The Ministry of Food and Drug Safety is preparing to implement the “Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals,” which takes effect on Aug. 27 next year. By the end of this year, the ministry aims to complete the draft of the enforcement decree and rules.
As the law deals with R&D and safety management of advanced biopharmaceutical products such as cell therapies and gene therapies, pharmaceutical and biotech companies are paying keen attention to the new law’s difference from the existing one.
Kim Eun-ju, deputy director of the ministry’s Biopharmaceutical Policy Division, met with reporters explaining about preparation for the upcoming law, on Tuesday.
Question: When do you plan to finish devising up the subordinate legislation of the Advanced Regeneration Bio Act?
Answer: We will make a draft by the end of this year. On Aug. 28, we set up an internal task force consisting of a system team, a permit review team, a long-term tracking team, a post-management team, and a general team. We will make the draft and reflect industry opinions, and continue to share content with the industry and collect their views. On Sept. 20, we had the first meeting with “Dynamic Bio,” which we set up to better communicate with Korea Biomedicine Industry Association, to exchange opinions. At the meeting, we discussed the procedure and the method of implementation of the subordinate law.
Q: The task force was created to make a draft of the subordinate law of the Advanced Regeneration Bio Act. Do you plan to make another task force so that industry officials can participate in during the subordinate legislation?
A: Of course, we do. If we’re completed with the draft, the task force will have industry officials’ participation. As we integrated our efforts for advanced regenerative medicine and advanced biopharmaceuticals under the Advanced Regeneration Bio Act, we made a consultation body with related agencies, including the Ministry of Health and Welfare, to communicate with the industry regularly.
Q: How does the GMP standard for cell therapies differ from the existing GMPs? The pharmaceutical industry is concerned about a change in installation standards, which increases investment costs.
A: A cell therapy uses live cells, so companies should take extra caution in the manufacturing process and quality control. Cell therapy has a short shelf life, and the quantity of customized production is usually small. Companies should do a long-term follow-up on such treatment. Therefore, it is not possible to put cell therapies in the category of the existing Pharmaceutical Affairs Act. So, lawmakers made the Advanced Regeneration Bio Act as a special law. GMP set by the Advanced Regeneration Bio Act will be very different from the existing GMP.
As the special law overrides other laws, the Advanced Regeneration Bio Act will override the Pharmaceutical Affairs Act. That explains why we’re trying to be more careful. We hope that the pharmaceutical industry could express their opinions to us before we carry out the subordinate legislation.
Q: One of the important points of the Advanced Regeneration Bio Act is the “full-cycle safety management system” for biopharmaceuticals. Can you prevent an incident like Invossa recall?
A: As we said earlier, when the bill passed the National Assembly, we put an item, “full-cycle safety management system” in the subordinate law. First, we newly categorized a business that specializes in cell management, such as collecting raw material cells. The bill has a section for the cell management plan, stating requirements in cell management ranging from cell collection to cell management.
Second, we will enhance safety management based on GMP of advanced biopharmaceutical manufacturing sites.
Third, we will monitor all the production and management, from cell collecting and culturing to making finished goods. Initially, biopharmaceutical companies will submit the same safety and efficacy report, just as drugmakers do. Then, they will have to provide genetic data.
Fourth, as we mandated companies to submit long-term post-marketing surveillance, we can say we have prepared a measure to ensure safety.
Q: How do you plan to categorize advanced biopharmaceutical products?
A: Advanced biopharmaceuticals, based on cells and genes, are newly developed products, so there are some ambiguities about whether they are classified as pharmaceuticals, medical devices, general medicines, biopharmaceuticals, or advanced biopharmaceuticals. How the classification is applied will affect which regulations apply. So, we introduced a system to categorize items at the initial stage.
Many people worry about the “fast track system,” only thinking of conditional approval, but in fact, there are three types in this.
First, we will introduce a customized review system to meet the developer’s schedule. It takes 10 to 15 years to develop a drug, and the company submits this data to the food and drug safety ministry all at once. The amount of submitted materials is usually about 30-40 boxes of A4-sized paper. Of course, it takes a long time to review the drug. To solve this problem, we developed a system so that a company can submit data in advance according to the stages of drug development such as nonclinical safety pharmacology and toxicology testing, phase-1 and phase-2 study.
Second, if a company is eligible for the fast-track review of advanced biopharmaceuticals, we will prioritize the review of the advanced biopharmaceutical product rather than reviewing drugs by application numbers.
Third, the new law will have conditional approval. Some might say it is the same as the existing law. But the current law does not provide practical benefits to advanced biopharmaceutical developers because it does not state any detailed procedure or method for advanced biopharmaceutical development to win conditional approval. As the new legislation came, companies will find it easy to utilize conditional approval in the subordinate law.
Q: Businesses often regard law as “a regulation.” Do you think the Advanced Regeneration Bio Act will support the regenerative medicine and advanced biopharmaceuticals?
A: The law comprises both regulation and support. The name of the new law added “Safety and Support.” It means that safety management should come first and that the law will provide a system to support the development and commercialization of biopharmaceutical products.
That shows why the official abbreviation is “Advanced Regeneration Bio Act.” As long as a company secures the safety of a candidate drug, we will help the industry speed up, making the agent a product and secure treatment opportunities for patients with rare or incurable diseases.