Consolidated List of ICH Guidelines and Updates Published in 2022
Period: January 2022 to December 2022
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international organization that develops guidelines to help ensure the quality, safety, and effectiveness of pharmaceutical products. These guidelines are used by pharmaceutical industry professionals to help ensure that they are meeting regulatory requirements and producing high-quality products. Some examples of how ICH guidelines can be helpful for pharmaceutical industry professionals include:
- Providing guidance on how to develop and manufacture pharmaceutical products in a way that meets regulatory requirements
- Outlining the information that should be included in regulatory submissions for new pharmaceutical products
- Providing recommendations for testing and quality control procedures to ensure the safety and effectiveness of pharmaceutical products
- Helping to ensure that pharmaceutical products are consistently produced and meet the necessary quality standards
- Providing guidance on the clinical development of pharmaceutical products, including the design of clinical trials and the evaluation of data generated from these trials
Overall, ICH guidelines can help pharmaceutical industry professionals to produce high-quality, safe, and effective products that meet regulatory requirements and can be trusted by patients and healthcare providers.
Following are the Consolidated List of ICH Guidelines published in the year 2022.
| Guideline/ Update | Date | Details | Source Link |
| The ICH published Training Material on E9(R1) its website | January 28, 2022 | On 28 January 28, 2022 ICH announced the availability of training material on ICH E9(R1) “Addendum on estimands and sensitivity analysis in Clinical trials to the guideline on statistical principles for clinical trials” | Link |
| The draft of ICH Q2(R2) reaches at Step 2 process | March 31, 2022 | Revision of ICH Q2(R2) reached to Step 2 of the process on March 24, 2022. At this stage, it enters at public consultation stage. The guidance included following main topics: Analytical use of spectroscopic or spectrometry data such as Raman, NIR, MS, or NMR, with multivariate statistical analyses. Draft ICH Q2(R2) and ICH Q14 will complement guidelines ICH Q8 to ICH Q13. Q2(R2) – Draft version of Validation of Analytical Procedures and Q14 Analytical Procedure Development draft version endorsed on March, 24 2022 | Link-1 Link-2 |
| The ICH E11A draft Guideline reaches Step 2 of the ICH process | April 5, 2022 | ICH E11A draft Guideline is open for public consultation as per the ICH news. This guideline provide information related to The Paediatric extrapolation approaches that can be used and systematic approach for paediatric extrapolation Study designs and statistical analysis methods that can be used for a paediatric drug development plan. | Link |
| ICH published “The ICH E8(R1) Introductory Training Presentation” | April 28, 2022 | The ICH E8(R1) Guideline is related to General Considerations for Clinical Studies. The guideline is reached Step 4 of the ICH Process on 6 October 2021. This Step 4 Presentation (Introductory Training) is developed by the Experts. | Link |
| The Model-Informed Drug Development (MIDD) Discussion Group, which was established in January 2021, has provided as an output of its discussions, considerations with respect to future MIDD related guidelines in the form of a “roadmap”. | May 3, 2022 | The Model-Informed Drug Development (MIDD) Discussion Group, which was established in January 2021, has provided as an output of its discussions, considerations with respect to future MIDD related guidelines in the form of a “roadmap”. | Link-1 Link-2 |
| 2021 Free Text Comments Report and Consistent Cohort 2019 vs 2021 ICH Implementation Study | May 19, 2022 | The text has been published to analyze anonymised comments from the industry participating in the most latest survey done in 2021. The purpose for this study was to: Provide further context to results from the survey Add value on informing training associates Inform future surveys. | Link-1 Link-2 |
| The ICH conducted a hybrid meeting on May 21 to 25, 2022, in Athens, Greece, for the first time. | June 1, 2022 | The hybrid meeting was done where both in-person and virtual participation were present from 7 Groups, the MedDRA Management Committee, the ICH Management Committee, and the ICH Assembly. Topic discussed and details of the meeting are: Further expansion of ICH Membership and Observership Progress on existing ICH Guidelines and harmonisation activities New areas of ICH harmonisation Training MedDRA Communication For detailed reading refer link below. | Link |
| The ICH Q3D(R2) Introductory Training Presentation is now available on the ICH website | June 23, 2022 | As per the news from ICH, A Step 4 Introductory Training material is developed and it is available on the website. | Link |
| ICH published draft Guideline presentation of ICH M12 | July 15, 2022 | This Step 2 info Presentation has been prepared by the M12 Expert Working Group post publishing draft Guideline on Drug Interaction Studies. | Link |
| Addendum to S1B reaches Step 4 of the ICH Process | August 15, 2022 | This document has been signed off on August 4, 2022. The document is developed based on a Concept Paper of Nov 14, 2012 and a Business Plan. This addendum to ICH S1B is supported by scientific advances. Many retrospective study conducted by the agency confirmed that an integrative Weight of Evidence approach could be applied to adequately assess the human carcinogenic risk for certain pharmaceuticals in lieu of conducting a 2-year rat study without compromise to patient safety. As per the ICH, this is a more integrative and comprehensive approach to assessing human carcinogenic risk of pharmaceuticals. | Link |
| ICH E19 Guideline reaches Step 4 of the ICH Process | October 4, 2022 | On September 27, 2022, the ICH E19 Guideline on A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials reaches Step 4 of the ICH Process. This Guideline is designed to give globally harmonised recommendations on the use of selective safety data collecting – by modifying the manner of safety data collection, it may be able to carry out clinical trials with improved efficiency by simplifying the data gathering process. This might make large-scale effectiveness and safety clinical studies with huge numbers of participants and long-term follow-up easier to undertake. More information is available on the ICH E19 website. | Link |
| The ICH process has moved to Step 2 with the proposed Q5A(R2) guideline | October 11, 2022 | The R2 revision preserves core ideas from the original Guideline while also making new suggestions on recognised and complementary techniques to preventing virus contamination of biotechnology products. The Q5A(R2) EWG created a Step 2 Informational Presentation to summarise the substance of the proposed Guideline. | Link |
| The proposed ICH M11 guideline has reached Step 2 of the ICH process | October 21, 2022 | A comprehensive clinical protocol organisation with standardised content is proposed by this new guideline, along with: a Template outlining the protocol’s format and structure, including its table of contents, common headers, and contents; and a Technical Specification outlining the conformance, cardinality, and other technical characteristics that permit the interoperable electronic exchange of protocol content. | Link |
| ICH published Introductory Training Presentation on E19 on its website | October 25, 2022 | This Guideline is designed to give globally harmonised recommendations on the use of selective safety data collecting – by modifying the manner of safety data collection, it may be able to carry out clinical trials with improved efficiency by simplifying the data gathering process. This might make large-scale effectiveness and safety clinical studies with huge numbers of participants and long-term follow-up easier to undertake. | Link |
| Press Release: ICH Assembly Meeting, Incheon, Republic of Korea, November 2022 | November 22, 2022 | The International Council for Harmonisation (ICH) Assembly convened in person on the 15th and 16th of November 2022, in Incheon, Republic of Korea, in tandem with sessions of 10 Working Groups, and was preceded by meetings of the ICH Management Committee and the MedDRA Management Committee. The meeting was an essential chance to progress the work of the ICH’s thirty-three Working Groups as well as critical initiatives such as training. The ICH Assembly also welcomed DPM, Tunisia as a new ICH Observer, raising the total number of ICH Members and Observers to 20 and 36, respectively. To read more about Progress on current ICH Guidelines and actions towards harmonisation, refer to the following link. | Link |
| ICH M13 draft Guideline reaches Step 2 of the ICH process | December 21, 2022 | The ICH M13A Guideline is part of the anticipated ICH M13 Guideline series (M13A-C) and is intended to provide recommendations on conducting bioequivalence (BE) studies for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension. | Link |
