MedDRA
ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1
The completed comments form should be sent to
- The completed comments form should be sent to
[email protected]
*For more information please refer to Public consultation explanatory note: Proposed E2B(R3) updates
to align with ICH E2D(R1) guideline. - 18
July 2003E2D
Approval by the Steering Committee under Step 4 and
recommendation for adoption to the three ICH
regulatory bodies. - 12
November 2003New
Codification
November
2005
E2DE2D
Revision of E2D
CodeHistory
E2D(R1) Endorsement by the Members of the ICH Assembly
under Step 2 and release for public consultation. - Date
New
Codification5 February 2024
E2D(R1)
POST-APPROVAL SAFETY DATA:
DEFINITIONS AND STANDARDS FOR MANAGEMENT AND
REPORTING OF INDIVIDUAL CASE SAFETY REPORTS
E2D(R1)
ICH Consensus Guideline
Table of Contents
1. - The ICH E2D guideline provides guidance on definitions and standards for post-
5
approval individual case safety reporting, as well as good case management practices.
- Detailed guidance on the
9
specific structure, format, standards, and data elements for transmitting Individual Case Safety
10
Reports (ICSRs) is provided in the ICH E2B guideline.
- Guidance on periodic reporting of
11
aggregated safety data is covered in the ICH E2C guideline.
- 12
This guideline provides recommendations that are harmonised to the extent possible given
13
differences in post-market safety reporting requirements among ICH regions.
- 25
2.1.2
Adverse Drug Reaction (ADR)
26
Adverse drug reactions, as defined by local and regional requirements, concern noxious and
27
unintended responses to a medicinal product.
- 66
Product labelling may include information related to ADRs for the pharmaceutical class to
67
which the medicinal product belongs.
- In some cases, ?other observations? can occur
78
without any associated AEs/ADRs, while in other cases ?other observations? can occur with
79
an associated AE/ADR.
- 84
For the purpose of reporting, requirements in some regions refer only to ADRs, whereas other
85
regions refer to AEs.
- 86
Refer to local and regional requirements for specifications and requirements on the reporting
87
of AEs or ADRs to each Regulatory Authority.
- 89
2.2
90
An ICSR is a description of an AE/ADR or other observation in an individual patient at a specific
91
point of time.
- Cases missing any of the above criteria do not qualify for reporting; due diligence
99
should be exercised to collect the missing criteria.
- 6
104
An ICSR can be a description of at least one AE/ADR, or other observation (see Section 5.1.3,
105
Other Observations), or both.
- Primary sources, often referred
112
to as ?reporters?, include healthcare professionals and consumers who provide facts about a case
113
to the MAH or regulatory authority.
- 127
2.7
128
A digital platform is the software and technology used to enable transmission of information
129
between users (see Section 4.3, Digital Platforms).
- Expedited Report
Primary Source
Healthcare Professional (HCP)
Consumer
Digital Platform
7
130
2.8
131
An organised data collection system (ODCS) is an activity that gathers data in a planned manner,
132
thereby enabling review to be performed.
- MAHs should also follow the
286
advice in Section 5.1.2, Important Safety Findings, about communicating safety findings to
13
287
regulatory authorities.
- MAHs may conduct an MRP
395
using a digital platform; in this situation the ICH E2B data element value for ?MRP? should be
396
selected.
- 564
Terms (e.g., AEs/ADRs, indication, and medical conditions) in the narrative should be accurately
565
reflected in appropriate ICH E2B data elements.
- 638
Regulatory Authorities and MAHs should consider and manage duplicates when reviewing
639
pharmacovigilance data, as duplicates negatively impact signal detection.
- 651
Duplicate detection relies on good quality data and is generally based on similarities but should
652
take into account that information in ICSRs may differ between reporters.
EudraVigilance - EVWEB user manual
Dr.Evidence® Launches Breakthrough Regulatory Intelligence Solution
Dr.Evidence , the preeminent evidence-based insights platform for life sciences companies, today announced the launch of a groundbreaking new regulatory intelligence solution.
- Dr.Evidence , the preeminent evidence-based insights platform for life sciences companies, today announced the launch of a groundbreaking new regulatory intelligence solution.
- Building on the company’s industry gold standard label intelligence solution, DocLabel, as well as its next generation scientific literature search engine, this new offering marks a significant advancement in regulatory support for the life sciences industry.
- Dr.Evidence’s regulatory intelligence solution enables users to query health authority documents via a range of filters to provide rapid insights into past submissions and related communications.
- “The new Regulatory Intelligence solution from Dr.Evidence represents a significant step forward in driving efficiencies for regulatory teams,” stated Hayley Parker, PhD., Vice President, Global Regulatory Affairs, PepGen Inc. “The ability to quickly and easily interrogate detailed health authority documents can accelerate our ability to develop effective strategies.”
Rose Higgins, CEO of Dr.Evidence, commented, “We are committed to revolutionizing how the life sciences industry approaches regulatory intelligence.
ResoluteAI integrates IEEE Metadata into its Foundation Scientific Research Platform
ResoluteAI, the research platform for science, announced today the addition of metadata from IEEE peer reviewed content to its Foundation service .
- ResoluteAI, the research platform for science, announced today the addition of metadata from IEEE peer reviewed content to its Foundation service .
- This represents approximately 30% of the worlds literature in the electrical and electronics engineering and computer science fields, making IEEE an invaluable resource for scientific research across multiple industries.
- We believe access to this information for our Foundation customers will be of tremendous value, said Steve Goldstein, CEO of ResoluteAI.
- IEEE peer-reviewed journals and conference proceedings are now discoverable within the ResoluteAI platform , enabling IEEE subscribers to link through to access the full-text at the IEEE Xplore digital library.
ResoluteAI Announces the Integration of New Ontologies, Taxonomies, and Controlled Vocabularies for More Precise Research and Serendipitous Discovery
ResoluteAI, the research platform for science, announced today the integration of seven new ontologies, taxonomies, and controlled vocabularies (OTCVs) to the tagging and classification process on Foundation , its flagship scientific research product.
- ResoluteAI, the research platform for science, announced today the integration of seven new ontologies, taxonomies, and controlled vocabularies (OTCVs) to the tagging and classification process on Foundation , its flagship scientific research product.
- We believe the scientific research process can be significantly enhanced and accelerated by giving users enriched data, said Steve Goldstein, CEO of ResoluteAI.
- These additional ontologies, taxonomies, and controlled vocabularies will dramatically improve our users research capabilities and increase opportunities for serendipitous scientific discovery, Goldstein continued.
- Combined with our interactive analytics and downloadable visualizations, ResoluteAI helps make connections that lead to breakthrough discoveries.
Next-Generation Rett Syndrome Global Registry Designed to Unify Disparate Patient Data to Support Clinical Development Receives Positive Feedback from FDA
"The FDA guidance will help to ensure our database can support clinical development and approval of novel therapeutics as we intend."
- "The FDA guidance will help to ensure our database can support clinical development and approval of novel therapeutics as we intend."
- The Rett Syndrome Global Registry will take a new approach to understanding Rett syndrome by unifying patient data captured from a variety of sources into a single, clinical trial-grade registry.
- The Rett Syndrome Global Registry is a key component of RSRT's plan to cure Rett syndrome by incubating and expediting curative treatment development programs for biopharmaceutical companies, and facilitating the drug approval process.
- Currently in beta testing, the Rett Syndrome Global Registry will be available to the Rett syndrome community in early 2022.
More Than 50 Companies Modernizing Pharmacovigilance with Veeva Vault Safety Suite
PLEASANTON, Calif., Oct. 13, 2021 /PRNewswire/ -- Veeva Systems (NYSE: VEEV) today announced that more than 50 organizations are adopting Veeva Vault Safety Suite applications to simplify case processing and management.
- PLEASANTON, Calif., Oct. 13, 2021 /PRNewswire/ -- Veeva Systems (NYSE: VEEV) today announced that more than 50 organizations are adopting Veeva Vault Safety Suite applications to simplify case processing and management.
- Organizations of all sizes are modernizing pharmacovigilance with the Vault Safety Suite to drive end-to-end processes through better collaboration.
- "More companies are adopting Veeva Vault Safety Suite applications to drive faster, more efficient case management," said Kelly Traverso, vice president, Veeva Vault Safety strategy.
- TheVeeva Vault Safety Suite includes Veeva Vault Safety and Veeva Vault SafetyDocs to manage end-to-end drug safety processes.
More Than 50 Companies Modernizing Pharmacovigilance with Veeva Vault Safety Suite
BARCELONA, Spain, Oct. 13, 2021 /PRNewswire/ -- Veeva Systems (NYSE: VEEV) today announced that more than 50 organizations are adopting Veeva Vault Safety Suite applications to simplify case processing and management. A growing number of emerging biotechs and large enterprises, including a top 20 global pharmaceutical company, are bringing together pharmacovigilance data and content for real-time safety management.
- BARCELONA, Spain, Oct. 13, 2021 /PRNewswire/ -- Veeva Systems (NYSE: VEEV) today announced that more than 50 organizations are adopting Veeva Vault Safety Suite applications to simplify case processing and management.
- Organizations of all sizes are modernizing pharmacovigilance with the Vault Safety Suite to drive end-to-end processes through better collaboration.
- "More companies are adopting Veeva Vault Safety Suite applications to drive faster, more efficient case management," said Kelly Traverso, vice president, Veeva Vault Safety strategy.
- TheVeeva Vault Safety Suite includes Veeva Vault Safety and Veeva Vault SafetyDocs to manage end-to-end drug safety processes.
A new collaboration between SNOMED International and ICH promotes seamless data exchange in support of public health
Developing interoperability between SNOMED CT and MedDRA has been a long-standing ambition and will greatly enhance data collection for regulatory purposes and for drug safety research\xe2\x80\x9d.\nSNOMED International CEO, Don Sweete, welcomes the evolution of the organization\xe2\x80\x99s relationship with ICH.
- Developing interoperability between SNOMED CT and MedDRA has been a long-standing ambition and will greatly enhance data collection for regulatory purposes and for drug safety research\xe2\x80\x9d.\nSNOMED International CEO, Don Sweete, welcomes the evolution of the organization\xe2\x80\x99s relationship with ICH.
- We play an essential role in improving the health of humankind by determining standards for a codified language that represents groups of clinical terms.
- We are committed to the rigorous evolution of our products and services, to deliver continuous innovation for the global healthcare community.
- SNOMED International is the trading name of the International Health Terminology Standards Development Organisation.\nTo learn more about SNOMED International and SNOMED CT, visit www.snomed.org .\nThe International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international non-profit organisation unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.