MFDS food safety policy in the second half of 2014

◈ Expansion of mandatory application of HACCP (Food Safety Management Certification Standard) (December)

– 8 items including children’s preference foods and rice cakes and foods manufactured by manufacturers with annual sales over 10 billion won

◈ Food traceability system gradual implementation (December)

–  Mandatory to infant and children food and health functional foods

◈ Formal subscription to Pharmaceutical Inspection Co-operation Scheme (PIC/S) (July)

– Expansion of the scope of application of pharmaceutical manufacturing and quality control standards

◈ Medicines adverse effects damage relief system implemented (December)

– Damage compensation for medicines without complicated litigation

◈ Integrated management of medical devices for in vitro diagnostics (November)

– The items managed as in vitro diagnostics are integrated into medical devices.

□ The Ministry of Food and Drug Safety (Commissioner: Seung Jeong) announced that it will introduce major policies for food and pharmaceutical that is changed from the second half of this year to strengthen the safety of people’s health and improve procedural regulations.

□ The major policies in the food area include ▲ expansion of the use of HACCP (Food Safety Management Certification), ▲ gradual introduction of food traceability, ▲ mandatory nutrient labeling such as limited edition hamburger and pizza and ▲ strengthening the slaughter inspection inspectors of livestock.

○ It is mandatory to apply HACCP in stages starting from December for 8 items including children’s preference foods and rice cakes and foods manufactured by manufacturers with annual sales over 10 billion won and the term ‘hazardous factor key management standard’ is changed to the ‘food safety management certification standard’ for easy understanding of consumers.

※ Items subject to obligation (8 items): confectionery, candy, bread, rice cake, chocolate, fish sausage, beverage, instant food, noodle, instant fried noodle and special purpose food

– In addition, HACCP is obligated to be managed from July for the dairy and milk processing industry which produces milk, formula milk and ice cream.

※ Dairy business: Collection, filtration, cooling or storing raw milk

○ It is mandatory to apply the ‘food traceability system’ from December for the infant and children food and health functional foods for consumers to see the food information from production to processing and distribution consumption at a glance.

○ Limited edition products such as hamburger and pizza sold for less than 90 days a year due to specific business or planning marketing products are obligated to display nutrition labeling such as calorie from December.

○ In order to provide safer livestock products by securing reliability and fairness of slaughter, the slaughter inspection of all livestock such as chicken and ducks will be carried out directly by the inspectors who are public officers.

□ Major policies in the field of pharmaceutical include ▲ Pharmaceutical Inspection Co-operation Scheme (PIC/S), ▲ pharmaceutical manufacturing and quality control standards and ▲ improvement of quasi-pharmaceutical mask item classification system.

○ Since July, Korea has become a formal subscriber to PIC/S, and the level of manufacturing and quality control of domestic pharmaceuticals is recognized globally.

–  The applicable subject of GMP (Pharmaceutical Manufacture and Quality Management) is expanded to raw materials, clinical trials, and radiopharmaceuticals in order to reinforce the quality management.

※ The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is the only international consortium leading the international harmonization of the GMP and GMP inspection (Founded in 1995, headquarter: Geneva, Switzerland)

○ Patients suffering from the side effects of medicines caused by eating medicines normally had to sue against pharmaceutical companies for compensation, However, after December onwards, the ‘medicines adverse effects damage relief system’ will be introduced to compensate without complex litigation procedure.

– Lump sum compensation for death from 2015 onwards, lump sum compensation for disability from 2016 onwards and all kinds of damage compensation from 2017 onwards will be paid.

○ From September onwards, among quasi-medicine masks, the mask for prevention of yellow dust and the mask for prevention of epidemics are integrated into “health mask”. And masks without particle blocking function are excluded from quasi-medicine and managed as industrial products.

□ Major policies in the field of medical devices include: ▲ integrated management of some in-vitro diagnostic medicines such as pregnancy diagnosis kits as medical devices, ▲ regular reporting system and standard codes for medical devices subject to traceability and ▲ introduction of quality management director for medical devices.

○ Items managed under ‘in vitro diagnosis medicines’ such as pregnancy diagnosis kit and cholesterol measurement test papers are integrated to medical devices from November.

○ Standard code is prepared to attach or enter distribution information of traceability medical devices such as an implantable cardiac pacemaker on the container, cover or package and the manufacturer, importer, seller, leaser or repairer must prepare record and data on traceability subject medical device monthly.

※ Medical equipment subject to follow-up: 28 kinds of medical equipment including implantable cardiac pacemaker, implantable cardiac shock machine, blood vessel stent, and artificial respirator are designated as medical devices that can cause fatal damage to human body in the event of a defect.

○ The quality manager is mandatory for manufacturing and importing companies from July in order to secure the responsibility and efficiency of medical device quality and post-marketing safety management.

□ MFDS announced that it will do its best for the people’s happiness and the safety of the people through safe and excellent food, pharmaceutical and healthy diet through the newly implemented system.