MFDS is speeding up the COVID-19 vaccine screening

2021 Administrative and Institutional Pharmaceutical Industry Settlement - the MFDS

Permission within 40 days of the COVID-19 vaccine review

Starting with Binex, random manufacturing companies are caught one after another

Detection of impurities in anti-smoking and high blood pressure treatments

In 2021, the MFDS focused on speeding up the screening of COVID-19 vaccines aimed at 70% of the nation's vaccinations.

 

As a result, the screening period for COVID-19 vaccines and treatments has been significantly advanced, contributing to the achievement of the goal.

 

Unexpected inspections have begun on manufacturers to cope with illegal manufacturing incidents triggered by media reports.

 

In addition, as impurity issues from overseas erupted one after another this year, drugs such as Sartan and Varenicline were recovered by inducing corporate self-inspection.

 

Choline alfoscerate formulations, which have controversy over efficacy, were prepared in June with a clinical re-evaluation plan.

 

◆COVID-19 vaccine and treatment screening=As the government formalized the vaccination of the COVID-19 vaccine from the first quarter, the MFDS focused on advancing the approval period by mobilizing all personnel for product screening.

 

As a result, vaccines were approved 40 days after receipt, and the National lot release was also completed 20 days after approval.

 

Starting with AstraZeneca in February, Pfizer in March, Janssen in April, and Moderna vaccines in May were approved one after another.

 

Most of them were achieved 40 days after the start of the permit review, and the National Lot Release was immediately carried out, and the vaccination began quickly.

 

The EUA system has been enacted as a law to provide an institutional environment so that it can be urgently introduced even before formal approval.

 

As a result, in October, Moderna vaccines commissioned by Samsung Biologics were able to receive EUA and supply them to the market.

 

◆Illegal manufacturing= Overseas COVID-19 vaccine confirmed the capabilities of the domestic pharmaceutical industry by selecting a domestic manufacturer as a production source, but it was also revealed that it was manufactured arbitrarily unlike permission.

 

The MFDS, which immediately went into crackdown after hearing media reports, found that BINEX and Vivozon had illegally manufactured them in March.

 

Additives were arbitrarily changed without permission, and some document manipulation appeared in the process.

 

As a result, manufacturing and sales of related items were temporarily suspended and recovered.

 

BINEX was found to have arbitrarily manufactured 32 items, including consignment and consignment manufacturing.

 

Since then, the MFDS has set up a counter for internal complaints with the GMP special planning and inspection team and started unannounced inspections of all manufacturers.

 

As a result, violations such as Hanall Biopharma, Chung Kun Dang, Dongin-dang, Hansol, Samsung, Jeil, and Medicakorea were found.

 

As the MFDS proceeded with administrative measures against the caught companies, some pharmaceutical companies were treated as criminal charges.

 

Illegal random manufacturing cases are currently under investigation by the prosecution, which is expected to have repercussions depending on the situation.

 

◆Choline alfoscerate, outline of clinical reevaluation= The clinical trial plan for this was finally approved in June when the MFDS issued a clinical re-evaluation order last year due to controversy over the effectiveness of the "Choline alfoscerate" drug raised by the National Assembly and civic groups.

 

Each company decided to participate in consideration of cost and probability of success.

 

As a result, a total of 57 companies expressed their intention to participate in the group led by Daewoong Bio and Chong Kun Dang, which have the highest sales in the market.

 

Daewoong Bio and Chong Kun Dang conduct clinical re-evaluation of the efficacy of Choline alfoscerate's treatment of Alzheimer's dementia for 4 years and 6 months and mild cognitive impairment for 3 years and 9 months.

 

All other indications were deleted as the revaluation effect was limited to Alzheimer's dementia and mild cognitive impairment.

 

With the confirmation of the revaluation plan, each company has since started negotiations with the NHIS to recover benefits in the event of a clinical revaluation failure.