The Ministry of Food and Drug Safety (MFDS) announced its administrative plans for this year Tuesday, vowing to eliminate “chemophobia,” people’s concerns about the drug safety.
The ministry’s plan, unveiled during its report to Prime Minister Lee Nak-yeon, comes after the agency faced various issues with food, drug and household goods safety issues last year.
During the meeting, the ministry expressed its intention to actively support the safe release of high-quality pharmaceuticals, while maintaining the fundamental safety. The agency also plans to bolster safety management of cosmetics and quasi-drugs.
Specifically, the ministry plans to manage the use of fluorescent materials and preservatives in sanitary products, including toilet paper and disposable diapers strictly. It also will designate hair-loss concealer and hair-removing wax as cosmetics to strengthen the management of raw materials such as preservatives and colorants.
The department will also implement a Women's Health Safety Project after detecting harmful substances in sanitary pads, which caused public outrage. The MFDS, the Ministry of Environment and the Korea Centers for Disease Control and Prevention have been conducting a joint epidemiological study on all sanitary pads since December.
Management of pregnant and lactating products will also receive additional guidelines under the ministry’s new plans. Such directions include applying HACCP certification on vitamin supplements and other nutritional supplements for pregnant women, as well as adding safety guidelines for medicines and medical devices used during pregnancy and lactation.
Regarding pharmaceuticals, the ministry plans to strengthen safety management for pharmaceuticals and medical devices after finding foreign substances such as insects in certain IV fluids and syringes last year.
To this end, the ministry aims to inspect manufacturing facilities to ensure their compliance with Good Manufacturing Practices (GMP), while expanding the use of phthalates, currently limited to sap sets, to human contact devices such as transfusion sets by June.
The ministry will also integrate and operate a cyber-surveillance function to eliminate illegal online sales and false and hype ads while introducing the National Petition Test System, which conducts inspections upon public concerns or request.
While fortifying drug regulations, the ministry intends to expand the provision of essential national drugs such as tuberculosis drugs. It plans to increase the number of essential national medicines from 211 last year to 300 this year, and to 500 by 2020.
The ministry will also provide technical support for vaccine self-sufficiency. It expects that 20 vaccines will be self-supported by 2020, boosting the vaccine supply rate to 80 percent.
In relations to the Fourth Industrial Revolution, the ministry plans to activate a consultation team of experts dedicated to examining ICT and advanced bio-medical equipment promptly. It will also institute an approval system for the rapid development of new-technology medical devices such as artificial intelligence (AI), 3D printing and other advanced biopharmaceuticals, such as cell therapy and gene therapy by December.
Other goals mentioned during the meeting included plans to expand the relief system for drug side effects to non-insured drugs, support domestic vaccines and biosimilar companies win WHO’s quality certification and establish an integrated medical information system linking information from every drugstore.
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