The Ministry of SMEs and Startups Invested 400.2 Billion Won…

 Korea: The Ministry of SMEs and Startups invested 400.2 billion won this year to support the construction of a total of more than 6,000 smart factories, including 3,300 by the government and 2,700 by private companies such as large, small and medium-sized enterprises (SMEs). In order for biopharmaceutical companies to build smart factories, it is essential to introduce QbD. The Ministry of Food and Drug Safety is also operating a QbD consulting support project to foster smart factory leading pharmaceutical companies.

It was in 2014 that the Ministry of Food and Drug Safety showed its will to introduce QbD. Then, in March, some pharmaceutical companies were found to have manufactured a number of products arbitrarily different from the drug approval, so the consulting support was expanded this year. QbD can reduce the risk of random manufacturing by designing drug processes within normal product tolerances.

The Ministry of Food and Drug Safety announced on the 5th that it had selected five pharmaceutical companies to support consulting this year. Last year there were two. The Ministry of Food and Drug Safety provides customized consulting for about three months by identifying the development status and product characteristics of the companies concerned. The problem is ‘lack of manpower and expertise’

The introduction of QbD can strengthen industrial competitiveness by reducing drug defect rate, △improving consumer safety, and △increasing production efficiency. In fact, Daewoong Pharmaceutical, which received consulting support from the Ministry of Food and Drug Safety last year, upgraded its production technology for injection of ‘Fexuprazan’, a new drug for gastroesophageal reflux disease, through the introduction of QbD. As a result of Daewoong Pharmaceutical’s introduction of QbD, the freeze-drying process time of fexuprazan injection was cut in half. Production costs were reduced by 35% and production capacity increased by 1.5 times.

Korea Pharma also received consulting support from the Ministry of Food and Drug Safety last year. Through consulting, Pharma Korea has more than doubled the tablet tableting speed of drugs currently under development. Of course, it is possible to reduce production time and reduce costs. Pharma Korea plans to apply for approval from the Ministry of Food and Drug Safety as a QbD-based drug within this year for drugs currently under development. In 2017, Dong-A ST conducted QbD research while participating in the Ministry of Food and Drug Safety’s modeling project to develop a QbD application model. Currently, we are preparing to introduce QbD to some items.

In fact, so far, the domestic permit review process has not had much to do with the introduction of QbD. Unlike in Korea, it is important to introduce QbD abroad. In the US, Europe, Japan, etc., QbD status affects the evaluation in the permit review process.

Then, on April 30, the Ministry of Food and Drug Safety suddenly revised and enforced the ‘Regulations for Approval, Reporting, and Review of Drugs’, which included the introduction of QbD into the drug approval review and evaluation system. The amendment allows flexible change management within the scope of accreditation if QbD contents are reflected and described during drug manufacturing. It also serves as a basis for omitting some test items when shipping finished products. The importance of introducing QbD has grown even more.

The biopharmaceutical industry was taken aback by the move by the Ministry of Food and Drug Safety. The introduction of QbD in the biopharmaceutical industry has many advantages. It not only improves quality, but also saves time and money in the long run. The industry is also aware of the advantages of QbD adoption. However, there are many opinions that the conditions for introducing QbD are not yet sufficient.

In fact, the biopharmaceutical industry has not yet accelerated the introduction of QbD. So far, there are no drugs that have applied QbD in Korea. Most of them are in the research stage or are applied only for export. Even if QbD is introduced, there is no professional manpower to operate it, and the cost burden such as the establishment of a smart factory is high. Accordingly, there is an opinion that the government needs incentives such as policy support for the rapid introduction of QbD in the biopharmaceutical industry.

An official from the pharmaceutical industry said, “In order to promote QbD adoption by biopharmaceutical companies, the shortage of professional manpower must be addressed first.