The permission from the Ministry of Food and Drug Safety in Korea (MFDS) to allow DTP shipments comes as medical centers in Korea have been partially closed due to the fear of spreading MERS. Thirty-three people have so far died from the outbreak, according to the government, but Tuesday was the third consecutive day that the government did not report any new cases.
“While no commitments have been made as to the duration of the changes, it does appear that the MFDS is open to review available options as the MERS crisis continues to affect more medical centers,” Marken spokeswoman Christine Noble told us. “The MFDS acknowledges the need to offer continued life-saving medicines to participants. Patients who needed the clinical trial drugs could no longer safely access the infected health centers without risk of exposure to MERS.”
The company said pharma companies and CROs running clinical trials can make requests to the MFDS to allow for DTP shipments. Marken’s shipments so far have been sent to homes in Seoul, Gyeonggi, Boryung in Chungchengnamdo, Gochang in Jeollabukdo, and Yeosu in Jeollanamdo. Marken currently provides DTP services to more than 20 countries.
“DTP is still a relatively new service within the industry,” Noble added. “However, as regulatory changes in each country are different, the rate of adoption is slower in some areas depending on geography of the region, demographics of patients within each country, and the perceived need for these types of services.”