MFDS “Increasing AAP manufacturing well in progress”

by companies that signed agreements with MFDS... govn't receives monthly report

“The stock shortages in some online malls may not be actual lack of stock”

Manufactured amount increased compared in Dec compared to Nov... will increase manufacturing by 60% until April

To the issue that had been raised on how the supply shortage is continuing in the field even after increasing the price of acetaminophen, the Ministry of Food and Drug Safety replied that it has reviewed the monthly production schedule and the increase in production is progressing according to plan.

 

Also, the MFDS added that the acetaminophen stock shortages found in some online malls may not be an actual lack of stock, and that it would be necessary to check with the distributors.

 

In other words, some online malls may be leaving the category as out of stock to prevent the large pharmacies to preoccupy the whole stock in online malls at once and allow small pharmacies the purchasing opportunity.

 

Eun-hee Moon, Director of the Pharmaceutical Policy Division

Eun-hee Moon, Director of the Pharmaceutical Policy Division at MFDS, said so at a briefing with the medical trade journal correspondents on the 13th.

 

Director Moon said, “Even at the increased price, it is said that the companies cannot manufacture more because they are already at their maximum capacity, and some pharmacies are saying there isn’t enough supply.

 

However, when checking with the manufacturers and reviewing their monthly production schedule, no company has yet said they are having difficulty matching the demand.” The Ministry of Health and Welfare raised the ceiling price of 18 products that contain acetaminophen 650mg to at least KRW 70 to a maximum of KRW 90 as of December 1st.

 

The different ceiling prices have been set according to the manufactured amount.

 

After holding drug pricing negotiations with pharmaceutical companies, the National Health Insurance Service and the companies agreed to increase the monthly average manufacture amount by 50% more for 13 months until September of next year.

 

Also, in consideration of the increased demand and exhaustion of market inventory in the winter and in-between seasons, the period from this month to April next year will be set as an intensive management period, and the monthly target manufacture amount set by 60% more during that period.

 

The average monthly supply will rise the previous 45 million tablets per month to 67.6 million per month for the 13 months, and to 72 million tablets per month during the intensive management period.

 

Also, the MFDS issued an ‘Emergency management and import order for medical products,’ ordering companies that supply prescription acetaminophen 650mg to report their manufacture and import plans, expected monthly manufacture and import and manufacture and import results from December 1, 2022, to April 30, 2023.

 

Director Moon said, “The monthly manufacture amount submitted by the pharmaceutical companies has been set by adjusting the manufactured volume of other drugs.

 

It was not vaguely made." For companies that consign productions, the companies agreed on the price increase after making the production plans for all of its products and confirming their production schedule with their factories.

 

Director Moon emphasized, “Hanmi Pharmaceutical and Chong Kun Dang switched their consigned acetaminophen products to self-manufacturing and submitted their specific manufacture schedules before signing the price increase agreement.

 

The companies are working hard to achieve the goal of expanding production by 50% and 60% more from the previous period according to the plans set by the government.” The MFDS believes that the supply shortages raised in the field will not occur as the contracts that were signed mandate companies to refund the drug price if the production volume does not reach the target amount.

 

Director Moon said, “The MFDS’ manufacture and import order was issued to address the concern that not enough acetaminophen will be supplied in the file even after the NHIS signed agreements with companies that link the production and supply amount to the drug price.

 

As the MFDS and NHIS are managing the issue together, I believe the production of acetaminophen will be carried out as planned." Moon added, “Companies that cannot fulfill the manufacture/import orders were directed to consult with the MFDS, but there has been no talk of companies being unable to meet the volume yet.

 

I have reviewed the production volume until early December, and more acetaminophen is being supplied compared to November." However, as the specific production volumes of acetaminophen in November and December need to be compared, the actual difference can only be found at the end of the year.

 

The MFDS is also preparing a plan to prepare for the supply shortage of raw materials for cold medicine that may arise due to China’s recent lifting of COVID-19 restrictions.

 

Director Moon said, “When checking the raw material suppliers, most were from the US, China, and India, and we think we can use Indian suppliers if there is a disruption in the supply of raw materials in China.

 

While receiving plans for increased production of acetaminophen from companies, we are also checking the current status of raw material supply” The exemptions from the mandatory small-package packaging of prescription cold medicine also continue to be in effect.

 

Moon explained, "We had originally decided to apply the small packaging exemption for the period when we monitor the supply and demand, which is conducted once every two weeks."