Regulatory Open Forum

Dear Forum Members,

13-week repeat dose toxicity study waived by FDA. Discuss the approach for waiver in EU and South Korea before start of registrational trial. The timelines are very tight.

For EU, plan is to transition to EU CTR. Should we approach EMA before the transition for waiver or after the transition? 

For South Korea, plan is submit same justification that was submitted to FDA for the waiver. 

Please advise.

Thank you.

Dear Forum Members,

13-week repeat dose toxicity study waived by FDA. Discuss the approach for waiver in EU and South Korea before start of registrational trial. The timelines are very tight.

For EU, plan is to transition to EU CTR. Should we approach EMA before the transition for waiver or after the transition? 

For South Korea, plan is submit same justification that was submitted to FDA for the waiver. 

Please advise.

Thank you.

The appropriate duration of the repeated-dose toxicity studies is usually depends on duration, therapeutic indication, and scope of the proposed clinical trial. So, if your rationale that was presented to the FDA for waiver is based on the ICH guidance M3, then your rationale should also be acceptable to the EU and South Korea!

For example, for clinical trial duration between 2 weeks to 6 months, you need two studies one in rodent and another in nonrodent species whose duration equaling to the proposed clinical study duration. Interestingly in EU for >6 month clinical study duration, 6 months rodent & non rodent should suffice but in the US, 9 month nonrodent study is required in addition to 6 month rodent study.

Reach out privately if you need further help. 

Dear Forum Members,

13-week repeat dose toxicity study waived by FDA. Discuss the approach for waiver in EU and South Korea before start of registrational trial. The timelines are very tight.

For EU, plan is to transition to EU CTR. Should we approach EMA before the transition for waiver or after the transition? 

For South Korea, plan is submit same justification that was submitted to FDA for the waiver. 

Please advise.

Thank you.

The appropriate duration of the repeated-dose toxicity studies is usually depends on duration, therapeutic indication, and scope of the proposed clinical trial. So, if your rationale that was presented to the FDA for waiver is based on the ICH guidance M3, then your rationale should also be acceptable to the EU and South Korea!

For example, for clinical trial duration between 2 weeks to 6 months, you need two studies one in rodent and another in nonrodent species whose duration equaling to the proposed clinical study duration. Interestingly in EU for >6 month clinical study duration, 6 months rodent & non rodent should suffice but in the US, 9 month nonrodent study is required in addition to 6 month rodent study.

Reach out privately if you need further help. 

Dear Forum Members,

13-week repeat dose toxicity study waived by FDA. Discuss the approach for waiver in EU and South Korea before start of registrational trial. The timelines are very tight.

For EU, plan is to transition to EU CTR. Should we approach EMA before the transition for waiver or after the transition? 

For South Korea, plan is submit same justification that was submitted to FDA for the waiver. 

Please advise.

Thank you.

Thank you for the replies. The guidance is really helpful. I will definitely reach out if I have further questions.

The appropriate duration of the repeated-dose toxicity studies is usually depends on duration, therapeutic indication, and scope of the proposed clinical trial. So, if your rationale that was presented to the FDA for waiver is based on the ICH guidance M3, then your rationale should also be acceptable to the EU and South Korea!

For example, for clinical trial duration between 2 weeks to 6 months, you need two studies one in rodent and another in nonrodent species whose duration equaling to the proposed clinical study duration. Interestingly in EU for >6 month clinical study duration, 6 months rodent & non rodent should suffice but in the US, 9 month nonrodent study is required in addition to 6 month rodent study.

Reach out privately if you need further help. 

Dear Forum Members,

13-week repeat dose toxicity study waived by FDA. Discuss the approach for waiver in EU and South Korea before start of registrational trial. The timelines are very tight.

For EU, plan is to transition to EU CTR. Should we approach EMA before the transition for waiver or after the transition? 

For South Korea, plan is submit same justification that was submitted to FDA for the waiver. 

Please advise.

Thank you.

Hi All,

Thank you for the great discussion. 

For EU, if the strategy is only to get waiver from Spain, should we still go through EMA for scientific advice/or directly approach Spanish AEMPS for feedback?

Please share your thoughts for best approach.

Thank you again in advance.

Thank you for the replies. The guidance is really helpful. I will definitely reach out if I have further questions.

The appropriate duration of the repeated-dose toxicity studies is usually depends on duration, therapeutic indication, and scope of the proposed clinical trial. So, if your rationale that was presented to the FDA for waiver is based on the ICH guidance M3, then your rationale should also be acceptable to the EU and South Korea!

For example, for clinical trial duration between 2 weeks to 6 months, you need two studies one in rodent and another in nonrodent species whose duration equaling to the proposed clinical study duration. Interestingly in EU for >6 month clinical study duration, 6 months rodent & non rodent should suffice but in the US, 9 month nonrodent study is required in addition to 6 month rodent study.

Reach out privately if you need further help. 

Dear Forum Members,

13-week repeat dose toxicity study waived by FDA. Discuss the approach for waiver in EU and South Korea before start of registrational trial. The timelines are very tight.

For EU, plan is to transition to EU CTR. Should we approach EMA before the transition for waiver or after the transition? 

For South Korea, plan is submit same justification that was submitted to FDA for the waiver. 

Please advise.

Thank you.