'China approves new drugs after completing trials in China'

Just after completing multi-regional clinical trials within the country

Jessica Liu, Senior Consultant at Tigermed introduces China’s regulatory environment for drug approvals

Korea-China Bio Innovation Forum…country operates an accelerated approval system for rare diseases rather than an orphan drug designation system

The Korea-China Bio Innovation Forum is being held in Hangzhou, China, from the 20th to the 22nd, with 25 Korean bio venture companies participating and meeting with more than 50 Chinese biotech and pharmaceutical companies

China's drug approval authorities grant first-in-class drug approvals to drugs as soon as their multi-regional clinical trials (MRCTs) in China are complete, regardless of whether they are approved by the U.S.

 

Food and Drug Administration (FDA) or other national drug regulatory agencies.

 

Tigermed’s Senior Consultant Jessica Liu responded so to a domestic pharmaceutical company's observation that Korea's Ministry of Food and Drug Safety (MFDS) tends to approve new drugs after referencing the situation of advanced countries, such as whether the U.S.

 

FDA or European EMA approves them.

 

At the Korea-China Bio Innovation Forum hosted by Tigermed and Dream CIS in Xiaoshan, Hangzhou, China, on March 21, Senior Consultant Jessica Liu introduced China's drug approval regulatory policy.

 

According to Liu, China's regulatory authorities have begun working to optimize the new drug IND approval system in 2027.

 

The plan was to shorten the review period for the clinical trial plan from preclinical trials and optimize the review period for new drug approval applications, dividing the required period into 70 days, 130 days, and 200 days according to the approval track for each drug.

 

In particular, China has been operating priority review, breakthrough review, and conditional approval systems for new drugs for which available treatments have been identified that meet the 'unmet medical needs' by targeting serious or life-threatening rare diseases.

 

Korean pharmacuetical and biotech companies attending the forum asked for more details on the Chinese regulatory environment after the presentation.

 

In Korea, first-in-class new drug approvals are granted after the authorities examine the drug’s situation in advanced countries such as the US FDA, and the question of whether the same applies in China attracted the attention of the participants.

 

There were also questions about whether China has an orphan drug designation system like Korea and the United States.

 

Domestic companies want to know if they can take advantage of an incentivized track in the licensing process when introducing treatment for a disease with a very small number of patients into the Chinese market.

 

Jessica Liu, Senior Consultant, Tigermed 

Liu replied that China approves new drugs based on clinical data regardless of their US FDA approval status.

 

While China does not have an orphan drug designation system, it does have criteria for rare disease drugs and an accelerated approval policy.

 

Liu explained, "In China, a new drug application can be submitted and approved as soon as a large-scale multiregional clinical trial is completed in China without the need for FDA or other country’s drug regulatory authorization.

 

In 2017, the regulations were updated to allow imported drugs to conduct Phase I MRCTs, removing the requirement that drugs need registered overseas trials or enter Phase II or Phase III trials.” Liu added, "Although China does not have an orphan drug designation track like in the US, it has published a list of rare diseases in 2018 and 2023, which currently has 207 rare diseases.

 

Although there is no specific patient count threshold like the orphan drug system, rare disease treatments are subject to accelerated approval in China as well.” Meanwhile, the Korea-China Bio Innovation Forum is part of DreamScience's licensed-out new business program, Dream Science, which invites Korean biotech companies and ventures that want to enter China to China for partnership and networking meetings with Chinese pharmaceutical and biotech companies.

 

From the 20th to the 22nd, 25 domestic bio venture companies will participate in the forum and meet with more than 50 local biotech and pharmaceutical companies in China, and will return with information and business information necessary for their expansion into China.