Module 3 - Strategic case studies in practice

3.3. QWP consultations.............................................................................................. 64 3.3.1. Summary of QWP responses to first CHMP LoQ.................................................... 64 3.3.2. Summary of QWP responses to second CHMP LoQ ............................................... 65 3.4. SWP consultations .............................................................................................. 66 3.4.1. Summary of SWP responses to first CHMP LoQ.................................................... 66 3.4.2. Summary of SWP response to second CHMP LoQ................................................. 70 3.5. PRAC consultation .............................................................................................. 71 4. Conclusions ........................................................................................ 73 4.1. Root causes for presence of N-nitrosamines........................................................... 73 4.2. Analytical methods for N-nitrosamines .................................................................. 74 4.3. Setting Limits for N-nitrosamines in human medicinal products ................................ 75 4.3.1. Presence of more than one N -nitrosamine .......................................................... 76 4.3.2. N-nitrosamines with insufficient toxicological data ............................................... 76 4.3.3. Less-than-lifetime (LTL) approach ..................................................................... 76 4.4. Considerations on epidemiological studies ............................................................. 77 5. Recommendations .............................................................................. 77 6. References.......................................................................................... 82

EMA/369136/2020

Page 3/90