국가임상시험지원재단

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Government Agency: Ministry of Health and Welfare; Ministry of Food and Drug Safety; Korea Disease Control and Prevention Agency; National Health Insurance Service; Korea Health Industry Development Institute; Health Insurance Review & Assessment Service; Korea Drug Development Fund; National Institute of Health; National Cancer Center; National Institute of Food and Drug Safety Evaluation; Korea Health Information Service

Clinical Trial Center: Cha University Bundang Medical Center; Gachon University Gil Medical Center; The Catholic University Of Korea Seoul St.Mary'S Hospital; Gangnam Severance Hospital; Kyung Hee University Hospital At Gangdong; Konkuk University Medical Center; Kyungpook National University Hospital; Korea University Guro Hospital; Korea University Anam Hospital; Dongguk University Medical Center; Dong-A University Hospital; Bestian Seoul Hospital; Pusan National University Hospital; Seoul National University Bundang Hospital; Samsung Medical Center; Seoul National University Hospital; Asan Medical Center; Severance Hospital; Ajou University Hospital; Yangji Hospital; Wonkwang University Hospital; Ewha Womans University Mokdong Hospital; Inje University Busan Paik Hospital; Inha University Hospital; Chonnam National University Hospital; Jeonbuk National University Hospital; Chungnam National University Hospital; Chungbuk National University Hospital; Ulsan University Hospital; Hallym University Sacred Heart Hospital; Hanyang University Medical Center; Pusan National University Yangsan Hospital

CRO: kolab Health Sciences; PROMEDIS; GSK; D2S; Medical Writing; Synex; SEOUL CRO; SYMYOO; CC&I RESEARCH; C&R RESEARCH; ADM KOREA Inc.; AllLiveC; JNPMEDI; MEDI HELP LINE; BDM Consulting, Inc; LSK Global PS; Caleb Multilab Inc.; IQVIA; CLIPS BnC; PharmaCRO; Linical Korea Co., Ltd.

Analytical CRO/Central LAB: Internationla Scientific Standards; PROMEDIS; GCCL; SML Meditree; Caleb Multilab Inc.

Organization: Korean Research-based Pharma Industry Association; Korea Biomedicine Industry Association; KOREA BIO; Korea Drug Research Association; Korea Pharmaceutical and Bio-Pharma Manufacturers Association
Society/School: Korean Association for the Study of the Liver; The Korean Society of Infectious Diseases; Korean Cancer Association; Korean Academy of Medical Sciences; Korean Cancer Study Group; Innovative Center of Bio-imaging Guided Drug Discovery and Development; The Korean Society of Pharmaceutical Medicine

Information Service: Clinical Research Information Service(Korea Disease Control and Prevention Agency); PHARMA KOREA(Korea Health Industry Development Institute)

Related Agency: (USA) FDA(U.S. Food & Drug Administration); (China) NMPA(National Medical Products Administration); (Europe) EMA(European Medicines Agency); (UK) MHRA(Medicines & Healthcare products Regulatory Agency); (Canada) Health Canada; (Australia) TGA(Therapeutic Goods Administration); (India) CDSCO(Central Drugs Standard Control Organization); (Japan) MHLW(Ministry of Health, Labour, and Welfare); (Japan) PMDA(Pharmaceuticals & Medical Devices Agency); (Singapore) HSA(Health Sciences Authority); (Taiwan) TFDA(Taiwan Food and Drug Administration); (Hong Kong) DO(Drug Office); (Thailand) FDA Thailand; (Vietnam) DAV(Drug Administration of Vietnam); (Indonesia) NA-DFC(Indonesia National Agency of Drug and Food Control); Support Agency; (USA) ACRES(Alliance for Clinical Research Excellence and Safety); (USA) AARHPP(Association for the Accreditation of Human Research Protection Program); (USA) ACRP(Association of Clinical Research Professionals); (USA) CenterWatch; (USA) DIA(Drug Information Association); (USA) NIH(National Institutes of Health); (USA) NCI(National Cancer Institute); (USA) MIT CRITICAL DATA; (USA) TransCelerate; (Europe) ECRIN(European Clinical Research Infrastructure Network); (UK) UKCRC(UK Clinical Research Collaboration); (UK) NIHR(National Institute for Health Research); (Australia) Australian Clinical Trials; (Japan) TRI(Translational Research Informatics Center); (Japan) AMED(Japan Agency for Medical Research and Development); (Singapore) SCRI(Singapore Clinical Research Institute); (Netherlands) IFAPP(International Federation of Associations of Pharmaceutical Physicians); (Saudi Arabia) KAIMRC(King Abdullah International Medical Research Center)

* Criteria for posting CROs: CRO Autonomous Registration Agency

Information Clinical Trials Industry

CLINICAL TRIALS INDUSTRY

4.1 Clinical Trials Industry

(1) Number of CTA approvals

The No. of clinical trials has dramatically increased by 15 times over the past 15 years.
Multinational clinical trials started in 2000 and in 2018, 286 multinational clinical trials were performed, making Korea a rising global clinical trial hub in Asia.

4.2 Clinical Trials Industry-Approval

(1) Number of approvals on SITs and IITs

The No. of SITs increased from 476 cases in 2017 to 505 cases in 2018 (a 6.1% increase from the previous year).
The No. of IITs decreased from 182 cases in 2017 to 174 cases in 2018, showing a 4.4% decrease from the previous year.

4.2 Clinical Trials Industry-Approval

(2) Number of CTA approvals by Phases

The No. of local trials increased to 223 cases (a increase by 21.9% from the previous year). Specifically, the No. of phase 1 local trials increased to 161 cases (a increase by 40.0% from the previous year).

4.2 Clinical Trials Industry-Approval

(3) Number of CTA approvals by Phases

The No. of phase 3 of multinational companies clinical trials had 157 cases in 2018, which was an decrease of 11.8%, from 178 cases in 2017.

4.2 Clinical Trials Industry-Approval

(4) Number of approvals by CTA holders

4.2. Clinical Trials Industry-Approval

(5) Number of CTA approvals by therapeutic areas

The No. of trials on anticancer drugs decreased by 1.6% from the previous year, from 251 cases in 2017 to 247 cases in 2018, but accounted for the highest percent (36.4%) of total clinical trials.

4.2. Clinical Trials Industry-Approval

(6) New drugs Approvals of Biopharmaceuticals

In 2018, the No. of New Chemical Entities(NCE) decreased by 1.7% from 2017, but biopharmaceuticals increased by 9.4% from 2017.

4.2 Clinical Trials Industry-Approval

(7) New drugs Approvals

In 2017, 29 new drugs were approved by the Korean regulatory agency (MFDS).
With strong manpower and potential for success, 31 of new drugs are expected by 2020.

4.2. Clinical Trials Industry-Approval

(8) Approved/Registered Drugs (by therapeutic areas)

In 2017, 2,049 finished medicinal products were approved/registered for clinical trials to Ministry of Food and Drug Safety(MFDS).

Last updated date : 22 July 2019