“Enforcement ordinance for Advanced Regenerative Bio Law will be prepared in February”
“We need to move beyond the bio-similar to the original developing phase”, said Kang Soek-Yeon, director of Biopharmaceuticals department.
As the Advanced Regenerative Bio Law that was passed through parliament last year is planned to be implemented this August, Ministry of Food and Drug safety is stepping up efforts to enact enforcement ordinances and enforcement regulations.
Director of Biopharmaceuticals department from Ministry of Food and Drug Safety, Kang Seok-Yeon has revealed in the meeting on 14th with the reporters who have an access to FDA, that enforcement ordinance of the Advanced Regeneration Bio Act will be prepared by February and will be announced for legislation.
Director Kang has said that the most important issues of Advanced Regeneration Medical and Advanced Regeneration Biopharmaceutical Act on safety and support will be a fast screening and long-term follow up and said the enforcement ordinance and regulation is at the final stage to enact.
The essential part of Advanced Bio Act is a construction of a safety system, mandatory long term follow up process and fast screening test for better opportunity for the patient regarding the usage of advanced biopharmaceuticals on cell collection to its usage.
Director Kang also said, “We have laid much of the foundation for long-term follow up policy while we were handling long term follow up investigation during Inbosa crisis.” “Based on the investigation structure during the Inbosa crisis we will facilitate the long term follow up process of the Advanced Bio Law.”
He continued, “Especially on enactment regulations, Advanced Bio Law has made much of the progress” “Enactment is propelled together with Ministry of Health and Welfare. After discussing within this month, enforcement ordinance will enact within during Februrary.”
He said Korean Biopharmaceutical area has a global competitiveness and the competitiveness of Biosimilar comes from fight against the efficiency.
There is a limit with only the biosimilars and we must move forward to Biobetter and original biopharmaceuticals.
Director Kang said “The major Bio companies like Celltrion and Samsung biologics should go beyond the biosimilar development and to developing bio better and biopharmaceuticals in order to become global enterprise.”
Accroding to Kang, if Advanced Bio Law is enforced then development of treatments for cancer and rare diseases will decrease to 4 years from its usual 12 years.
Until now, although many bio companies who have the technology, they needed to invest a lot of time and budget to prepare the clinical information which acted as a barrier to enter.
However, Advanced Regeneration Bio Law includes regulation regarding clinical research that enables opportunity for those with technology to treat patients legally although it is limited for research purposes.
The purpose of Advanced Regeneration Bio Law is to provide opportunity for treatment once the mandatory safety is secured.
This Advanced Regeneration Bio Act regulation has raised importance of regulatory science research centers.
Regulatory science research center manages, consult and support long-term follow up and development of advanced biopharmaceuticals.
Regulatory science research center is an affiliated organization of Ministry of Food and Drug safety and the Ministry can establish and designate.
Although it is not easy to found a new organization, Kang plans to designate the external organization as a center to manage.
Kang has said, “Regulatory Science Research center needs organization members and budgets so we are currently focusing on these areas. We need management plan for tailored screening, priority screening and partial permits for fast screening policy as well.”