Meetings of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and of the International Pharmaceutical Regulators Programme (IPRP)

08.07.2021

The virtual Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) took place in the week beginning 31 May 2021.

The ICH Assembly welcomed the Saudi Food and Drug Authority (SFDA) as a new ICH Member as well as two new ICH Observers: the Analytical Expertise Center (AEC) of Azerbaijan, and the UK Medicines and Healthcare products Regulatory Agency (MHRA). These new additions have expanded the ICH to a total of 18 Members and 33 Observers.

The Assembly endorsed the following Guidelines by consensus (Step 4):

• Q3C(R8) Guideline on Impurities: Guideline for Residual Solvents, revised to include the Permitted Daily Exposure (PDE) levels for 2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether and Tertiary Butyl Alcohol.
• M8 eCTD v4.0 Question and Answer (Q&A) Document v.1.5, Specification for Submission Format for eCTD v.1.3, and eCTD v4.0 Implementation Package v.1.4.

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).

Furthermore, the Assembly supported the revision of two quality Guidelines and the drafting of a new Guideline on pharmacoepidemiological studies:

• Revision of ICH Q1 Guidelines on Stability Testing and related ICH Q5C Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products.
• Revision of ICH Q6A and Q6B on Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances and Biotechnogical/Biological Products.    
  
• New ICH Guideline on General Principles on Planning and Designing Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of a Medicine.

The Assembly was also informed of an upcoming publication to mark the ICH’s 30th anniversary. This publication will be made available on the ICH website. 

The next virtual meeting of the ICH Assembly will be held on 17 and 18 November 2021.

Further information on the Management Committee elections, the survey on the implementation of Guidelines, training activities and MedDRA can be found in the press release issued by the ICH:

In the week commencing 7 June, representatives of the regulatory authorities attended the virtual meeting of the International Pharmaceutical Regulators Programme (IPRP) to discuss the latest developments in the IPRP working groups.

The focal topics at the first IPRP meeting of 2021 included reliance, a topic already discussed at the previous meeting, and e-labelling, i.e. the provision of product information via electronic channels. The IPRP conducted a survey on e-labelling among Members and Observers, the results of which will be used as basis for discussions on regulatory requirements and e-labelling concepts. The results of the survey will be summarised in an article due to be published during 2022.

In addition, IPRP Members and Observers shared their experience of implementing ICH Guidelines and the challenges involved. Given the importance of implementing ICH Guidelines, the Management Committee will retain the topic as an agenda item for future meetings.

The next IPRP meeting will take place on 22/23 November 2021 and will once again be held virtually. Further information can be found in the Public Statement issued by the IPRP.