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Accumulated assignments to resolve when getting clinical studies done in China

For difficulties to conduct clinical studies in China, people picked: devaluation of clinical studies at hospitals, financial opacity and immaturity of the IRB review process. At the KOREA PHARM & BIO 2018 on the 18t...

Available to designate orphan drugs only with approval of clinical trial plan

On the 18th, the Ministry of Food and Drug Safety(MFDS) pre-announced a revision bill to the ‘Regulations for Orphan Drug Designation’ which contains articles of improving regulations which allows health care authorit...

‘Evaluation Track for Cutting-Edge Medical Technology’ will be adopted early next year

The Ministry of Health and Welfare will adopt a special evaluation track for potential cutting-edge metical technologies, such as artificial intelligence, 3D printing and robots, to quickly enter market. The current ...

Governments to ignore 5-year-old administrative measures for innovative pharma certificate

The government ruled out administrative measures imposed within the last 5 years(based on judgement date) as a criterion for revocation of the innovative pharmaceutical company certificate. Data and documents for app...

How come health insurance benefits cut by illegal rebates never recover?

It was argued that health insurance benefits that are cut off due to illegal rebate should recover in a certain time. It was criticized it was too hard for pharmaceutical companies because there is no regulations to r...

59% of members in KPA were women pharmacists

While the ratio of women pharmacists is getting higher and higher, 59% of members in the Korea Pharmaceutical Association(KPA) reportedly were female pharmacists. According to the Korea Pharmaceutical Association Sta...

Daegu Gyeongbuk Medical Innovation Foundation to develop drugs and medical devices with body fats

Daegu Gyeongbuk Medical Innovation Foundation(hereinafter referring to DGMIF, acting Chairman Gyu-Ho Song) has opened a new path to develop pharmaceutical products and medical devices using disposed body fats after a ...

Health functional food business owners pay KRW 13.81 million fine at most

The Ministry of Food and Drug Safety(MFDS) will enforce the ‘Enforcement Ordinance of the Health Functional Food Act’ containing articles about increasing fines and imposing standards for people or parties violating t...

Ilyang Pharmaceutical’s Parkinson’s disease drug candidate ‘Supect’ stated in international SCI journal

Ilyang Pharmaceutical(CEO Dong-Yeon Kim) announced ‘Supect(generic name: radotinib),’ the 18th Korean new drug candidate for the treatment of Parkinson’s disease, was approved to be published in ‘Human Molecular Genet...

High expectations on special plans for ‘desk for illegal rebates,’ CSOs

The industry might find new approaches to manage CSOs(contract sales organizations) The reason why the industry has raised interests in CSOs again is because CSO is an official agenda at the ‘Ethical Management Works...

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