this sense, the CFDA has recently issued new translation requirements and instructions for medical devices registration in the Chinese pharmaceutical market.<\/p>\n<p>&nbsp;<\/p>\n\r\n        <a href=\"https:\/\/twitter.com\/intent\/tweet?text=Since 2015 Chinese authorities are bringing Chinese pharmaceutical industry up to international standards.&url=&via=okomeds\" class=\"retweet-okodia\" >Since 2015 Chinese authorities are bringing Chinese pharmaceutical industry up to international standards. <div class=\"retwitear-ok\" style=\"text-align: right;   font-size: 10px; padding-right: 43px;\">Tweet!<\/div><\/a>\r\n        <script>!function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0];if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=\"\/\/platform.twitter.com\/widgets.js\";fjs.parentNode.insertBefore(js,fjs);}}(document,\"script\",\"twitter-wjs\");<\/script>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"CFDA_enhancing_drug_quality_in_China\"><\/span>CFDA enhancing drug quality in China<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>In order to enhance drug quality, requirements will be increased, especially if documentation and translation are increased due to new clinical trials. This not only affects global enterprises but also those settled in China. No translation mistakes are admitted, not only in China but also when exporting Chinese drugs abroad. Pharmaceutical ingredients and their translation, for example, must be double-checked and fines and sanctions art part of the day to day life.<\/p>\n<p><a href=\"https:\/\/okomeds.com\/wellness-a-growing-field-for-medicine-translation\/\" target=\"_blank\" rel=\"noopener noreferrer\">The critical role of medical and pharmaceutical translation <\/a>in the Chinese pharmaceutical industry is becoming increasingly apparent as although needed and useful as an initiative to further screen low-quality drug makers, the requirements of current good manufacturing practice (CGMP) regulations do not solve all possible problems or regulations violations.<\/p>\n<p>Depending on the country a bigger or smaller amount of case forms, questionnaires, data sheets, personal information data or consent forms, need to be translated for the specified country\u2019s regulator. The information must be pristinely translated. Any translation error can cause a denial to market a specific pharmaceutical. But this is not all, as market and sales strategies also need to be carried it out in different languages and not only language but culture al values differ from target audience to target audience and from country to country.<\/p>\n<p>The fact that Chinese people preferred to spend 3 times or more on imported drugs, even if they were the same as domestic drugs, was an important milestone for the Chinese administration to make important changes. Now, the CFDA carries out self \u2013inspections to avoid inaccurate and incomplete clinical data in submissions. Quality Consistency Evaluations for generic drug manufacturers were also started in 2016. Manufacturing processes and quality control are now inspected at provincial-level and sales and marketing processes at city-level FDA.<\/p>\n<p>&nbsp;<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-10583 size-full\" src=\"https:\/\/okomeds.com\/wp-content\/uploads\/2018\/10\/T-J-1.2-4.png\" alt=\"China, encouraging pharmaceutical innovation\" width=\"1024\" height=\"512\" srcset=\"https:\/\/okomeds.com\/wp-content\/uploads\/2018\/10\/T-J-1.2-4.png 1024w, https:\/\/okomeds.com\/wp-content\/uploads\/2018\/10\/T-J-1.2-4-300x150.png 300w, https:\/\/okomeds.com\/wp-content\/uploads\/2018\/10\/T-J-1.2-4-768x384.png 768w, https:\/\/okomeds.com\/wp-content\/uploads\/2018\/10\/T-J-1.2-4-1000x500.png 1000w, https:\/\/okomeds.com\/wp-content\/uploads\/2018\/10\/T-J-1.2-4-700x350.png 700w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/p>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"China_encouraging_pharmaceutical_innovation\"><\/span><strong>China, encouraging pharmaceutical innovation<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Currently, China has a large number of domestic drug manufacturers. Most of them, small to medium size companies which are focused on making generic drugs, including many traditional Chinese medicines. Few manufacturers are actually motivated to invest in innovative new drugs. Some studies point out that about 95% of drugs in China are generic drugs. That is a very different scenery to that of Japan (with 37% innovative drugs), or that of the United States (43% of innovative drugs).<\/p>\n<p>To encourage innovation, the CFDA has also set new policies to change the situation, including prioritizing <a href=\"https:\/\/okomeds.com\/7-drugs-that-changed-the-world\/\" target=\"_blank\" rel=\"noopener noreferrer\">the review and approval process for innovative drugs<\/a>, Issuing separate licenses for holders and manufacturers, encouraging local biotechnology and pharmaceutical research institutes to conduct drug development or protecting innovators\u2019 rights.<\/p>\n<p>Pharmaceutical products must go through a localization process. Otherways, they cannot be relevant in an international market. People in different countries have different thoughts, interests, beliefs, languages or likes, and all these features must be considered when targeting any audience, whether national or foreign. The pharmaceutical future in emerging markets belongs to companies that are able to balance their global competences with custom-made approaches for specific local markets.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Pharmaceuticals can be developed, used or manufactured in any part of the world. China, the world\u2019s second largest pharmaceutical market has become a more mature industry, thanks to the structural adjustment promoted and led by the CFDA (The China Food and Drug Administration). The job&#8230;<\/p>\n","protected":false},"author":1,"featured_media":10582,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[6,620],"tags":[686,687,685,697,192,692,190,690,693,704,698,36,688,699,702,695,703,15,12,42,79,691,665,75,76,705,700,689,701,694,696],"class_list":["post-10578","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-translations","category-pharmaceutical-translations","tag-cfda","tag-cgmp","tag-china","tag-clinical-data","tag-clinical-trials","tag-consent-forms","tag-cro","tag-data-sheets","tag-domestic-drugs","tag-drug-development","tag-drug-manufacturers","tag-drugs","tag-forms","tag-generic-drugs","tag-innovative-drugs","tag-inspections","tag-localization-process","tag-medical-translation","tag-medical-translations","tag-medical-translator","tag-medical-translators","tag-personal-information-data","tag-pharmaceutical-business","tag-pharmaceutical-company","tag-pharmaceutical-industry","tag-protecting-innovators-rights","tag-quality-consistency-evaluations","tag-questionnaires","tag-review-and-approval-process","tag-self-inspections","tag-submissions"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>China, becoming a new power in pharmaceutical industry - Okomeds<\/title>\n<meta name=\"description\" content=\"Pharmaceuticals can be developed, used or manufactured in any part of the world. 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