PHDS HEALTHCARE RESEARCH Co., Ltd.
Broadcast Star participated in the 2017 annual import drug overseas production site inspection briefing held by CFDA.
Release time:
2017-03-17
According to the work deployment of the National Medical Products Administration, the following varieties have been listed as the tasks for the overseas production site inspection of imported drugs in 2017.
2017Announcement of the Annual Import Drug Overseas Production Site Inspection Task (1)
According to the work deployment of the National Medical Products Administration, the following varieties are listed as2017the annual import drug overseas production site inspection tasks. The Center for Food and Drug Review and Inspection of the National Medical Products Administration is responsible for the organization and implementation of related inspections. The on-site inspections are not limited to the following varieties, and any additions will be announced separately.
| Serial Number
|
Variety Name
|
Acceptance Number/Import Registration Certificate Number
|
Company Name
|
Registration Agency
|
Remarks
|
| 1
|
Digitalis Glycosides Eye Drops
|
H20130295
|
Pharma Stulln GmbH
|
Shenzhen Kangzhe Pharmaceutical Co., Ltd.
|
Previous Year's Task Carryover
|
| 2
|
Injectable Arachnoidase α
|
JXSS1500008
|
Genzyme Europe B.V.
|
Sanofi(China)Investment Co., Ltd.
|
Previous Year's Task Carryover
|
| 3
|
Methoxy Polyethylene Glycol Recombinant Human Erythropoietin Injection
|
JXSS1300003
|
Shanghai Roche Pharmaceutical Co., Ltd.
|
Shanghai Roche Pharmaceutical Co., Ltd.
|
Previous Year's Task Carryover
|
| 4
|
Pegylated Interferon α2aInjection
|
S20120048/50
|
Roche Pharma (Schweiz) Ltd.
|
Shanghai Roche Pharmaceutical Co., Ltd.
|
Previous Year's Task Carryover
|
| 5
|
Rituximab Injection
|
JYSB1200281/2/3/4
|
Roche Pharma (Schweiz) Ltd.
|
Shanghai Roche Pharmaceutical Co., Ltd.
|
Previous Year's Task Carryover
|
| 6
|
Recombinant Follicle Stimulating Hormone β Injection
|
JYSB1100190/191/192
|
Merck Sharp & Dohme Limited
|
Merck Sharp & Dohme (China) Co., Ltd.
|
Previous Year's Task Carryover
|
| 7
|
Acetate Ganirelix Injection
|
JXHS1100069
|
N.V. Organon
|
Bermuda Organon (China) Co., Ltd. Beijing Representative Office
|
Previous Year's Task Carryover
|
| 8
|
Hydrochloride Epirubicin Injection
|
H20120389
|
Yibiv Pharmaceutical Co., Ltd.
|
Yibiv Pharmaceutical Co., Ltd.
|
Previous Year's Task Carryover
|
| 9
|
Acetate Triptorelin Injection
|
JYHB1400771
|
Ferring AG
|
Ferring Pharmaceuticals Consulting (Shanghai) Co., Ltd.
|
Previous Year's Task Carryover
|
| 10
|
Hydrochloride Amiodarone Injection
|
H20120497
|
Sanofi-Aventis France
|
Sanofi-Aventis (China) Investment Co., Ltd.
|
Previous Year's Task Carryover
|
| 11
|
Human Albumin
|
S20120070
|
Swiss Jet Bailing Biopharmaceuticals Co., Ltd.
|
Jet Bailing (Shanghai) Pharmaceutical Information Consulting Co., Ltd. Beijing Branch
|
Previous Year's Task Carryover
|
| 12
|
Human Albumin
|
JYSB1200245
|
American Jet Bailing Biopharmaceuticals Co., Ltd.
|
Hangzhou Tigermed Consulting Co., Ltd.
|
|
| 13
|
Injectable Cefoperazone Sodium
|
H20100495
|
Medochemie Ltd.
|
Beijing Boshi Zhixing Pharmaceutical Technology Co., Ltd.
|
|
| 14
|
Fluconazole Capsules
|
H20110496
|
Medochemie Ltd.
|
Beijing Boshi Zhixing Pharmaceutical Technology Co., Ltd.
|
|
| 15
|
Injectable Adenosine Methionine Disulfonate
|
H20140261
|
ABBOTT S.R.L.
|
Abbott Trading (Shanghai) Co., Ltd.
|
|
| 16
|
Hydrochloride Tramadol Sustained Release Tablets
|
H20120382
|
Mundipharma GmbH
|
Mundipharma(China)Pharmaceutical Co., Ltd.
|
|
| 17
|
Decafentanyl Injection
|
H20150237
|
Atlantic Laboratories Corporation, Ltd.
|
Hainan Atlantic Pharmaceutical Factory Co., Ltd.
|
|
| 18
|
Injection of Imipenem and Cilastatin Sodium
|
H20100699
|
Ranbaxy Laboratories Limited
|
Ranbaxy Laboratories Limited Beijing Representative Office
|
|
| 19
|
Human Albumin
|
S20140106
|
Grifols, S.A.
|
Hangzhou Tigermed Consulting Co., Ltd.
|
|
| 20
|
Rituximab Injection (Pre-filled)
|
S20160002
|
Novartis Pharma Schweiz AG
|
Novartis Pharmaceuticals (China) Co., Ltd.
|
|
| 21
|
Glycopyrrolate Inhalation Powder Capsule
|
JXHS1600048
|
Novartis Europharm Limited
|
Novartis Pharmaceuticals (China) Co., Ltd.
|
|
| 22
|
Lurasidone Hydrochloride Tablets
|
JXHS1500114-119
|
Novartis Europharm Limited
|
Novartis Pharmaceuticals (China) Co., Ltd.
|
|
| 23
|
Rabies Vaccine for Human Use (Chicken Embryo Cells)
|
S20150044
|
Chiron Behring Vaccines Private Ltd
|
Beijing Keyuan Xinhai Pharmaceutical Co., Ltd.
|
|
| 24
|
Recombinant Human Coagulation Factor VIII for Injection
|
JYSZ1600013-16
|
Baxter AG
|
Baxter BioScience (Shanghai) Co., Ltd.
|
|
| 25
|
Tigecycline for Injection
|
H20110111
|
Pfizer Limited
|
Wyeth Pharmaceuticals Ltd.
|
|
| 26
|
Indomethacin Vitamin E GelEGel
|
JXHS1500045
|
Imperial Pharmaceuticals Co., Ltd.
|
Beijing Xinyan Pharmaceutical Technology Development Co., Ltd.
|
|
| 27
|
Exenatide Microspheres for Injection
|
JXHS1600049
|
AstraZeneca AB
|
AstraZeneca Investment (China) Co., Ltd.
|
|
| 28
|
Sodium Glucose Conjugate Injection
|
JXHS1600016/17
|
Merck Sharp & Dohme Limited
|
Merck Sharp & Dohme (China) Co., Ltd.
|
|
| 29
|
Saw Palmetto Extract Soft Capsules
|
JYZZ1600008
|
Stada Arzneimittel AG
|
Shanghai Liyi Pharmaceutical Technology Co., Ltd.
|
|
| 30
|
Fumaric Acid Quetiapine
|
JXHS1100082
|
Dr. Reddy's Laboratories Ltd.
|
Sinochem Jiangsu Co., Ltd.
|
|
| 31
|
Olanzapine
|
JXHS1100084
|
NEULAND LABORATORIES LIMITED.
|
Hangzhou Runda Pharmaceutical Technology Co., Ltd.
|
|
| 32
|
Cross-linked Sodium Hyaluronate Injection
|
JXHS1500097
|
Genzyme Biosurgery
|
Sanofi (China) Investment Co., Ltd.
|
|
| 33
|
Ambroxol Hydrochloride
|
JXHS1200014
|
Shilpa Medicare Limited
|
Dalian Zimeng Technology Co., Ltd.
|
|
| 34
|
Zinc Pyrithione Aerosol
|
H20140563
|
Cheminova Internacional S.A.
|
Guangdong Jingyou Nanfang Pharmaceutical Co., Ltd.
|
|
| 35
|
Anti-swelling and Itching Ointment
|
JYZZ1600011
|
Greater East Asia Private Limited
|
Guangdong Detong Pharmaceutical Co., Ltd.
|
|
| 36
|
Compound Menthol Camphor Oil
|
JYZZ1600014
|
Tiger Leopard Pharmaceutical Health Co., Ltd.
|
Guangdong Guojian Pharmaceutical Consulting Co., Ltd.
|
|
| 37
|
Daptomycin for Injection
|
H20150451
|
Cubist Pharmaceuticals, Inc.
|
Merck Sharp & Dohme (China) Co., Ltd.
|
|
| 38
|
Pidotimod Oral Solution
|
JTH1400765/1500021 /1500217/1500371，
H20150635,H20090934
|
POLICHEM S.R.L.
|
Swiss Puli Chemical Industry Company Beijing Representative Office
|
|
| 39
|
Multiple Trace Element Injection
|
H20110522
|
LABORATOIRE AGUETTANT
|
Shanghai Liyi Pharmaceutical Technology Co., Ltd.
|
Keyword:
Relevant regulations and policies
Key points and judgment principles for the quality management of non-clinical research of drugs
In order to standardize the on-site inspection work of Good Laboratory Practice (GLP) for non-clinical drug research and improve inspection quality, the "Key Points and Determination Principles for the Inspection of Good Laboratory Practice in Non-Clinical Drug Research" has been formulated in accordance with relevant requirements such as the "Drug Administration Law of the People's Republic of China," "Good Laboratory Practice for Non-Clinical Drug Research," and "Management Measures for the Certification of Good Laboratory Practice for Non-Clinical Drug Research."
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Technical requirements for the latest declaration data electronic disc
In order to further improve the quality and efficiency of the preparation of electronic application materials for drug registration, and to standardize the management of electronic application materials, our center has updated the "Technical Requirements for Electronic Discs of Application Materials" and "Structure of Electronic Documents for Drug Registration Applications" published on December 2, 2022, based on feedback.
2024-11-22
In December 2023, PHDS HEALTHCARE RESEARCH Co., Ltd. was elected as the vice president unit of the China Food and Drug Enterprise Quality Safety Promotion Association, as well as the vice chairman of its subordinate digital professional committee (Certificate No.: Zhong Shi Yao An Cu Hui Zheng Zi 798). The election and award ceremony took place at the Three Gorges Hospital of Chongqing Medical University.
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On March 26-27, 2024, the China Wuxi Global Oral Forum and the China Food and Drug Promotion Association High-Quality Development Conference, guided by the Wuxi Municipal People's Government and the Wuxi Council for the Promotion of International Trade, and organized by the China Food and Drug Promotion Association and the Oral Health Committee of the China Food and Drug Promotion Association, will be grandly held at the Wuxi International Conference Center.
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