[Reporter's view] Are you ready to use

advanced renewable medical data ?

The 'Act on the Safety and Support of Advanced Recycles and Advanced Biomedicines' will be in effect for three years in August.

 

The Advanced Recycled Bio Act prepares a system for securing the safety of advanced renewable medicine, provides a plan for technological innovation, and practical use, and stipulates the necessary matters to secure the quality, safety, and effectiveness of advanced biopharmaceuticals, and to support commercialization.The Advanced Recycled Bio Act has been implemented, and 36 cell treatment facilities and 32 human cell management institutions have been approved in Korea.

 

Cell therapy is made in Korea to export technology to foreign countries, or the CMO/CDMO business of biopharmaceuticals is actively underway.

 

As if proof of this, 'BioKorea 2023', which was held from May 10th to 12th, was presented by a high-tech renewable medical center for the first time, and various sessions were held on the theme of revitalizing clinical research on advanced renewable medicine and exploring the direction of the development of the high-tech biopharmaceutical industry.

 

A speaker who attended the site at the time said that the regenerative medicine session was formed for the first time in Bio Korea, and that it was time to seek industrial development as well as domestic advanced regeneration bio research.

 

However, it has only been three years since the High-Tech Recycled Bio Act was implemented, so it seems that there is still a long way to go.

 

The Ministry of Health and Welfare has expressed its will to improve regulations to revitalize clinical research on cutting-edge bioregenerative medicine treatment technology.

 

It is said that the clinical research application target will be expanded and the clinical research results can be linked with approval, but the position of the researchers conducting the actual research was a little different.

 

It is said that it is urgent to prepare a legal basis for the activation of clinical research data based on the Temple of Heaven's Regenerative Bio Act.

 

In fact, there have been various attempts to utilize the health care big data platform, but the linkage rate between each institution is low as it still hits the wall of personal information.

 

Even if you use data from multiple platforms, you have no choice but to hit the limits of using it with your gender, name, and date of birth alone.

 

In the end, this phenomenon seems to be bound to occur in the use of advanced regeneration bio clinical research data.

 

There is a provision in the Advanced Recycled Bio Act that 'if you need a head of a safety management agency, you can request the provision of data such as unique identification information', but it is not enough to expand it to pharmaceutical companies and clinical research practitioners.

 

In accordance with the Advanced Recycle Bio Act, the basic plan for advanced renewable medicine and advanced biopharmaceuticals is established every 5 years.

 

Three years are coming, and the time is coming soon to come up with a second basic plan.

 

When you try to take advantage of the accumulated endless health care big data, you have to remember the many hurdles.

 

Data from high-tech regeneration and biopharmaceuticals that have just crossed 2/3 of the first basic plan is being collected one by one.

 

In order to actively conduct clinical research with this data, it is necessary to come up with various strategies that can utilize individual unique identification information.