Pharmacovigilance: The inside track

Sue Overton, MUS Team Administrator, Medicines Use and Safety (SPS)Event 13 October 2021Location Online
Topics: Past EventsRegulatory

The webinar discussed the process for reporting and monitoring pharmacovigilance for post-marketing medicines


13 October 2021



About the event

The webinar explained pharmacovigilance (PV) and its impact on everyday practice.

Why it’s important

It’s important to understand the process of PV to ensure medication events are reported.

What was covered

The webinar covered:

  • An outline of what PV is and its aims.
  • The importance of reporting and communication was discussed, as well as what happens when we make e.g. yellow card reports to the MHRA.
  • Future developments of the system and other initiatives such as genomics.


A range of speakers ran this event from SPS and other organisations.

SPS Speakers

Learn more about SPS team member who are speaking.

Non-SPS speakers

Mitul Jadeja

Special Projects Manager, Vigilance Intelligence & Research.
Vigilance and Risk Management of Medicines (VRMM), MHRA


Access the recording of the webinar


A number of questions were asked during the event by attendees. We’ve liaised with our speakers to summarise those below.

Clinical Trials and PV

If PV is not required in Clinical trials, then how is drug safety data monitored during clinical trials?

Pharmacovigilance is specifically concerned with the safety of medicines post marketing.

Reports of clinical trial safety problems are not meant to be submitted as a Yellow Card.  There are very strict clinical trial protocols which should be followed for clinical trials around the reporting of safety issues e.g. you must report all suspected unexpected serious adverse reactions (SUSARs). Institutions must follow these protocols and such SUSARs are sent to the MHRA. Organisations are required to keep detailed records of all adverse reactions relating to a clinical trial.

Further information on clinical trials is available from the MHRA.

EMIS Yellow Card

Do you know how to use EMIS integrated yellow card?

EMIS has an integrated Yellow Card and a video is available on how to use EMIS to submit a Yellow Card for a suspected adverse drug reaction.

Artificial Intelligence

Which bits of the process are done by humans and which bits by artificial intelligence (AI) / algorithms?

Mitul confirmed that:

  • The AI tool helps by reducing the amount of manual coding for each report, thereby saving resource in processing cases and ensuring they are rapidly available for the clinical and scientific analysis by staff.
  • The tool isn’t used for assessment of data, but to help ensure that all the information from the reporter is well structured to support analysis and subject to robust quality assessment.
  • Nearly all the other steps involve assessment by the team of safety scientists and medics at the MHRA that continuously evaluate Yellow Card reports to detect ‘signals’ of potential safety issues.
  • The data collected from Yellow Card reporting enables the assessment of data on medicines and vaccines to detect previously unrecognised side effects/safety issues associated with current treatments.
  • There are a range of resources and technology to support the safety monitoring. The use of AI is one element of that, which will help structure narrative data, enabling assessors to focus on assessment of data submitted.
  • Every report of a suspected side effect is taken seriously and the individual reports are combined with statistical analysis of clinical records. An established statistical approach is used to facilitate signal detection. Scientific and clinical assessment by staff is  done to determine if an individual or series of reports indicate a new safety ‘signal’ which can be investigated further by the experts.

Reporting known side effects

Should we report known side effects when they occur? Does that help any in the sense of monitoring the frequency of occurrence?

Known side effects should be reported when they occur. There is always more to learn and every report helps us understand what an individual’s risk might be. This understanding helps us mitigate risks for future patients.  Please report all suspected adverse drug reactions that are:

Serious, medically significant or result in harm

Serious events are defined as one of the following:

  • fatal
  • life-threatening
  • a congenital abnormality
  • disabling or incapacitating
  • resulting in hospitalisation
Associated with newer drugs and vaccines (▼)

All reactions to new drugs and vaccines should be reported.

The most up-to-date list of black triangle medicines is available at: (See Newer drugs and vaccines)

Medication errors

Medication errors that cause harm should also be reported.

If in doubt whether to report a suspected adverse drug reaction, please complete a Yellow Card.

More information can be found at the Yellow Card scheme.

Marketing authorisation holders

What national database does MAH need to submit ADRs to?

In the UK, Marketing authorisation holders (MAHs) should submit a signal or an ADR to a medicine, to the MHRA as per the ICSR reporting guidance.

Updating a submitted Yellow Card

If you have a further update on a Yellow Card you’ve submitted (e.g. what treatment worked, or progression of the adverse reaction), how can you advise MHRA of the update without submitting another Yellow Card?

If you have a further update on a Yellow Card that has already been submitted (e.g. what treatment worked, or progression of the adverse reaction), you can email with your reference number so it can be added to the initial your report.


How does MHRA work with EMA now; with regard to sharing/working on pharmacovigilance so we can use the collective information within Europe as a continent?

  • Throughout the Covid-19 pandemic, the MHRA has been working closely with its international counterparts including the EMA to understand the global safety experience of COVID-19 vaccines. Through various Memorandums of Understanding with international regulations, MHRA is able to exchange data globally for purposes in line with our regulatory activities which includes patient safety.
  • With respect to Northern Ireland we are informed of decisions by the EMA but in general pharmacovigilance data needs to be submitted to both MHRA and EMA as applicable. Where a Marketing Authorisation Holder that holds a product licence for a medicine wants us to take into account the EU decision/assessment in our assessment they need to submit the relevant information to us (CHMP opinion, Assessment report etc).

EUDRA database

Do we still have 2-way access to the EUDRA database?

The UK no longer has two-way access to EudraVigilance so all ICSRs originating in the UK need to be submitted to us together with serious reports from third countries. MHRA requirements mean that we have access to all ADR data that will be transmitted to the EMA within our own database which enables robust signal detection across all products used in the UK.

Manufacturers of unlicensed medicines

One delegate enquired about the manufacture of unlicensed medicines. They mentioned that possible ADRs are notified using a Company created form to include additional information on composition of the medicine, which is then emailed to  and if required to They asked of this is a valid approach and Mitul advised the following:

Mitul was unable to comment about specific cases like this but in general, for unlicensed medicines there is a guideline but this was last updated in 2018. It says that reports should be submitted electronically via the EudraVigilance gateway obviously this is out of date. It would be better for the company register for our system and submit the ADRs as outlined in the links above, rather than e-mailing reports to us, but of course if the company is supplying the medicines to Northern Ireland they should also submit them to EudraVigilance.

Yellow Card training

Training on how to complete a Yellow Card is available via the MHRA.

Contact us

Contact the Admin Team if you have any questions