Clarifying the conditional approval target

The Advanced Bio Act, new regulation of cell and gene therapy

The MFDS, reflecting enough safety devices afterwards

Chief Ho-sang Jeong (left) & team leader Jeong-won Oh (right), who conducted briefings with the reporters on the 7th

The MFDS strictly enforces the Advanced Bio Act (the Act on the “Safety and Support of Advanced Regenerative Medical and Advanced Biopharmaceuticals”), and said that concerns about safety are only a concern.

 

However, the conditional approvals subject to the enacted legislation will maintain the previous conditions.

 

Ho-sang Jeong, chief of the Cell Gene Therapy Products Division, and Jung-won Oh, leader of the permission team of the MFDS, who is in charge of the screening and licensing parts of the cell and gene therapy products, said in a press briefing on the 7th.

 

On August 28, the MFDS issued an administrative notice by setting up 'Regulations for Permit and Examination of Items for Advanced Biologics' prior to the implementation of the Advanced Bio Act.

 

Accordingly, advanced biopharmaceuticals such as cell therapies and gene therapies that have been applied to the existing the pharmaceutical affairs law will be subject to the new regulations within the framework of the new law.

 

Although the number of licensed items for cell and gene therapies in Korea is small, it is a new kind of treatment, and there are many items developed by listed ventures, which is of interest.

 

In addition, the necessity for strengthening the permit screening is being raised through the case of Invossa, a gene therapy product that has been canceled.

 

Some are also raising concerns about whether drugs subject to expedited review or drugs subject to conditional approval, such as exemption of a phase III, will be screened with neglecting safety.

 

In response, the MFDS explained that safety measures were faithfully reflected in the law to prevent safety problems.

 

For example, a follow-up management system, such as a long-term follow-up survey, was established.

 

""In fact, even before the law was enforced in August, the screening system for cell and gene therapies was prepared similarly to the standards of developed countries," said Ho-sang Jeong.

 

He said, "The Advanced Bio Act supports high-tech biopharmaceuticals while strengthening safety at the same time, and the rapid review regulations that existed at the public notice level have been enacted, so that the drugs subject to rapid review can be approved within a short period of time." In the meantime, "the criteria for rapid review or conditionally approved products have been clarified, so that there are no concerns about safety due to the misuse of conditionally licensed medicines at some point." He added, "The management became tighter while clarifying the measures for under-conditional items." The MFDS is also considering the input of screening personnel tailored to this.

 

The conditional approval was mainly a system to conditionally phase III clinically and approve items in phase II completion.

 

It was possible because there were no existing treatments, significant life-threatening diseases, or endpoints that could predict clinical benefit.

 

However, these conditions were abstract, and there were few cases where conditionally approved drugs were actually used in patients.

 

The MFDS recognized this problem and explained that the Advanced Bio Act clarified the requirements for conditional approval or expedited examination.

 

Accordingly, it is expected that there will be fewer cases of disagreement over the conditional approvals with companies.

 

The MFDS recently filed a lawsuit against Pharmicell for a conditional license for 'Cellgram-LC' and lost it.

 

However, it is the policy that the conditional permits and pre-licensed items will maintain the previous conditions.

 

The Advanced Bio Act states that licensed items must be re-applied within one year after promulgation.

 

Accordingly, 16 items of cell therapy products must be re-applied.

 

Some of these items are licensed under the condition of phase III.

 

"The three items are conditionally approved under the premise of phase III clinical trials, and the items under phase III clinical trials are planned to maintain the existing license conditions until the re-application is made," said Jeong-won Oh.

 

"On the 3rd, the information submitted to companies with re-permitted items was guided.

 

Basically, safety and effectiveness data have similar requirements according to the pharmaceutical affairs law.

 

They have to submit the data in CTD version," he explained.