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Korea to set up new review process for advanced medical devices
  • By Lee Hye-seon
  • Published 2019.01.28 17:35
  • Updated 2019.01.28 17:56
  • comments 0

The Ministry of Food and Drug Safety said it would enhance drug safety management and make a new review process for advanced healthcare goods.

The ministry announced its yearly administrative plan at a news conference in Osong, North Chungcheong Province, Monday.

The ministry’s annual plan emphasized managing the safety of pharmaceutical products and medical device and supplying necessary items as soon as possible. For international coordination, the ministry will not only revise its rules but reinforce cooperation with regulatory institutions overseas, it said.

“We established our 2019 tasks in a mindset that we will contribute to making Korea well and safe in the food and pharmaceutical sector,” Food and Drug Safety Minister Ryu Young-jin told reporters. “We will do our best to secure drug safety, communicate warmly with the vulnerable, and boldly innovate for innovative growth of the pharmaceutical and medical device industry.”

Seoul to tighten control on raw drug materials, harmful substances

Food and Drug Safety Minister Ryu Young-jin announces his ministry’s administrative plans at a news conference in Osong, North Chungcheong Province, on Monday.

The food and drug safety ministry said it would mandate manufacturers of raw drug materials to submit information about the safety of the material and any hazardous substances such as a foreign matter during drug approval and registration from March.

The measure aims to prevent dangerous drugs from selling in the market after the nation suffered a massive recall of carcinogen-containing hypertension drug Valsartan last year.

From December, the government will obligate drug importers to pre-register overseas manufacturers and expand field inspections on companies with high risks. To do so, the ministry will set up a special inspection team to check domestic drug manufacturing books and importers’ quality control on imported drugs for two months from February to March.

The ministry also plans to revise the Korean Pharmacopoeia in September to meet international standards. Pharmacopoeia is a book compiling drugs’ nature, status, quality, storage method, and other necessary criteria. Drugmakers and managers must follow the Pharmacopoeia’s instructions.

The ministry said it would insert new contents following international standards and reflect Quality by Design (QbD) on Good Manufacturing Practice (GMP).

In February, the government will amend the generic drug approval system and mandate companies to submit data for review in line with international standards.

When renewing drug license, the government will take into account history of insurance claims so that it can kick unused drugs out of the market, the ministry said.

Also, the government plans to sign a GMP mutual trust agreement with Switzerland and to list domestic raw drug materials on the EU whitelist, a list of drugs acceptable.

To improve cooperation with advanced regulatory agencies, which was poor during the valsartan recall, the ministry said it would sign a confidentiality agreement with the U.S. Food and Drug Administration and the European Medicines Agency to share information quickly.

Enhancing patient safety, expanding compensation for side effects

The ministry will expand state compensation for adverse drug reactions to non-reimbursed medical costs, and establish the standard compensation procedure for clinical trials in June.

By June, it will conduct an investigation on harmful substances such as herbal remedy benzo[a]pyrene. By September, it will draw up a plan on how to control toxic substances from the packaging of liquid medicines such as injections.

The ministry will strictly monitor narcotic drugs’ distribution and handlers through analyzing big data under the integrated drug management system.

From March, the ministry will provide each physician with prescriptions of narcotic medicines. From September, it will develop a system to allow patients to check their own history of narcotic drug use.

Strengthening support for patients with rare diseases

The ministry will also accelerate projects to help patients with rare and intractable diseases.
The ministry will allow import of hemp-based medicines through Korea Orphan and Essential Drug Center from March. It will also introduce a system in which the government provides the first cost for urgently needed medical devices such as artificial blood vessels for children in June.

In May, the ministry will allow not only local but overseas experimental drugs to be used for treatment and grant approval immediately after the application. In the past, it took seven days.

It will also operate a technology support team to help companies commercialize dementia drugs and diagnostic devices. It will also introduce a quick review system for orphan drugs and treatments for intractable diseases.

Preparing review system for advanced medical goods

In September, the ministry plans to set up a standard for assessment of advanced biopharmaceutical products and quality control, and a multi-phased evaluation for innovative medical devices.

It also will crack down on false reviews on social networking sites and come up with a guideline for consumers to report such cases in March.

In August, the ministry will strengthen verification for the safety and efficacy of implantable medical devices. Regardless of equivalence to conventional devices, they will have to prove safety and efficacy through clinical trials, the government said.


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