ICH guidelines- Summary of E2D

 ICH guidelines E2D 

POST-APPROVAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING

Any PV professional aiming to work in or already working in ICSR has to be aware on how to navigate and use the ICH E2D guidance.

ICH E2D goes into details about the various scenario's a MAH has to navigate while processing, analyzing and submitting ICSR from post marketing scenario. 

Below are generic timelines, format and content outlined from the guidance document with my interpretations.

Reference:https://database.ich.org/sites/default/files/E2D_Guideline.pdf

1. ICSR content and format: 

• Cases of adverse drug reactions that are both serious and unexpected are subject to expedited reporting. The reporting of serious expected reactions in an expedited manner varies among countries. 
• Non-serious adverse reactions, whether expected or not, would normally not be subject to expedited reporting.
• The definition of life threatening and medically significant should be revised which clearly specifies the criterion for this seriousness criteria.
• Source of case i.e. spontaneous vs solicited are well explained

• CIOMS is accepted format for submission. 

2. Literature

• The frequency of the literature searches should be according to local requirements or at least every two weeks.
• If the product source, brand, or trade name is not specified, the MAH should assume that it was its product, although the report should indicate that the specific brand was not identified. 
• If multiple products are mentioned in the article, a report should be submitted only by the applicant whose product is suspected. The suspect product is that identified as such by the article's author. 

3. Digital media

• MAHs should regularly screen websites under their management or responsibility for potential ADR case reports. 
• MAHs are not expected to screen external websites for ADR information. 
• However, if an MAH becomes aware of an adverse reaction on a website that it does not manage, the MAH should review the case and determine whether it should be reported. 

4. Other pointers

• Medical review should be done for clinical completeness of case, is diagnosis provided, what are diagnostic procedures, what other possible factors could cause this, what more information's is needed?
• Follow up attempt should be made for serious cases . For incomplete cases as well follow up to ensure 4 minimum criteria are seek should be documented. The priority and expectation for follow up is mentioned.

 Written by:

Dr.Shraddha Bhange.

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