Yoo Moo-young, director general of the Pharmaceutical Safety 

Bureau at the Ministry of Food and Drug Safety. 

(photo: courtesy of Ministry of Food and Drug Safety)

By Oh Chung-sook

The Ministry of Food and Drug Safety is to put into practice a relief scheme to compensate victims suffering from drug side-effects later this year. The following are excerpts of an interview between NewsWorld and Yoo Moo-young, director general of the Pharmaceutical Safety Bureau at the Ministry of Food and Drug Safety, in which he spoke of his bureau’s major policy plans and pending tasks.

Question:  Will you tell us about your bureau’s 2014 major policy projects and the pending tasks?

Answer: The biggest policy shift in pharmaceutical safety control is the full-fledged implementation of relief measures for adverse drug reactions. So far, victims suffering from drug side-effects have to verify the cause-effect relationship of the adverse drug reactions through a complex lawsuit system in order to receive compensation. Starting later this year, drug users can be compensated based on the Korea Institute of Drug Safety & Risk Management (KIDS)’s examination of the causes of the adverse reactions even though they use drugs as prescribed in accordance with a revision of the Act on Pharmaceutical Affairs, approved during a parliamentary session this past February.

Pharmaceutical firms will shoulder compensation costs for the damages related to adverse drug reactions. The relief measure scheme will be expanded to cover death compensation, lump-sum disability benefits, funeral costs, and medical treatment fees on a gradual basis. 

We plan to revamp and to prevent the recurrence of accidents that could undermine the reliability of the quality of drugs, like the one related to an overdose of a major substance in a fever reducer for children, which occurred last year, and the forging of distribution periods.  The MFDS has already put on public notice a proposed revision of regulations on the safety of medicines in order to upgrade Korea’s Good Manufa-cturing Practices (GMP) to the levels of advanced countries in late February. We’re also seeking to revise the Act on Pharmaceutical Affairs, which would impose fake and substandard drug producers with penalties equivalent to 5 percent of the value of sales and imports. 

The ministry will come up with diverse support policies to change the structure of the Korean pharmaceutical industry into one with a focus on the development of new drugs and their export. We’re devoting ourselves to achieving a target of joining the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S) within this year. Our ministry plans to ramp up support for Korean pharmaceutical companies’ inroads into foreign markets by seeking to promote collaboration projects with international organizations, including the World Health Organization and the International Coalit-ion of Medicines Regulatory Authorities (ICMRA) and to sign information exchange agreements with regulatory authorities of major countries. We’ll strive to make Korean standards on medicine review and approval conform with international standards, including those of the Interna-tional Conference on Harmon-ization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), while continuing to conduct regulatory reform lest procedural approval and review regulations, unrelated to safety, stay in the way of pharmaceutical firms’ activities. 

Q: Duvie, an anti-diabetes drug, was approved as Korea’s 20th new drug to be produced and sold on the domestic market. Will you elaborate on the current status of the development of new drugs?

A: Interministry support to develop new drugs and pharmaceutical companies’ R&D activities have paid off. Sunpla, an anti-stomach cancer drug, produced by SK Chemicals, obtained approval as the nation’s first new drug in 1999. Since then, 20 new drugs, including four cancer and three erectile dysfunction treatment drugs, have been approved. Among the new drugs is FACTIVE tablet, an antibiotic, produced by LG Life Science, which was also approved by the U.S. Food Drug Administration. 

Kanarb®, the nation’s new anti-hypertension drug produced by Boryung Pharm Co., posted some 23.5 billion won in sales in 2012. Boryung Pharm has so far agreed on deals to export a combined $200 million worth of Kanarb®  to Brazil, other Central and South American countries, and China.

Clinical trials, approved in 2013, showed that a total of 22 clinical tests are underway for treating stomach, endocrine system, and central nervous system diseases. They include Phase III trials for treating chronic hepatitis B and diabetes. 

Our ministry plans to aggressively provide support to pharmaceutical companies’ development of new drugs by upgrading new drug approval and review regulations to the levels of advanced countries and implementing a prior review system.  

Q: Concerning an increased concentr-ation of an active ingredient for Tyenol syrup products for children, produced by Janssen Korea’s plant last April, what steps are in place to beef up surveillance of GMP processes for medicine? 

A: The cause of the accident related to the fever reducer for children is attributable to the fact that many advanced systems have been introduced in a short period of time, but loopholes surrounding a failure in firming up some were exposed. 

The MFDS plans to firm up the domestic GMP system by taking a lesson from the accident so that Korean pharmaceutical companies will have the confidence of the people and make inroads into foreign markets by making the system conform with international practices. To this end, the ministry will conduct an inspection into medicine GMP once every three years in accordance with the PIC/S guidelines. Drug producers found to violate regulations on pharmaceutical production and quality management internationally will be sternly dealt with through punitive penalties that may incur irretrievable economic losses. 

Q: Do you have any plan to strengthen public relations toward the prevention of drug abuse?

A: Public concern over drug abuse has been mounting as a major social issue in the wake of the recent revelation of entertainers’ abusing propofol. A stream of unfounded information abetting drug abuse has been flooding SNS and the internet. Unless this information is blocked, worry is increasing about the possibility that it could endanger public health in an irreparable manner. 

The ministry endeavors to aggressively inform people of the dangers of drug abuse while continuously pushing for exploration of collaboration projects with the private sector such as the Korean Association against Drug Abuse and other consumer bodies to build a society without drug abuse. It will conduct publicity projects to inform the general public drug abuse’s danger to health and to lead to behavior changes. 

Q: Will you introduce steps to reinforce management of pharmaceutical imports?

A: Korea’s safety management of pharmaceutical imports is integral to ensuring safety management of all drugs across the nation since Korea depends on foreign countries for a 21 percent share of finished pharmaceutical products and a 77 percent interest of medicinal substances.

Management of pharmaceutical imports has been so far done on paper, screening for import approval. Safety problems surrounding substances of heparin, a blood thinner, and dextromethorphan, a cough suppressant drug, took place around the world, touching off international cooperation to strengthen safety management of overseas drug production sites.

The ministry plans to establish a regime to manage foreign drug production sites by requiring registration of finished drugs and substance makers whose import has been approved or applied. 

The MFDS plans to expand on-site inspections into foreign drug production sites based on inspection records and risk assessments such as the occurrence of safety problems. We plan to impose a ban on the import of drugs suspected of safety problems to ensure safety management of imports. 

We also plan to ramp up the sharing of information on imported drugs on a constant basis by securing ways to collaborate in quality management, such as the signing of MOUs with foreign regulatory authorities, while strengthening checks into imported drug depositories to ensure quality management of imported drugs in the process of storage and distribution. 

Q:  Will you explain the steps to ramp up quality management of imported phar-maceutical raw materials and a scheme to make Korea a hub of pharm-aceutical substances?

A:  The production and export of pharmaceutical raw materials are surging. Korea saw production and export of finished pharmaceutical products drop 1.1 percent and rise 7.9 percent, respectively, between 2010 and 2012. On the other hand, production and export of pharmaceutical raw materials soared 10 percent and 12.6 percent, respectively, during the same period. 

The performance was owed to Korean pharmaceutical companies’ strenuous efforts to strength quality management of medicinal raw materials and secure their overseas recognition and standing. Our ministry has been operating the Drug Master File (DMF) system to secure quality management of pharmaceutical raw materials. Under the system, designed to improve quality management of Korean-made drugs by shutting the use of substandard pharmaceutical substances, 394 substances have been registered so far and drug makers are required to use the substances registered. Our ministry strives to establish a virtuous cycle of enhancing the quality of substance through the DMF and bring about a rise in production and export by gaining the confidence in products from Korean and abroad.