ICH touts adoption of continuous manufacturing, safety reporting guidelines

Regulatory NewsRegulatory News | 22 November 2022 |  By 

The International Council for Harmonisation (ICH) announced that “excellent progress” has been made over the past year in advancing guidelines in the areas of pharmaceutical quality, safety and efficacy, including the adoption of the widely awaited guideline on continuous manufacturing (CM).
These achievements were announced on 22 November following its meeting held in Inchon, South Korea. The meeting was held in parallel with meetings of ICH’s ten working groups and was preceded by an ICH Management Committee meeting.
ICH said that “significant milestones” were reached and highlighted the adoption of the Q13 guideline on continuous manufacturing. The Step 4 guideline has not yet been released on the ICH website and the adoption followed the release of the Step 2 draft document in July 2021. (RELATED: ICH releases widely anticipated guidance on continuous manufacturing, Regulatory Focus 27 July 2021)
The US Food and Drug Administration (FDA) has been encouraging the adoption of continuous manufacturing over the past decade to help domestic companies operate with lower costs and fewer quality defects in smaller facilities. Yet only a small number of approved continuous manufacturing applications have been approved in the US.
Data from the FDA’s Emerging Technology Team (ETP), which was created to promote the adoption of advanced manufacturing, including continuous manufacturing, show that more applications are under discussion. Forty-six applications for CM have been accepted into the FDA’s ETP program since the program’s inception in 2014. (RELATED: FDA official offers insights on Emerging Technology Program, Regulatory Focus 16 November 2022)
Other milestones that were reached at the meeting include the adoption of its E19 guideline on the use of selective safety data collection for late-stage trials. The guidance, “A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials,” reached Step 4 status in September 2022. (RELATED: ICH advances guidelines on selective reporting of safety data, viral safety, Regulatory Focus 11 October 2022)
Another milestone was the sign-off of its ICH S1B(R1) guideline which outlines a “weight of evidence” approach to assess the human carcinogenic risk for certain pharmaceuticals instead of defaulting to two-year rat studies. (RELATED: ICH signs off on carcinogenicity testing addendum, Regulatory Focus 22 August 2022)
In other areas, ICH announced that a harmonized template for clinical trials protocols under  M11 was released for Step 2 public consultation in September (RELATED: ICH releases M11 guideline proposing harmonized template for trials protocols, Regulatory Focus, 25 October 2022)
Lastly, ICH announced that a harmonized guidance Q5A(R2) setting harmonized requirements for viral safety testing of biotechnology products reached Step 2 in September 2022. (RELATED: ICH advances guidelines on selective reporting of safety data, viral safety, Regulatory Focus, 11 October 2022)
ICH announces new training modules, new member
ICH also reported the creation of a new training library to incorporate its growing portfolio of training materials. The library will be on the website and include training modules for ICH E2, E6(R3), E8(R1), E17, M4, Q1, Q3, Q5 and the Q8-Q12 series of guidances.
The group also announced that Tunisia’s Direction de la Pharmacie et du Médicament (DPM) joined as a new observer, bringing the number of ICH members to 20 and 36 observers.
In other developments, ICH said the Medical Dictionary for Regulatory Activities (MedDRA) has been updated to include Greek and Polish translations and is now available in 18 languages, with plans for an Arabic translation. ICH reports that over 8,200 users in 134 countries now subscribe to MedDRA.
The next ICH Assembly meeting will be held 12-13 June 2023 in Vancouver, Canada.
ICH announcement


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