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  • Renewal of Marketing Approval for drugs, will be reinforced
  • by Lee, Tak-Sun | translator Choi HeeYoung | Mar 31, 2020 06:29am
Drugs without sales records can not be renewed
The MFDS promotes Renewal of Marketing Approval of drugs
It was originally possible to renew under circumstances having production or income achievements within 5 years validity.
Renewal System of Marketing Approval for Drugs ongoing since 2018 will be further reinforced.

The system which gives a 5 year validity for each category respectively, renews allowance after reviewing safety and effectiveness. However, it is criticized that the screening does not properly evaluate the safety and effectiveness of pharmaceuticals.

Accordingly, the MFDS decided to strengthen the renewal review by comprehensive review of ingredients and formulations, refrain from renewing unsold items, and compulsory submission of post-market safety data.

According to the industry on the 30th, the MFDS recently released the first comprehensive plan for drug safety management (from 2020 to 2024).

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