The South Korean economy is ranked in the top 15 globally, and nominal GDP per capita has surpassed that of European countries like Portugal and Greece. With a population of 50 million, the Korean pharmaceutical market was valued at $15 billion in 2013. This is 75% the size of the drug market in India — which has a population of 1.2 billion. Korea’s medical device market is the third largest in Asia and is expanding at more than 11% annually.
The Korean MFDS revealed plans to increase medical device safety and quality management in a late January 2014 proposed revision to the Medical Device Act. One important amendment would further ensure Korean GMP compliance for imported Class II devices. If the revision becomes law, overseas manufacturing facilities of Class II devices could be inspected, based on certain criteria. Inspections would be conducted by third parties. Device companies that do not have these inspections or are not KGMP compliant would be penalized.
A second key proposed revision is an additional device importer and/or manufacturer business license requirement — hiring a full time, independent quality manager. Medical device firms already in business would have 2.5 years to comply with this regulation. Starting in late July of this year, firms applying for a business license would need to comply with this regulation to be licensed. Non-compliant companies could be fined.
Similarly, the MFDS published revisions to drug safety information management on February 20th. The amendments increase the range of safety information collected, enhance safety inspection reporting, further specify follow-up actions, and require immediate overseas serious adverse event reporting for imported drugs. On February 28th, the Korean National Assembly also amended the Narcotics Control Act. The revisions include the requirement that import and/or export of psychotropic drugs or narcotics must receive advance approval from the MFDS.
On March 10th, the MFDS announced that a 2013 pilot program for patented drug National Health Insurance (NHI) price evaluation would be extended through the end of 2014 and go into full effect next year. The extended program initially applies to new drugs for cancer, cardiovascular disease, cerebrovascular disorder and rare/incurable diseases. The program will allow companies to simultaneously apply for MFDS drug approval and drug price evaluation at the same time, instead of sequentially. This should save drug companies 30-70 days in getting products onto the Korean market.