Korean Pharma Regulatory Updates

Korea’s Ministry of Health and Welfare (MOHW) is in the process of implementing 19 key deregulation projects. Of these 19, 10 have already been completed and 9 are underway. The measures include regulatory improvements such as improving the evaluation process for new medical technologies.

Starting in September 2014, drug companies are now able to apply for product reimbursement from the Health Insurance Review and Assessment Service (HIRA) prior to receiving product approval from Korea’s Ministry of Food and Drug Safety (MFDS). Previously, companies had to wait for MFDS approval before applying for reimbursement. HIRA has also implemented some process improvements to more quickly review reimbursement applications. If a company proceeds with both evaluations simultaneously, it should be able to get its drug product on the Korean market 1-2 months faster.

Furthermore, the MOHW is continuing with its efforts to reform Korea’s Pharmaceutical Affairs Act. A draft revision was released in March 2014, and included reforms to patent listing, generic substitution, first-generic exclusivity, drug wholesalers, sale of over the counter (OTC) drugs, fines and other administrative measures. It is expected that the final draft of the Pharmaceutical Affairs Act will be implemented on March 15, 2015 and will be accompanied by detailed supporting regulations and laws.