Introduction of Quality Certification Center

The Quality Certification Center is working to improve quality and manage the safety of Korean medicines to quell negative impressions caused by distribution and use of defective medicinal herbs—a problem that has stood as a concerning barrier against further development of the industry.

One: Block import of low quality herbal medicines

The Quality Certification Center having been designated as the official testing and inspection agency by the Korea Food and Drug Administration (KFDA) for pharmaceutical products, low quality medicinal herbs cannot pass customs to enter Korea.

- Pharmaceutical products are broken down into three classifications: medicinal products, non-medicinal products, and herbal medicines. Since 2009, the Quality Certification Center has been inspection agency for the herbal medicines, and from 2017, its jurisdiction has expanded to medical-use medicinal herbs, meaning that it is the sole screening agency in Korea that is capable of handling both the pharmaceutical and herbal medicine industries.

Two: Distribute appropriate herbal medicines and medications domestically

The Center also supports quality inspections of medicinal herbs produced by Good Manufacturing Practices (GMP) manufacturers and facilitates the distribution of appropriate medicinal herbs to be used for treatment.

- The medicinal herb GMP system sets standards for all parts of on-site processing management and manufacturing and quality control that ensures quality medicinal herb products for processing and supply.

Three: Research standards for quality management 

The Center presents reasonable standards for the production of safe and high-quality herbal medicines, and has received a number of research requests to further improve standards. The Center collects samples of herbal medicines that are distributed in Korea and has proposed a revision to the official processing standards that would include monitoring medicine quality while also testing hazardous substances like residual pesticides, heavy metals, or aflatoxins. In addition, the Center uses cutting-edge analysis instrument to improve quality control testing methods.

Four: Provide fortified quality management training

With financial support from the Western Pacific Regional Office (WPRO), the Center had been invited six researchers from Mongolia and Vietnam to Korea for a two-year quality control training fellowship to study quality control strengthening methods. In addition, based on the three-year, in-house training for medicinal herb manufacturing quality control officers in Korea, the Center is now providing a public interest service with customized training programs for any interested party who applies.

Five: Manage safety of drinkable medicines

It is anticipated that health insurance schemes will introduce benefits to cover Korean medicine in the future, and the Center preemptively monitors raw materials and drinkable medicines to ensure quality of manufactured herbal medicines. Through this, a safety management system is being set up to guarantee that quality drinkable medicines are being supplied to the Korean public.

For Korean medicine and Korean herbal prescription testing requests, please visit the National Development Institute of Korean Medicine (NIKOM) website at www.nikom.or.kr to download the application form.