What an adverse event report needs
Short answer
An adverse event report, known as an individual case safety report, is valid only when it has four minimum elements under ICH E2D(R1): an identifiable patient, at least one identifiable reporter, at least one suspect medicinal product and at least one adverse event or reaction. Dates, batch number, seriousness and outcome then make it useful.
Key takeaways
- A valid individual case safety report needs an identifiable patient, an identifiable reporter, a suspect medicinal product and an adverse event or reaction.
- One identifier is enough to make a patient identifiable, for example age, sex, initials or a patient number, so full names are not needed.
- A case is serious if it results in death, is life-threatening, requires or prolongs hospitalisation, causes lasting disability, is a congenital anomaly or is otherwise medically important.
- Marketing authorisation holders must send expedited reports no later than 15 calendar days after they first hold the four minimum elements.
- For imported and named-patient medicines, the batch number and the supply route help the manufacturer and regulator trace the product.
When a patient has a suspected reaction to a medicine, the report that follows is only as useful as the information in it. A report with no patient details, no product name or no description of what happened cannot be processed. A report with the batch number, dates and outcome can help a manufacturer and a regulator find a signal or a quality defect.
This matters even more for medicines supplied under named-patient, special access or comparator routes. The product may not be registered in the destination, few patients may receive it and the manufacturer may have no local office. This guide explains what a valid report needs, what makes it useful, how seriousness and timelines work, and where reports go. It does not give medical advice on managing a reaction.
The four minimum criteria
The international standard is set by ICH. The revised post-approval guideline, ICH E2D(R1), was endorsed under Step 4 on 15 September 2025 and came into effect in the EU on 18 March 2026. It says an individual case safety report must have at least four elements before any regulator can accept it.
| Element | What counts | Practical note |
|---|---|---|
| An adverse event or reaction | At least one event, reaction or other observation, such as a medication error | Describe what happened in plain words |
| A suspect medicinal product | At least one suspect or interacting product | Include brand, active ingredient, manufacturer and batch where known |
| An identifiable patient | One or more of age or age group, gestational age, sex, initials, date of birth, name or patient number | One identifier is enough, so a full name is not needed |
| An identifiable reporter | For example name, initials, organisation, address, email, phone or qualification | The reporter can stay anonymous if it is known that a real person reported |
A case missing any of the four does not qualify yet, and the receiver should follow up to obtain the missing element. A statement such as "several patients had a rash" is not a case until the reaction can be linked to a specific patient.
The clinical trial guideline, ICH E2A, uses the same four elements for expedited reports: an identifiable patient, the name of a suspect medicinal product, an identifiable reporting source and an event or outcome.
What makes a report useful
The minimum criteria make a report valid. The details below make it possible to assess. Many of them match the fields of the CIOMS I form, the international suspect adverse reaction report format.
Patient details
Age, sex, weight, relevant medical history and other conditions. Use initials or a hospital number rather than the full name where local rules allow, which also limits the personal data shared across borders.
Product details
- Brand name, active ingredient, strength and dosage form.
- Manufacturer and country of manufacture.
- Batch number and expiry date, read from the pack.
- Dose, route, frequency, start and stop dates and the reason for use.
- Other medicines taken at the same time, including any started recently.
For an imported or named-patient product, add the supply route, the import approval number and the supplier. This lets the manufacturer trace the batch and check whether other patients received the same lot.
Event details
When the event started, what happened, what was done, and the outcome at the time of reporting, such as recovered, recovering, not recovered, recovered with lasting effects, fatal or unknown. Note whether the event stopped when the medicine was stopped and whether it came back if the medicine was given again. Attach relevant test results.
Seriousness and reporting timelines
What counts as serious
ICH defines a serious adverse event or reaction as one that, at any dose:
- results in death
- is life-threatening, meaning the patient was at risk of death at the time
- requires inpatient hospitalisation or prolongs an existing stay
- results in persistent or significant disability or incapacity
- is a congenital anomaly or birth defect
- is an important medical event that may need intervention to prevent one of the outcomes above
Serious is not the same as severe. A severe headache can be non-serious, while a moderate reaction that leads to admission is serious.
How fast reports move
| Situation | Maximum time | Source |
|---|---|---|
| Marketed product, case that meets expedited criteria, usually serious and unexpected | 15 calendar days after day zero | ICH E2D(R1) |
| Clinical trial, fatal or life-threatening unexpected reaction | 7 calendar days, with a complete report within 8 more days | ICH E2A |
| Clinical trial, other serious unexpected reaction | 15 calendar days | ICH E2A |
| Non-serious reactions | Set by regional and local rules | ICH E2D(R1) |
Day zero is the date when anyone working for the marketing authorisation holder, including a contracted third party, first holds the four minimum elements. When new medically relevant information arrives, the clock starts again for the follow-up report. That is why a distributor or supplier that receives a report should pass it on the same day. National rules for hospitals and physicians differ, and some import approvals set their own reporting duties.
Preparing a report step by step
The steps below suit a hospital pharmacy, a clinical team or an importer that receives news of a suspected reaction. They are about the paperwork only, not about the patient's care.
- Capture the four minimum elements first. Note who reported, who the patient is in coded form, which product is suspected and what happened, even if nothing else is known yet.
- Read the pack. Record the brand, strength, manufacturer, batch number and expiry date directly from the pack the patient used, and keep that pack.
- Record the timeline. Write down when the product was started and stopped, when the event began and what was done.
- Assess seriousness. Check the event against the seriousness criteria and record the outcome so far.
- Use the right form. Use the national regulator's form or online system, or the CIOMS I format when the report goes to a company.
- Send it to everyone who needs it. Follow the national rules and the conditions of the import approval, and tell the manufacturer and the supplier.
- Send follow-up information. Add test results, the final outcome and any new details as a follow-up report, quoting the first report's reference.
Where reports go
- The national regulator or pharmacovigilance centre in the country where the patient was treated, using its own form or online system.
- The marketing authorisation holder or manufacturer, which collects safety data worldwide even where the product is not registered.
- The supplier, which can trace the batch, hold remaining stock and pass the report to the manufacturer.
- The ethics committee and sponsor, where the product was used in a clinical trial.
India's pharmacovigilance programme
For products made in India, reports from abroad normally go to the manufacturer, which runs its own safety system. Within India, the Pharmacovigilance Programme of India (PvPI) is run by the Indian Pharmacopoeia Commission as its national coordination centre. According to the PvPI FAQ, healthcare professionals and patients can report, using the suspected adverse drug reaction form or the consumer side-effect form, through adverse drug reaction monitoring centres, by email, through the ADR PvPI app or through the toll-free helpline 1800-180-3024, which runs Monday to Friday. Published sources do not set out PvPI duties for exporters or traders as distinct from manufacturers.
Adverse events and quality complaints
A reaction can be caused by the medicine itself or by a defect in a particular pack. Keep the pack, the remaining product and the shipping documents, and record any change in appearance, a broken seal or a temperature excursion. A suspected falsified or substandard product should also be reported as a quality complaint. WHO publishes confirmed cases on its medical product alerts page.
The guide to avoiding falsified medicines covers pack checks, and the temperature excursion guide explains how to read a logger record. For the route itself, see the guides on named-patient supply and comparator sourcing for clinical trials.
This page explains how regulatory routes work. It is not legal or medical advice. Confirm current requirements with the regulator or a local agent before goods ship.
Questions and answers
What are the minimum criteria for a valid adverse event report?
ICH E2D(R1) lists four: at least one adverse event or reaction, at least one suspect or interacting medicinal product, an identifiable patient and at least one identifiable reporter. A case missing any of them does not qualify for reporting yet, and the receiver should follow up to collect what is missing.
Can a reporter stay anonymous?
Yes. ICH E2D(R1) says a report should still be submitted when the reporter wishes to remain anonymous, as long as it is known that a real person reported it and the case otherwise meets the requirements.
How fast must a serious adverse event be reported?
For marketed products, ICH E2D(R1) sets a maximum of 15 calendar days for expedited reports after the marketing authorisation holder has the minimum information. Hospitals and physicians follow their national rules and the conditions of the import approval, which can be shorter.
Is the CIOMS I form mandatory?
No. It is a standard international format for suspect adverse reaction reports, used especially for reports sent between companies and regulators. National regulators have their own forms and online systems, and those should be used where they apply.
Who should a hospital tell after a reaction to an imported unlicensed medicine?
The national pharmacovigilance centre or regulator, under its rules and the conditions of the import approval, and the manufacturer or marketing authorisation holder. Telling the supplier as well helps trace the batch and any other stock from it.
References
- 1.EMA, ICH E2D(R1) guideline on post-approval safety data management (EMA/CHMP/ICH/59123/2024)
- 2.ICH, E2A clinical safety data management, definitions and standards for expedited reporting
- 3.CIOMS, CIOMS I form for suspect adverse reaction reports
- 4.Indian Pharmacopoeia Commission, PvPI frequently asked questions
- 5.Indian Pharmacopoeia Commission, PvPI helpline 1800-180-3024 with multilingual voice system
- 6.WHO, Full list of WHO medical product alerts
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