{"id":2249,"date":"2020-02-15T21:08:02","date_gmt":"2020-02-15T13:08:02","guid":{"rendered":"https:\/\/credevo.com\/articles\/?p=2249"},"modified":"2024-02-21T17:27:12","modified_gmt":"2024-02-21T09:27:12","slug":"rare-diseases-regulatory-incentives-for-development-of-orphan-drugs-china-india-russia-south-korea","status":"publish","type":"post","link":"https:\/\/credevo.com\/articles\/2020\/02\/15\/rare-diseases-regulatory-incentives-for-development-of-orphan-drugs-china-india-russia-south-korea\/","title":{"rendered":"Rare Diseases: Regulatory Incentives for Development of Orphan Drugs – Asia"},"content":{"rendered":"\n

In recent years, there is a huge leap in the pharma industry towards rare disease research and orphan drug developments due to the great support from regulatory authorities such as faster approval timelines, supportive regulatory frameworks, financial incentives, and many more. Currently, large pharmaceutical companies like Novartis<\/a>, GSK<\/a>, Roche<\/a>, and Pfizer<\/a> are extremely active in the orphan drugs market. Asian country’s regulators have also initiated providing regulatory incentives for the development of orphan drugs.<\/p>\n\n\n\n

\"Regulatory<\/figure>\n\n\n\n

To treat patients with rare diseases and to support the pharma industries that are working on orphan drugs, a supportive regulatory framework was established long back by the regulators in the countries like, USA<\/a> (1983), Japan<\/a> (1993), and Europe<\/a> (2000).<\/p>\n\n\n\n

Check out the first article in this series Rare Diseases: Regulatory Incentives for Development of Orphan Drugs \u2013 US & EU<\/a><\/p><\/blockquote>\n\n\n\n

Now, there is an increasing trend towards orphan drug development worldwide. Many other regulatory authorities are working on coming back with new frameworks to establish great support for orphan drug developments in rare diseases.<\/p>\n\n\n\n

In the previous article series, we have discussed regulatory benefits in the US, Europe, Japan, and Australia, now in this article, we will be looking through the regulatory aspects and new regulatory changes in orphan drugs for rare diseases in the countries like China, India, Russia, and South Korea. <\/p>\n\n\n\n

Check out the second article is this series Rare Diseases: Regulatory Incentives for Development of Orphan Drugs \u2013 Japan & Australia<\/a><\/p><\/blockquote>\n\n\n\n

Regulatory incentives for the development of orphan drugs in China<\/h2>\n\n\n\n

Rare disease definition in China<\/h4>\n\n\n\n

A disease is considered to be rare if the prevalence is <1 patient per 500,000 people or neonatal morbidity of < 1 patient per 10,000 people.<\/p>\n\n\n\n

China is currently suffering from a shortage of treatments for rare diseases. Of the 44 globally available therapies for rare diseases, only 19 are currently available in China. These drugs are priced outreach to the average Chinese patient.<\/p>\n\n\n\n

On May 22, 2018, the new NHC (National Health Commission)<\/strong>, along with the CNDA (China National Drug Administration),<\/strong> and the three other agencies jointly published the first edition of the Rare Disease List (RDL). The RDL<\/strong> includes 121 diseases and is considered a huge milestone for regulation in rare diseases.<\/p>\n\n\n\n

Regulatory benefits for orphan drugs in China<\/h4>\n\n\n\n

In China, there are no proper guidelines and regulations for rare diseases. However, there are some special considerations, such as,<\/p>\n\n\n\n