Meeting of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Excellent Progress made on ICH harmonisation activities in Prague, Czech Republic


The Assembly of the International Council for Harmonisation (ICH) met in-person on 31 October and 1 November 2023, in Prague, Czech Republic, in parallel to meetings of 16 Working Groups, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.

The ICH continues to expand and was delighted to welcome PPBHK, Hong Kong, China, as a new ICH Observer, bringing ICH to a total of 21 Members and 37 Observers.


The Management Committee, MedDRA Management Committee, and Assembly Chair and Vice-Chair elections were held during the meeting, which saw the following appointments:

  • Ms Lenita Lindström (EC, Europe) and Dr Gabriela Zenhaeusern (Swissmedic, Switzerland) were re-elected as Assembly Chair and Vice-Chair;
  • Dr Theresa Mullin (FDA, United States) and Mr Naoyuki Yasuda (MHLW/PMDA, Japan) were re-elected as Management Committee Chair and Vice Chair;
  • Dr Barbee Whitaker (FDA, United States) and Dr Craig Simon (Health Canada, Canada) were elected as MedDRA Management Committee Chair and Vice-Chair.

Adoption of ICH guidelines and important revisions

  • ICH Q5A(R2) Revised Guideline on “Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin” reached Step 4 and was adopted by the ICH Assembly Regulatory Members. The revision provides additional recommendations on established and complementary approaches to control the potential viral contamination of biotechnology products.
  • ICH Q2(R2) Revised Guideline on “Validation of Analytical Procedures” and the new Q14 Guideline on “Analytical Procedure Development”, which were developed in parallel by the Q2(R2)/Q14 EWG, reached Step 4 and were adopted by the ICH Assembly Regulatory Members. This new Q14 Guideline is intended to improve regulatory communication between industry and regulators and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures.

When guidelines are endorsed by consensus within the ICH organisation (Step 4), they are regarded as harmonised and therefore as “documents that reflect the current state of science and technology” (see Swissmedic Journal 05/2006, p. 504).

The next ICH Assembly meeting is scheduled on 4 and 5 June 2024 in Fukuoka, Japan.

Further information can be found in the ICH press release: