Two announcements have to be highlighted for the area of GMP. The Assembly agreed to begin work on two harmonising guidelines Q13 and Q14 to
- Analytical Procedure Development and Revision of Q2(R1) Analytical Validation (Q2(R2)/Q14), and on
- Continuous manufacturing (Q13)
Work will start with developing formal concept papers and work plans.
The Assembly also discussed future strategic areas for harmonisation by endorsing a strategic reflection paper entitled Advancing Biopharmaceutical Quality Standards to Support Continual Improvement and Innovation in Manufacturing Technologies and Approaches.
Also the number of Council members is constantly increasing. There are now 16 ICH Members and 27 observers on board:
• CFDA, China, HSA, Singapore and MFDS, South Korea join the current standing members
• BIO and IGBA join the current industry members
• TFDA (Chinese Taipei) becomes a new regulatory member.
• Moldavia (MMD), Malaysia (NPRA), Armenia and TITCK (Turkey) are new observers