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May 4, 2021

A New Collaboration between SNOMED International and ICH Promotes Seamless Data Exchange in Support of Public Health
On 29 April 2021 the ICH announced a new collaboration between SNOMED International and ICH.

SNOMED International and ICH are announcing the release of important new maps between global medical terminologies SNOMED CT and MedDRA. This collaborative effort is the first deliverable of a new agreement entered into between SNOMED International and ICH.

This joint effort has produced two independent maps (MedDRA to SNOMED CT and SNOMED CT to MedDRA) which have been derived from frequently used and key pharmacovigilance MedDRA terms identified from the EMA and the UK’s MHRA. In addition, a set of COVID-19 related terms are also included in the first production release of the maps to capture important aspects of the pandemic.

The maps are intended to facilitate the exchange of data between regulatory databases (which use MedDRA) and healthcare databases/electronic health records (which use SNOMED CT). In one use case, key pharmacovigilance concepts coded in SNOMED CT in an electronic health record (EHR) could be converted to MedDRA for the purpose of adverse event reporting to regulatory authorities or for the purpose of epidemiological research. In the opposite direction, these same key terms coded in MedDRA representing adverse events, warnings, and other regulatory information could be converted into SNOMED CT so that the information is available in the patient’s record to aid in clinical decision-making.

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Public Web Conference Organised by the ICH E6(R3) EWG
On 26 April 2021 the ICH announced a free public web conference held by the ICH E6(R3) GCP EWG on 18-19 May 2021.

The ICH E6(R3) Good Clinical Practice (GCP) Expert Working Group (EWG) is holding a free public web conference to provide an update on the progress of revising this important and impactful guideline.

The EWG is holding two similar meetings on Tuesday, May 18, 2021 (8-11 a.m. EDT) and Wednesday, May 19, 2021 (6-9 pm JST) to reach a broad global audience across time zones.

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Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases
On 26 April 2021 the FDA published draft guidance for sponsor-investigators.

The purpose of this guidance is to describe the nonclinical information that FDA recommends supporting an investigational new drug application (IND) for an antisense oligonucleotide being developed to treat a severely debilitating or life-threatening (SDLT) disease caused by a unique genetic variant where only a small number of individuals are prospectively identified (usually one or two). The investigational antisense oligonucleotide should be from a well-characterized chemical class for which there is substantial nonclinical information and clinical experience that is publicly available or to which the sponsor-investigator has a right of reference.

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The ICH Q3C(R8) Guideline Reaches Step 4 of the ICH Process
On 23 April 2021 the ICH announced the status of the maintenance process for the ICHQ3C(R8) guideline.

The ICH 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, reached Step 4 of the ICH Process in April 2021. Additionally, a Step 4 Introductory Training Presentation has also been developed by the Maintenance Expert Working Group.

The objective of this guideline is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. The guideline recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents.

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Questions and Answers on the Principles of GMP for the Manufacturing of Starting Materials of Biological Origin Used to Transfer Genetic Material for the Manufacturing of ATMPs
On 23 April 2021 the EMA announced the availability of the updated Q&A guidance on GMP.

A GMP certificate is not required for manufacturing and testing sites of starting materials for ATMPs. For certain starting materials of biological origin1, (e.g. linear DNA used as template for ex vivo transcription into mRNA, plasmids to generate viral vectors and/or mRNA, and vectors2) used to transfer genetic material for the manufacturing of ATMPs it is, however, mandatory that the principles of GMP are complied with.

This Q&A document doesn’t set new GMP requirements but gives guidance on what principles of GMP mean and how to implement them. To this end, a methodology is described to identify minimal requirements in the fields of quality management system, risk management product development, production and quality control to define the principles of GMP applicable to the relevant starting materials.

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Clinical Trials Information System Reaches Major Milestone towards Go-Live and Application of the Clinical Trial Regulation
On 21 April 2021 the EMA announced that the CTIS is on track to go live with the application of Clinical Trial Regulation.

EMA’s Management Board confirmed that the clinical trial EU Portal and Database, one of the main deliverables of the Clinical Trial Regulation and the key component of the Clinical Trial Information System (CTIS), is now fully functional and on track to go live by 31 January 2022. The Board confirmed that it has verified that the system meets the agreed requirements during an extraordinary meeting held on 21 April following an independent audit of this new IT system.

As a next step, the Board will inform the European Commission of this outcome. Once satisfied that the conditions set by the Clinical Trial Regulation have been met, the European Commission will publish a notice in the Official Journal of the European Union and six months after this publication, the Clinical Trial Regulation will start to apply and CTIS will go live. It is the desire of the Board, EMA and European Commission that the system goes live on 31 January 2022, which would imply that the Commission notice in the Official Journal would be published on 31 July 2021.

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Request for Proposals for Auditors to Support Audits of MedDRA MSSO Operations
On 21 April 2021 the ICH launched a request for proposal for auditors in support of MedDRA MSSO audits.

The ICH MedDRA Management Committee is launching a request for proposals for auditors in support of its multi-year audit plan which includes the following types of audit:

  • Clinical-Quality-Procedural audit;
  • IT audit; and
  • Agreed-Upon-Procedures Financial audit.

At least one of these audits is organised annually, with the MedDRA Management Committee organising further ad hoc audits if it would deem these necessary.

The deadline for responding to the call is 24 June 2021. Further information on how to submit a proposal can be found on the MedDRA page.

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CDISC CDASH SAE Supplement v2.0 Released
On 21 April 2021 the CDISC announced the release of the CDASH SAE Supplement version 2.0.

Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce the release of version 2.0 of the CDASH SAE Supplement, which is now freely available on CDISC’s website. CDASH SAE Supplement v2.0 captures how to structure serious adverse events (SAE) concepts for clinical trials and is aligned with E2B (R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide – Data Elements and Message Specification

The CDASH SAE Supplement v2.0 expands AE and other domains from the CDASH Model v1.1 and its Implementation Guide, CDASHIG v2.1 as well as Controlled Terminology to include additional data elements that capture information in an SAE form, facilitating Sponsor generation of an E2B message for reporting of an ICSR to regulatory authorities.

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Draft Principles of ICH E6 Good Clinical Practice (GCP) now Available
On 19 April 2021 the ICH announced the availability of the draft principles of ICH E6 GCP.

The principles of GCP are designed to be flexible and applicable to a broad range of clinical trials. This guideline, along with ICH E8, encourages thoughtful consideration and planning to address specific and potentially unique aspects of an individual clinical trial. This includes evaluation of trial characteristics, such as the design elements, the investigational product being evaluated, the medical condition being addressed, characteristics of the participants, the setting in which the clinical trial is being conducted, and the type of data being collected. Careful consideration of factors relevant to ensuring trial quality is needed for each clinical trial.

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