Center for Food and Drug Inspection of CFDA issued the Announcement on On-site Checking Plan for Drug Clinical Trial Data No. 11 on April 28.

With a plan to carry out on-site checking on the 39 drugs that have been conducted self-inspection and checking of clinical trial data, including Insulin Degludec Injection (acceptance No.: JXSS1500010, JXSS1500011), etc. (see the attachment for the details), the announcement is hereby publicized for 10 working days, from April 28, 2017 to May 12, 2017.
Pharmaceutical products to receive the on-site checking this time are all from foreign pharmaceutical enterprises including Eli Lilly, AstraZeneca and Novo Nordisk, etc.
Attached: Catalog of varieties to be checked the drug clinical trial data on site
|
No. |
Acceptance No. |
Pharmaceutical product name |
Applying unit |
|
1 |
JXSS1500010 |
Insulin Degludec Injection |
Novo Nordisk (China) Pharmaceutical Co., Ltd. |
|
2 |
JXSS1500011 |
Insulin Degludec Injection |
Novo Nordisk (China) Pharmaceutical Co., Ltd. |
|
3 |
JXHS1600020 |
Dabigatran Etexilate Capsules |
Boehringer Ingelheim (China) Investment Co., Ltd. |
|
4 |
JXHL1600143 |
Ombitasvir, Paritaprevir and Ritonavir Tablets |
AbbVie Ltd, Fournier Laboratories Ireland Limited, AbbVie Deutschland GmbH & Co. KG, AbbVie Pharmaceutical Trading (Shanghai) Co., Ltd. |
|
5 |
JXHL1600144 |
Dasabuvir Tablets |
|
|
6 |
CXHS1600012 |
Danoprevir Tablets |
Ascletis Pharmaceuticals Co., Ltd. |
|
7 |
JXHS1700011 |
Sofosbuvir Tablets |
Gilead Sciences International Ltd., Gilead Sciences Ireland UC, Gilead Sciences Hong Kong, S.A.R., China Limited Beijing Representative Office |
|
8 |
JXHL1500248 |
Panobinostat Lactate Capsules |
Beijing Novartis Pharma Co., Ltd. |
|
9 |
JXHL1500249 |
Panobinostat Lactate Capsules |
Beijing Novartis Pharma Co., Ltd. |
|
10 |
JXHL1500250 |
Panobinostat Lactate C... Read More
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