ICH-E2A REPORTING
WHAT IS ICH?
ICH is the “International Conference on Harmonization of Technical requirements for registration of pharmaceuticals for human use”.
ICH is a joint initiative involving both regulators and research-based industry representatives of the EU, Japan, and the US in scientific and technical discussions of the testing procedures required to access and ensure the safety, quality, and efficacy of medicines.
SECTIONS OF ICH :
Quality guidelines
Safety guidelines
Efficacy guidelines
Multidisciplinary guidelines
WHAT IS E2A REPORTING?
E2A reporting comes under the efficacy guidelines of the ICH.
The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety, and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/ pharmacogenomics techniques to produce better-targeted medicines.
Efficacy guidelines are from E1-E21
E2 includes subsections from E2A TO E2F which are the guidelines regarding pharmacovigilance
E2A –Standards for Expedited reporting
The ICH Harmonised Guideline was finalised under Step 4 in October 1994. This document gives standard definitions and terminology for key aspects of clinical safety reporting. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development.
A. What Should be Reported?
1. Single Cases of Serious, Unexpected ADRs:
All adverse drug reactions (ADRs) that are both serious and unexpected are subject to expedited reporting. This applies to reports from spontaneous sources and from any type of clinical or epidemiological investigation, independent of design or purpose. It also applies to cases not reported directly to a sponsor or manufacturer (for example, those found in regulatory authority-generated ADR registries or in publications). The source of a report (investigation, spontaneous, other) should always be specified. Expedited reporting of reactions which are serious but expected will ordinarily be inappropriate. Expedited reporting is also inappropriate for serious events from clinical investigations that are considered not related to study product, whether the event is expected or not. Similarly, non-serious adverse reactions, whether expected or not, will ordinarily not be subject to expedited reporting.
2. Other Observations:
There are situations in addition to single case reports of "serious" adverse events or reactions that may necessitate rapid communication to regulatory authorities; appropriate medical and scientific judgement should be applied for each situation. In general, information that might materially influence the benefit risk assessment of a medicinal product or that would be sufficient to consider changes in medicinal product administration or in the overall conduct of a clinical investigation represents such situations. Examples include: a. For an "expected," serious ADR, an increase in the rate of occurrence which is judged to be clinically important. b. A significant hazard to the patient population, such as lack of efficacy with a medicinal product used in treating life-threatening disease. c. A major safety finding from a newly completed animal study (such as carcinogenicity).
B. Reporting Time Frames
1. Fatal or Life-Threatening Unexpected ADRs
Certain ADRs may be sufficiently alarming so as to require very rapid notification . Regulatory agencies should be notified (e.g., by telephone, facsimile transmission, or in writing) as soon as possible but no later than 7 calendar days after first knowledge by the sponsor that a case qualifies, followed by as complete a report as possible within 8 additional calendar days.
2. All Other Serious, Unexpected ADRs
Serious, unexpected reactions (ADRs) that are not fatal or life-threatening must be filed as soon as possible but no later than 15 calendar days after first knowledge by the sponsor that the case meets the minimum criteria for expedited reporting.
3. Minimum criteria for reporting Information for final description and evaluation of a case report may not be available within the required time frames for reporting outlined above. Nevertheless, for regulatory purposes, initial reports should be submitted within the prescribed time as long as the following minimum criteria are met: an identifiable patient; a suspect medicinal product; an identifiable reporting source; and an event or outcome that can be identified as serious and unexpected, and for which, in clinical investigation cases, there is a reasonable suspected causal relationship. Follow-up information should be actively sought and submitted as it becomes available.
C. How to Report
The CIOMS-I form has been a widely accepted standard for expedited adverse event reporting. However, no matter what the form or format used, it is important that certain basic information/data elements, when available, be included with any expedited report, whether in a tabular or narrative presentation. The listing in Attachment 1 addresses those data elements regarded as desirable; if all are not available at the time of expedited reporting, efforts should be made to obtain them. All reports must be sent to those regulators or other official parties requiring them (as appropriate for the local situation) in countries where the drug is under development.
INFORMING INVESTIGATORS AND ETHICS COMMITTEES/ INSTITUTIONAL REVIEW BOARDS OF NEW SAFETY INFORMATION:
International standards regarding such communication are discussed within the ICH GCP Guidelines, including the addendum on "Guideline for the Investigator's Brochure." In general, the sponsor of a study should amend the Investigator's Brochure as needed, and in accord with any local regulatory requirements, so as to keep the description of safety information updated.
REFERENCE:
https://www.ich.org/page/efficacy-guidelines
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