Utilizing RWD for Re-evaluation of Old Drugs

Limits to maintaining validation permits without clinical data

Need to establish procedures

Discussions were conducted at the Central Pharmacist Review Committee on the criteria for clinical re-evaluation of items licensed on the basis of foreign drug formulas without efficacy evaluation.

 

The drug was Hanall Biopharma's "Blistop (p-Aminomethyl Benzoic Acid)" and was approved on May 16, 2001, and its efficacy expired on April 1.

 

At the time of approval, Blistop was awarded to the eight major foreign drug formularies, allowing item approval without clinical data.

 

However, with the recent revision of the permit regulations, it is impossible to permit drug formalities alone, and efficacy evaluation standard of "old drugs" used in the field for decades without efficacy evaluation has become controversial.

 

According to the minutes of the committee's "Advice on the adequacy of drug item renewal" held by the MFDS on the 29th of last month, it was very difficult to prove its effectiveness through clinical re-evaluation.

 

The MFDS said, "The items licensed based on foreign formularies have already been used in clinical sites for decades, and what to do with efficiency evaluation is a problem in the renewal of Old Drugs." "In consideration of not only clinical re-evaluation but also the use of RWD, we will only recognize the efficacy that can prove its validity through protocol review and approval procedures," he explained.

 

Currently, the company has submitted opinions on clinical re-evaluation, and the MFDS is considering various methods such as clinical trials as well as post-marketing clinical trials.

 

In this regard, a member said, "In the situation where there are differences in permission for each drug used for hemostasis, Blistop is well used so far in clinical sites," adding, "Since there is no significant adverse reaction, it is reasonable to give opportunities according to the company's will." Another member suggested, "It is difficult to objectively judge the validity of all drugs approved in the past.

 

The MFDS needs to ease regulations on Old Drugs and prioritize safety evaluation over efficacy." It is unreasonable to impose restrictions on drugs that have been used for a long time since there is no safety problem, and the effectiveness is evaluated in the market, and drugs that are not effective will be eliminated in clinical practice.

 

However, the MFDS agrees that the need and use in the market can naturally induce eviction, but there is a limit to maintaining permission as it is effective in the absence of clinical data as foreign formularies, the basis for licensed drugs, disappear.

 

At the meeting that day, it was decided to renew the p-Aminomethyl Benzoic Acid item on the premise of validation.