11 Drugs in the First Batch, Released in August 2018, Have Already Obtained Marketing Approval!
On 28th March, CDE published a list of “the second batch of overseas new drugs that meet urgent clinical needs (in China)”, there are 30 drugs on the list!
There are 17 Rare Diseases in the second batch
CDE published the list of overseas new drugs that meet urgent clinical needs for the second time, after its very first list on 1st November 2018, which contained 48 overseas new drugs that meet urgent clinical needs.
The second batch primarily focuses on rare disease, among all 30 drugs on the list, 17 of them are drugs for rare disease.
It covers hyperphenylalaninemia, Noonan Syndrome, Prader-Willi Syndrome, X phosphapenic rickets syndrome, type I mucopolysaccharidosis, type II mucopolysaccharidosis, Fabry, hemophilia B, hypercholesterolemia, pulmonary hypertension, Crohn’s disease (CD), multiple sclerosis (MS), Hereditary angioedema, amyotrophic lateral sclerosis(ALS), in total 13 rare diseases.
What drugs can be listed as “overseas new drugs that meet urgent clinical needs?”
The critical criteria are;
1. new drugs for rare diseases that just obtained the marketing approval in the USA, EU or Japan, that are not available in China yet, or
2. new drugs that fulfill the unmet clinical needs for life threatening diseases and/or diseases that have a serious impact on life quality where no current effective treatments are available, or
3. new drugs that show significant clinical advantages in treating these diseases
What is the benefit of being listed as an “overseas new drug that meets urgent clinical needs?”
For new drugs on the list that either have not filed an application or are currently undergoing clinical trials in China, as long as the applicant can provide evidence of no racial/ethnic differences, the applicant can file a marketing approval application immediately by submitting all research data acquired from abroad, along with supporting data of no racial/ethnic differences. If all above criteria are met, the NMPA (previously CFDA) will offer priority review and approval procedures on such applications, and expedite the review and approval process.
11 Drugs in the First Batch Have Already Obtained Marketing Approval
On 8th August 2018, 48 drugs in the first batch were announced for public comment. The NMPA and National Health Commission of People’s Republic of China organized experts to selectively decide on the first list of “the overseas new drugs that meet urgent clinical needs.”
On 1st November 2018, the CDE published the list of “the first batch overseas new drugs that meet urgent clinical needs,” and 8 drugs had obtained approval by the time of the publication!
To date, 11 of the 48 overseas new drugs in the first batch that entered the “special review and approval channel” have obtained marketing approval, including Piperacilli Capsules for late stage breast cancer and Aletinib hydrochloride for NSCLC.
The List of the Second Batch of Overseas New Drugs that Meet Urgent Clinical Needs