China National Health Commission – Accestra Consulting

Interpretation of the 1st ENCOURAGED GENERIC DRUGS list: why these 34 drugs are selected?

mona.zhang — Wed, 03 Jul 2019 08:41:33 +0000

In June time, the China National Health Commission (NHC) officially announced the draft list of 1^st batch of encouraged generic drugs (details of previous news are accessible he re). There are 34 drugs on this list and it includes a variety of anticancer drugs like Ixabepilone, orphan drugs such as Nitisinone, and drugs that have been in short supply in China market before (e.g., Methotrexate).

However, why are these 34 drugs particularly? Below we have listed the basic information of these drugs, the market situation in China and also the registration progress in China, from which we may understand the reasons why these 34 drugs are selected into the first batch of encouraged generic drugs.

China NHC issued draft list of 1st batch of encouraged generic drugs

mona.zhang — Sun, 30 Jun 2019 07:47:42 +0000

On June 20^th, China National Health Commission (NHC) officially announced the draft list of 1^st batch of encouraged generic drugs (NHC is a ministry-level institute of the State Council, in which the Department of Drug Policy and Essential Medicine takes the responsibility of improving the national essential medicine system and establishing national drug policies and Essential Drug Catalogue). There are a total of 34 drugs in this drafted list, including drugs came off patent (or are about to expire) in China but no MA application is submitted, and drugs in short supply in clinical.

The release of this list is considered as the follow-up of two previous important documents on generic drugs supply issued by China authority in 2018, one of which is the “Opinions on Reforming and Improving the Supply and Protection Policy of Generic Drugs” by the General Office of the State Council, and the other is the “Notice of Printing and Distributing the Work Plan for Accelerating the Implementation of Generic Drugs Supply Guarantee Policy” issued by NHC and other 12 ministries. In these two documents, it is proposed that China will regularly publish lists of encouraged generic drugs: before the end of June 2019, the first list will be released; from year 2020 onwards, such list will be released at the end of each year. And according to the “Notice”, for drugs in these encouraged lists, the priority review and approval pathway shall be applicable in the process of MA application to China NMPA.

So far it’s the 1^st batch of list issued by China NHC, and the publicity time is 5 working days. However, the corresponding favorable policy details for the listed drugs have not been announced yet.

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