News About: Pharm. Affairs


Expert Committee, ‘We accepts importance of creating legal bases for off-label uses’

Importance of creating a revision bill to the Pharmaceutical Affairs Law, which create a base to evaluate safety and efficacy about off-label use of pharmaceutical drugs, was accepted. Young-Hwan Seok, a senior exper...

Keytruda Inj and Opdivo Inj approved promptly for off-label use

The Health Insurance Review & Assessment Service(President Seung-Taek Kim, HIRA) decided to approve off-label uses of Keytruda Inj(generic name: pembrolizumab) and Opdivo Inj(generic name: nivolumab), immune checkpoin...

‘Prohibition of advertisements for OTC drugs consumed as ETC is immoderate’

An opinion was shared that a bill to prohibit advertisements for OTC drugs that are similar to a ETC drug is an immoderate regulation. Young-Hwan Seok, a senior expert member at the Health and Welfare Committee, said...

Medicine- or drug-related names can only be used by drug manufacturers or sellers from December

Every business owner, but pharmaceutical manufactures and sellers, will be imposed a fine for using a name similar to medicine and drug from the coming December. The Ministry of Food and Drug Safety gave a pre-announ...

Registered medicines are now available to acquire separate approval as orphan drug

In order to promote manufacturing of orphan drugs, a system will be improved for already registered medicines to acquire separate product approval as am orphan drug. The Minister of Food and Drug Safety(Minister Youn...

“They need to understand International Nonproprietary Names is an international trend”

The Korean Pharmaceutical Association(President Chan-Hwi Cho, KPA) criticized the Korean Medical Association’s(KMA) argument about the ‘International Nonproprietary Names(INN)’ program was ‘implausible,’ and gave a cr...

“International Nonproprietary Names(INN) is necessary for patient safety”

Greeting the FIP Seoul Congress, the International Pharmaceutical Federation(FIP) stressed that the International Nonproprietary Names(INN) are an international trend and told it was required for the government, pharm...

Endless medicine manufacturing suspension and out of stock status

There have been an endless number of medicines with production suspension or temporarily going out of stock. According to the industry concerned, Dong Wha Pharm’s ‘Flamotol Tab,’ Reyon Pharmaceutical’s ‘Opti-V Eye Dr...

FIP Seoul Congress, event for world pharmacologists and pharmacists, opens

The ‘77th 2017 FIP World Congress of Pharmacy and Pharmaceutical Sciences,’ a grand festival for pharmacologists and pharmacists in the world, has opened in Seoul, South Korea. On the subject of ‘Medicines and beyond...

Inist to jointly develop oral ‘bazedoxifene/cholecalciferol’ combination drug

Inist Bio Pharmaceutical(CEO Kook-Hyun Kim) will conduct an open innovation service of its product based on its know-hows as a CMO(contract manufacturing organization). The company will open a briefing to suggest joi...

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