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Regulator to mandate long-term follow-up on advanced biopharmaceuticals
  • By Kim Yun-mi
  • Published 2020.01.15 13:05
  • Updated 2020.01.15 13:05
  • comments 0

“A fast-track review and mandating a long-term follow-up study will be the key issues regarding the Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals, which will take effect in August. The Ministry of Food and Drug Safety prepared for the long-term follow-up measure amid the Invossa-K license revocation last year. To support the advanced regenerative medicine law, the ministry will establish a sub-entity Regulation Science Center that supports and regulates high-tech biologics and provides consultations.”

Kang Seok-yeon, director-general of the Biopharmaceuticals and Herbal Medicine Bureau at the Ministry of Food and Drug Safety, speaks during a meeting with reporters on Tuesday.

Kang Seok-yeon, director-general of the Biopharmaceuticals and Herbal Medicine Bureau at the Ministry of Food and Drug Safety, made these and other remarks during a meeting with reporters on Tuesday. He explained how the ministry would manage the safety of patients treated with the now-suspended osteoarthritis gene therapy Invossa and how the ministry was preparing to operate the law to support advanced regenerative medicine and biopharmaceuticals.

“Last year was a period of great difficulty for medical manufacturers, starting with the shortage of artificial blood vessels. Artificial breast implants had to be recalled, and we detected a potential carcinogen (NDMA) in some drugs,” Kang said.

As for the ongoing legal fight against Kolon Life Science over the cancellation of the Invossa license, he expected that the suit would continue for two or three years.

The ministry regards the patients’ safety as most important and decided to conduct a follow-up study on Invossa-treated patients for 15 years, Kang said.

“Some criticize the food and drug safety ministry for a slow action in enhancing the patients’ safety, but we’re in the final stage to get hospitals’ cooperation to participate in the long-term follow-up,” he said.

Kang emphasized that as the long-term study will take 15 years, not just one or two years, the government would “solidify basics from the ground up.”

Building a patient safety management system will be the central pillar of the long-term follow-up system under the advanced regenerative medicine support law, the director-general noted.

If a pharmaceutical company applies for drug approval by submitting a long-term follow-up plan, the ministry will take the plan into account and grant the nod or conditional approval, according to Kang. Not all advanced biopharmaceuticals will be subject to the new rule. The ministry will designate items considered to require a long-term investigation by reviewing clinical data, systems, and documents, Kang added.

Next month, the food and drug ministry is to put notice the new enforcement decree and regulations related to the advanced regenerative medicine support law.

The operation of the advanced regenerative medicine support law will center on Regulation Science Center, which will manage long-term follow-up investigations, support advanced biopharmaceuticals, and provide consultations, Kang said.

The food and drug ministry should establish or designate the Regulation Science Center as a sub-institution.

“Establishing a new organization will not be easy, so it is more likely that the ministry will designate an entity. We’re discussing how many workers it should have and how much budget it needs,” Kang added.


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