News About: Pharm. Affairs
Celltrion’s ‘Remsima’ to expand into Middle Eastern market, starting with Saudi Arabia
Celltrion acquired approval to sell Remsima from the Saudi Arabian regulatory authority, the Saudi FDA(Saudi Food and Drug Authority), on the 20th of April, and begun the sales from the 19th of Mar.
On a basis of the...
Shin Poong Pharm acquires approval of its modified drug, Pyramax’Shin Poong Pharm(CEO Jae-man Yoo) announced approval of its incrementally modified drug, a child malaria treatment ‘Pyramax Gran’ having pyronaridine phosphate as a main substan...
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Adoption of ‘Rolling Review’ for innovative drugs, shortening 6 months of approval process
“The key feature of the Special Act is the ‘Rolling Review’ which exclusively review products indicated as innovative drugs. It’s completely different from the current Prompt Approval and Review System.”
The core of ...
177 products imported among 203 new drugs approved in Korea after 2010
It was aggregated there were the total 203 products of new drugs approved after 2010: 177 products imported and 26 products manufactured in Korea.
Via the ‘2015 Pharmaceutical Approval Report,’ the Ministry of Food a...
18 incrementally modified drugs approved last year
Last year, 18 incrementally modified drugs were approved, and antidiabetics had the highest portion in the total with 7 products.
The Ministry of Food and Drug Safety announced the last year’s approvals of 18 increm...
Telemedicine dispensers displaying 60 OTC drugs, burdened by pharmacists
The Ministry of Health and Welfare(MOHW) announced it had previously opposed to both controversial matters of the telemedicine dispenser and ETC drug parcel service. Also, it stressed they are nothing to do with telem...
First defense for Zemiglo on 1st next month
A conflict for the sales right of the LG Life Sciences’ domestic antidiabetic ‘Zemiglo’ will be handled in a courtroom.
According to the industry on the 17th, Sanofi-Aventis Korea, the previous seller of Zemiglo, wi...
D-day for ‘telemedicine dispenser & ETC drug parcel service’
The entire healthcare industry is paying attention to whether the decision to approve telemedicine dispensers and pharmaceutical parcel services, which had been strongly opposed to the pharmacists’ society, will be ma...
High chances for telemedicine dispensers to be pushed forward
The Korean Pharmaceutical Association(KPA) is making urgent moves since agendas about approving telemedicine dispensers for OTC drugs and pharmaceutical parcel services are about to be introduced at the Ministers’ Reg...
Imbruvica & Vimizim registered for insurance benefits under special case system
A series of rare disease products that are applied by the special case system of economic evaluation will be registered for the health insurance benefit.
They are the Janssen’s mantle cell lymphoma treatment Imbruvi...
