ICH опубликовала окончательный концептуальный документ нового руководства ICH Q12
- 25 февраля 2015
- CMC, ICH Q12,
Recently, ICH published a Final Concept Paper for a new ICH Q12 Guideline entitled “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”. There is currently a lack of a harmonised approach on technical and regulatory considerations for product lifecycle management. While the concepts in ICH Q8, Q9, Q10 and Q11 provide opportunities for a