Minor Quality Changes During Clinical Trials Do Not Require Prior Approval from MFDS

From now on, minor quality changes to investigational medicinal products during clinical trials will not require prior approval from the regulatory authorities.

On the 31st, the Ministry of Food and Drug Safety announced that it has revised and distributed the "Quality Guideline for Investigational Medicinal Products" to apply minor quality changes that do not affect the safety of trial subjects or the quality of investigational medicinal products as self-managed items. A ministry official explained, "This revision was prepared to clearly define the scope of self-management for companies and support the prompt conduct of clinical trials."

According to the revised guideline, although testing standards have been strengthened, cases such as extending the shelf life of investigational medicinal products according to an already approved stability testing plan when not related to safety, applying revised standards from the Korean Pharmacopoeia or other official compendia after clinical trial approval, and changing the manufacturing scale of chemical drugs by up to tenfold do not require approval for changes from the Ministry.

Major overseas countries such as the United States and Europe also allow companies to self-manage minor risk changes in the quality of investigational medicinal products during clinical trials. A ministry official stated, "We expect this guideline revision to help ensure the safety of clinical trial subjects while facilitating the swift progress of clinical trials."

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