Korea FDA Moving To Strengthen Pharmacovigilance - APEC Harmonization Center Asia Regulatory Conference
This article was originally published in The Pink Sheet Daily
A national pharmacovigilance system will integrate an electronic management system in cooperation with the Korea Drug Safety Management Center, local pharmacovigilance centers, public health institutions and government hospitals.
You may also be interested in...
Voices From Emerging Markets Expected At Next ICH Steering Committee - APEC Harmonization Center Regulatory Conference
SEOUL - When ICH was created in 1990, Japan, U.S. and EU were the only participants, but more and more regulatory agencies are adopting variations of ICH guidelines for their own countries. In June, ICH's technical working groups will for the first time be expanded to include regional harmonization initiatives (RHIs), which regulators are calling a "dramatic change" towards global harmonization
SEOUL - Nearly a year after the South Korean Health Ministry announced new policies aimed at eradicating bribery and promoting more transparent drug pricing, effects of a new drug-pricing system remain unclear, industry watchers say
FDA wants a bigger stick for product-specific Risk Evaluation and Mitigation Strategy negotiations, if for no other reason than to end the talks and make the final decision.