EMA “供上市许可持有人使用的亚硝胺信息”问答20200327.pdfVIP

27th March 2020 EMA/CHMP/428592/2019 Rev. 3 Questions and answers on “Information on nitrosamines for marketing authorisation holders” Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. Table of contents Introduction 3 1. Are all products to be reviewed? 3 2. What factors should be considered in prioritizing the risk evaluation? 3 3. How should the risk evaluation be implemented? 4 4. How should tests be conducted by MAHs and manufacturers? (UPDATED) 4 5. When should MAHs report to competent authorities? (UPDATED) 5 6. What limits will apply for nitrosamines detected in any products? (UPDATED, See also QA 16) 6 7. What are the deadlines for the evaluations? 6 8. Which changes would be required to Marketing Authorisations? 6 9. What are the responsibilities of MAHs for APIs with CEPs or ASMFs? 7 10. What about regulatory requirements in other regions? 7 11. How will regulators ensure ongoing dialogue with industry? 7 12. What are the currently identified root causes for presence of nitrosamines? 8 13. What is the approach for new and ongoing marketing authorisation applications (MAA)? (UPDATED) 8 14. Are biological products containing excipients potentially at risk of contamination with Nitrosamines in the scope of the review? 9 15. What to do if after completing step 1 and /or step 2 new information on new potential root causes is identified? 9 16. What limits will apply for nitrosamines in medicinal products based on lifetime and less than lifetime use? 10 Questions and answers on “Information on nitrosamines for marketing authorisation holders” EMA/CHMP/428592/2019