Minister Chung Seung of the Ministry of Food and Drug Safety (MFDS) said the ministry is making preparations to create new guidelines so medical systems can easily be added to smartphones.
“As to a debate surrounding Samsung Electronics’ heart rate monitor that heated up during last year, in reality, there is a sort of a need for creating institutional foundation,” Minister Chung said.
He hinted at a possibility that his ministry would allow manufacturing companies to market gadgets to use in leisure and sports without registering them as separate medical devices.
“It is realistic to make institutional changes so that companies can give it a try anew by making the most of ICT technology if there are no public safety problems,” he said.
MFDS Minister Chung has been credited with successfully managing MFDS, whose manpower, budget and authority has been expanded since April 2013 when MFDS was elevated to a ministry level. He has also been praised for leading MFDS, one of the nation’s representative regulatory authorities, into one designed to promote the development of industries.
As an example of collaboration between the government and the private sector, MFDS gave the green light to SK Chemical’s cell culture vaccine plant in Andong last December. There were no regulatory guidelines to the construction of the nation’s first cell culture vaccine plant, and MFDS officials and SK Chemical, in charge of the matter, met weekly to discuss all related issues from the stage of design of clinical tests to obtain permission at the earliest possible date.
In its report to President Park Geun-hye in the early 2015, the ministry announced a package of steps to support biomedicines. The Korean government has decided to get one up on advanced countries in their support for pharmaceutical companies wanting to obtain approval in such fields as biosimilars and stem cell based products. Korea became the world’s first nation to approve a system for stem cell based biosimilar, Remsima.
Korea’s gaining the chairmanship of the working group on biosimilars — under the umbrella of the International Pharmaceutical Regulators Forum (IPRF) in 2014 — was possible due to advanced countries’ concern for Korea’s technology prowess in biomedicines, said Minister Chung, adding that Korea needs to take a more aggressive attitude in the field.
Food safety is one of the business areas on which MFDS has attached a top priority since its elevation to a ministry level. The ministry has ramped up manpower investigating substandard and fraudulent food items, while getting tough with violators by giving them more than one year in prison and imposing penalties amounting to 10 times as much as the values sold.
MFDS plans to strenghten its crackdown on online direct purchases from abroad, which are on the rise. Minister Chung said Korean purcahse agents will be required to report imports while the ministry will strengthen monitoring and random checks on foreign delivery companies.
Meanwhile, in his New Year’s message, MFDS Minister Chung said his ministry will make the year 2015 a year of furthering beefing up safety management. He set a goal of establishing basic principles and yielding outcomes.
Circumstances surrounding safety of foods and drugs are changing fast, so with expanding trade among countries, food and drug imports are on the rise, particularly online.
_18.jpg)
