The overseas new drugs with urgent clinical needs in China are selected by National Medical Products Administration and National Health Commission. These drugs' MAHs can apply for fast-track marketing approval so that the Center for Drug Evaluation will prioritize the review of the products.
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| SN | Drug Name | Classification | Dosage Form | API/Active Substance | Strength | MAH | First Approved in | First Approved in EU/US/Japan | Therapeutic Domain | Indication | Source |
| 1-37 | view | Chemical Drug | / | Vernakalant hydrochloride | / | Cardiome UK Limited | EU | 2010-09-01 | Cardiovascular and cerebrovascular diseases |
Atrial fibrillation (AF)
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-38 | view | Biological Product | / | Vorapaxar | / | Merck Sharp And Dohme Corp | US | 2014-05-08 | Cardiovascular and cerebrovascular diseases |
Myocardial infarction (MI), peripheral artery disease, thrombosis cardiovascular disease
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-39 | view | Chemical Drug | / | Ledipasvir and sofosbuvir | / | Gilead Sciences Inc | US | 2014-10-10 | Infectious diseases |
Hepatitis C
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-40 | view | Chemical Drug | / | Sofosbuvir, velpatasvir, and voxilaprevir | / | Gilead Sciences Inc | US | 2017-07-18 | Infectious diseases |
Hepatitis C
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |