Quality guidelines: lifecycle management

The guidelines on post approval change management protocol and pharmaceutical product lifecycle management help medicine developers prepare marketing authorisation applications for human medicines.

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

Questions and answers

• Questions and answers on the use of Product Lifecycle Management (PLCM) document
• Questions and answers on post approval change management protocols
• ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management