Approval Standards for Innovative Drug Makers Stay the Same as 2012
Approval Standards for Innovative Drug Makers Stay the Same as 2012
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  • 승인 2013.01.31 14:50
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[SEOUL=Healthkoreanews] Approval standards for innovative pharmaceutical companies turned out to be the same as those of last year. the approval is due within the first half of the year.

According to an official of Ministry of Health and Welfare 30 Jan, the minimum requirement for approval this year will be 5~7%, the same as that of last year. The companies with less than 100 billion won of drug sales should meet the condition that R&D investment ratio be over 7%. For the companies with more than 100 billion won of drug sales, the ratio should be over 5% to qualify for the application.

Since the standards are expected to get higher within a few years, the drug companies aiming to be approved as such will do well to apply within next year. The ministry is planning to escalate the standards to 10~12% in 2015, 15~17% in 2018. 

The ministry will implement the change starting year 2015 through the revision of related notification.

The point of time and approval is expected to be almost the same as last year. Last year, application period was from 4 May to 18 June. 

The number of applicant firms, however, is expected to decrease as compared with last year. Last year, 43 firms were approved, which raised criticism that the number is so high that the meaning of approval was tainted.  
An official from the ministry said, "the total number will be less than 43."

As major domestic drug makers are facing the risk of dropout due to past rebate practice, the trust in the approval of innovative pharmaceutical companies was lost. Market observers, however, agree that the practice of approval itself cannot be abandoned.  

In fact, Ministry of Health and Welfare and National Assembly invite the innovative pharmaceutical companies only to various meetings and discussions, cementing the notion that they only have to communicate with the limited numbers of innovative companies. Approval of Innovation function as the communication channel with government.

Also, since future government policy orientation and support is likely to be focused on innovative drug makers, major trend cannot be reversed, said officials.

An official from pharmaceutical industry said, "Application will be made for our part. Government calls only innovative firms and media coverage is done on a daily basis. The concern that even though the sales shows well, without the approval the companies will fall behind is rampant. That's why the company has a plan to apply next year."

 -대한민국 의학전문지 헬스코리아뉴스-


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