The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) met virtually at the end of May. This replaced the conference scheduled to be held in Vancouver (Canada), which had to be cancelled due to the current corona situation. Swissmedic has been a Standing Regulatory Member of the ICH’s Management Committee and a Member of the ICH Assembly since 2015. The ICH Assembly currently comprises 17 Members and 32 Observers.
ICH Working Groups continue their activities online
ICH is committed to the harmonisation of guidelines on the quality and safety of medicines for human use, and thereby helps protect public health in the interest of patients.
The ICH Assembly appointed the Turkish medicines regulatory authority TITCK as a new Regulatory Member and the Ministry of Public Health Lebanon as a Regulatory Observer.
Since the meeting in Singapore in November 2019, three guidelines have reached Step 4 of the ICH process and can therefore be implemented by the regulatory authorities.
- February 2020: ICH S5(R3) Guideline on Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals
- April 2020: ICH S11 New Guideline on Nonclinical Safety Testing in Support of Development of Pediatric Medicine
- May 2020: Q&A v1.3 on the ICH M8 electronic Common Technical Document (eCTD) v4.0
The ICH Assembly approved the formation of the following Working Groups on the drafting and revision of ICH Guidelines:
- Revision of M4Q(R1) Common Technical Document (CTD)
- Structured Product Quality Submissions Work
Discussion Groups were also established to address the following issues:
- General Considerations for Model-Informed Drug Development to support Drug Registration
- ICH E4: Dose Response Information to Support Drug Registration
MedDRA (Medical Dictionary for Regulatory Activities)
The Assembly was informed that MedDRA has been updated in view of the COVID-19 pandemic, resulting in MedDRA 23.0 with approx.70 new COVID-19 terms to facilitate the recording of medical and scientific information connected with COVID-19.
MedDRA is used by over 6,200 organisations in more than 125 countries and is currently available in 14 languages.
The next ICH Meeting will take place in Athens, Greece, from 15-18 November 2020. This year the ICH is celebrating its 30th anniversary. To mark the occasion, a special conference will take place immediately before the November 2020 ICH meeting in