The much-anticipated MedSafetyWeek – now in its tenth year – is here! This year’s theme, “We can all help make medicines safer,” highlights the collective role we play in ensuring medicine safety.

By reporting suspected adverse reactions to medicines and vaccines, and by flagging potential issues with medical devices or other healthcare products through the Yellow Card scheme, everyone, from patients to healthcare professionals, can help to make medicines safer.

Pharmora Joins the Conversation

As part of this global initiative, our team at Pharmora have been reflecting this week, on how our work contributes to making medicines safer.

This started on Monday with a presentation by Sri Boddu, one of our scientists. She shared insights with the medical team on the recently published updated ICH E2D(R1) guideline (September 2025). The session focused on how the updated guidance strengthens global pharmacovigilance practices, and we discussed the potential impacts on the different stakeholders. See our summary below.

🔍 Key Updates from ICH E2D(R1)

• Digital vigilance: Monitoring now extends to digital platforms, including social media, websites, internet forums, chat rooms, mobile health tools, and apps.
• Clearer definitions: Terms such as Adverse Event, Adverse Drug Reaction, and Serious or Unexpected cases are now more clearly defined, enhancing communication between healthcare professionals and regulators.
• Improved reporting clarity: The guideline explains how to manage both spontaneous and solicited reports effectively.
• Global harmonisation: Recommendations have been aligned across ICH regions, allowing greater consistency in post-market safety reporting.

🌍 Impact on Key Stakeholders

Healthcare Professionals

• The refined terminology and updated reporting processes support more accurate reporting of adverse events, making it easier for safety concerns to be evaluated.

Pharmaceutical Companies / Marketing Authorisation Holders (MAHs)

• The guideline reinforces consistent global practices in collecting, reviewing, analysing, and reporting safety data.
• It helps maintain compliance and strengthens benefit-risk management by promoting timely safety data submissions to regulatory authorities.
• It also enhances case management practices such as handling duplicate reports, verifying patient/reporter identifiability, managing literature and outcome-only reports, and ensuring data integrity.
• There is a workload impact as companies will need to review all of their platforms to determine whether they fulfil the definition of an Organised Data Collection System, and update their procedural documents accordingly.

Regulatory Authorities

• Encourages greater harmonisation across regions, making global safety evaluations more consistent and collaborative.

Patients

• This guideline brings safety surveillance up to date by standardising the monitoring of platforms that patients currently use to report safety concerns.
• With proactive safety monitoring of these platforms and harmonised reporting, patients benefit from faster detection of adverse reactions.
• Standardisation with clarity on terminology and reporting processes should mean higher quality reports and clearer communication of relevant factors, leading to improved risk minimisation measures.

At Pharmora, we are proud to support our clients in their efforts to make medicines safer!