rare disease – Accestra Consulting

Is the publication of China’s first national rare diseases list a new opportunity for global Pharmaceutical Companies?

lynn.huang — Fri, 19 Apr 2019 08:09:17 +0000

In May, 2018, Chinese government published the first rare disease national list, the list contains 121 diseases which published by China National Health Commission in together with other four Chinese government agencies. Although there is not yet a definition of rare disease in China, this first list contains Albinism, Hemophilia, Neonatal Diabetes Mellitus are all disease found with common characteristics of chronic, progressive, diverse symptoms which severely affect patient’s life quality.

Although the number of Chinese first rare diseases list is small comparing with the over 7,000 rare diseases recognized globally, consider the large overall population in China, total patient number that suffered from the listed rare disease cannot be underestimated. Researchers estimate there are at least 16.8 million Chinese with rare diseases.

With the continual publication of the rare diseases catalogue by Chinese government, positive gains will be made with increasing funds and efforts in the field of clinical and science research, also it is predicable that more overseas clinical-valued drugs, effective and affordable treatments will be available for patients with rare diseases.

Please click the link at the end to download the whole list .

First National Rare Diseases List in China

China releases Draft “urgently needed” drugs list (2nd batch)for Fast Track, Accelerated Approval, Priority Review

lynn.huang — Sat, 13 Apr 2019 03:26:27 +0000

On March 28^th, China Center for Drug Evaluation (CDE) released an “urgently needed” new drugs list for fast track, accelerated approval, priority review which contains a list of 30 overseas country approved new drugs. This list mainly refers to new drugs for the treatment of rare diseases and for the prevention and treatment of diseases that seriously endanger life or seriously affect quality of life, which have been existingly approved by US FDA, the European Union or Japanese drug authorities but have not been listed in China in recent years; drugs that are not yet available in China with no effective treatment or new drugs with obvious clinical significance. On August 8^th year 2018, CDE published the first batch list of 48 new drugs that were approved overseas as the urgently needed in China.

Last year, Chinese state council executive meeting has proposed to fast track and grant accelerated approval of the urgently needed new drugs in China. In October 31th, 2018, National medical products administration (NMPA) issued an notice (No. 79), published “The review and approval process for urgent clinical needs foreign drug” which jointly work with National Health Commission of the People’s Republic of China. Priority review and a special evaluation channels will be established to fast track review and approve new drugs that are urgently needed. Those on the list and classified as rare disease drugs and other new drugs aims to gain China drug approval within 3 months and 6 months respectively. Please see the list below for your reference.

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Another New Tax Cut of China Pharmaceuticals

troy — Wed, 06 Mar 2019 02:02:57 +0000

Since March 1^st, 2019, China will reduce taxes on rare disease drugs: the importation is taxed at 3% reduced rate, and the domestic production, wholesale and retail can adopt 3% rate according to the simple calculation method. The first tax-reduction rare diseases list includes 21 drug preparations such as Bosentam Tablets, Iloprost solution for inhalation and Pirfenidone Capsules, plus 4 APIs including Bosentan, Pirfenidone, Penicillamine and Riluzole. This list of rare disease drugs will be jointly updated by the China Ministry of Finance, General Administration of Customs, State Taxation Administration and National Medical Products Administration.

The above-mentioned tax reduction notice was issued by Ministry of Finance, which is the implementation of the tax reduction decision made at the State Council executive meeting held on February 11^th, 2019. In addition to the tax reduction for rare disease drugs, it’s also proposed on the meeting that the registration approval of new anti-cancer drugs should be accelerated in China to benefit the early market entry of new drugs in China, besides, more anti-cancer drugs should be added into national medical insurance.

The tax reduction of rare disease drugs this time is another tax benefit in the pharmaceutical field since 2018, when the tax of anti-cancer drugs was cut. The continuous tax reduction trend of drugs can be predicted and it is expected that there will be more health care field related tax reductions in the near future.