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What are development strategies suggested by MFDS for Korean pharmas?

Even since the Patent Linkage System was adopted, about 2,000 patent trials were filed and the court have also started to have different opinions on patent requirements. Thus, Korean pharmaceutical companies were also...

MFDS, “Melatonin cannot be used for health functional food”

In response to a request to change the status of melatonin from medicine to food(health functional food) for insomnia, the Ministry of Food and Drug Safety(MFDS) said ‘no.’ Under the current Pharmaceutical Affairs La...

Kyung Name Pharm’s ‘Lemona’ climbed up the Great Wall of China

Kyung Nam Pharm announced on the 1st that the company’s Lemona and Lemona C Tab acquired the final approval of registration from the China Food and Drug Administration getting over the THAAD issue. The CFDA’s food an...

“Clinical trials must be conducted in order based on ‘social values’”

An opinion was suggested that studies must be performed with regional priority after considering social contexts before conducting them. “A thing to remember when conducting a clinical trial ” Vice President Kathy Ro...

Doctors changed for receiving illegal rebates

Doctors who received rebates from medical representatives working for pharmaceutical company with the purpose of selecting and prescribing the company’s medicines were imposed a fine. On the 2nd, Judge Joong-Min Lee ...

Pharma industry’s continuous unfair requests to provide trade information to distribution companies

The Korea Pharmaceutical Distribution Association decided to interrupt pharmaceutical companies’ unfair requests to provide trade information, and they are still criticized to provide them. According to the industry ...

‘Custom vs. Compensation,’ issue over Novartis’ rebate trial

The Novartis’ rebate trial has been repeated without any solution to a question if symposiums and publication are just an industrial custom or part of compensation. In the meantime, a newly-added witness has caused c...

Gilead Sciences’ chronic hepatitis B treatment Vemlidy with health insurance benefits

Vemlidy(generic name: Tenofovir Alafenamide Fumarate), a Gilead Sciences Korea’s(CEO Seung-Woo Lee) chronic hepatitis B treatment, will receive the national health insurance benefits from the 1st of November. Vemlidy...

Ibrance decided for the health insurance benefit while Olita Tab to be decided later after Phase III clinical trial

The patient sharing amount for Pfizer Pharmaceuticals Korea’s Ibrance Cap(palbociclib) will be reduced from KRW 5 million to KRW 150 thousand with approval of the national health insurance service(NHIS). Hanmi Pharm’...

Samsung Biologics & Merck’s strategic agreement of manufacturing biologics

A pharmaceutical and chemical company Merck announced on the 2nd the company signed a memorandum of understanding(MOU) to agree on strategically manufacture biologics and develop their manufacturing process with Samsu...

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