The Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) took place on 17 and 18 November 2021. Dr Gabriela Zenhäusern of Swissmedic was elected Assembly Vice-Chair. The Assembly was followed on 19 and 22 November by the eighth meeting of the Management Committee of the International Pharmaceutical Regulators Programme (IPRP), during which key issues were discussed. The eight IPRP Working Groups presented their achievements over the past months and their future activities. The meeting was held in a virtual setting in view of the COVID-19 pandemic.
Swissmedic supports the ICH’s ongoing development into a global initiative
The virtual Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) took place on 17 and 18 November 2021. The ICH Assembly welcomed the Mexican authority COFEPRIS as a new ICH Member along with three new ICH Observers: EDA (Egypt), Indonesian FDA (Indonesia) and SECMOH (Ukraine). With the new additions, the ICH has a total of 19 Members and 35 Observers.
Lenita Lindström-Gommers (EC, Europe) was re-elected as Assembly Chair for a two-year term of office. Dr Gabriela Zenhäusern of Swissmedic was elected Assembly Vice-Chair. Dr Zenhäusern is Deputy Head of Stakeholder Engagement at Swissmedic and becomes the second Assembly Vice-Chair from Switzerland, the post having been first held by a Swiss in 2018.
Furthermore, Dr Theresa Mullin (FDA, USA) and Dr Nobumasa Nakashima (MHLW/PMDA, Japan) were re-elected as Management Committee Chair and Vice-Chair respectively.
The ICH Assembly endorsed the following Guidelines by consensus (Step 4):
- Electronic Common Technical Document (eCTD) v4.0 Question & Answer Document v1.6 and eCTD v3.2.2 Question & Answer Document v1.32
- ICH E8(R1) Guideline on General Considerations for Clinical Studies
When Guidelines are endorsed by consensus within the ICH organisation, 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 ICH Assembly also endorsed the establishment of informal Working Group ICH M15 “General Considerations for Model-Informed Drug Development (MIDD)”.
The Assembly also noted the ICH 30th Anniversary Publication published on the ICH website in October 2021, providing an overview of ICH’s history and current work.
The next ICH Assembly will take place on 24 and 25 May 2022.
Eighth meeting of the IPRP Management Committee
Representatives of regulatory authorities attended the virtual meeting of the Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) on 19 and 22 November 2021.
During the IPRP MC meeting, the IPRP Working Groups on nanomedicines, cell therapy, gene therapy, identification of medicinal products (IDMP), quality, biosimilars, bioequivalence for generics, and pharmacovigilance reported on their achievements over the past months and their future activities.
The main focus topics at the second IPRP meeting in 2021 were reliance and e-labelling, the same topics discussed at the first meeting. The MC will continue the discussion on technical aspects of reliance and on identifying steps for concrete action within IPRP, taking account of the roles played by other forums such as ICMRA (International Coalition of Medicines Regulatory Authorities). The e-labelling survey launched within IPRP will be extended further. The intention is to summarise the results in an article which is scheduled for publication in 2022.
Furthermore, IPRP Members shared their experience of the challenges they have encountered while implementing ICH Guidelines, particularly ICH Q12 on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. The MC will keep this topic on the agenda of forthcoming meetings with the aim of facilitating the implementation of ICH Guidelines.
The next IPRP meeting will take place on 25-26 May 2022.