​Regulatory and Safety

Innovative approaches to stay ahead of regulatory change.

How can you succeed as demand increases for real world evidence to prove your product's safety and effectiveness? IQVIA is here to help.
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Solutions Real World Evidence Regulatory and Safety
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Expand your options with real world

Increasingly, regulatory authorities are seeing the value of real world evidence (RWE) to evaluate a product’s safety and effectiveness. This changing environment presents you with new opportunities to increase the effectiveness and efficiency of your safety and regulatory studies.

At IQVIA, our global scientific and operational experts are developing innovative approaches for RWE study design and execution. Leverage secondary and primary data directly from patients and physicians to plan the most efficient study design for your needs. Applications include

  • Post-Authorization Safety Studies (PASS)
  • Post-Authorization Effectiveness Studies (PAES)
  • Drug Utilization Studies (DUS)
  • Risk Evaluation and Mitigation Strategy (REMS)
  • EU Risk Management Plan
  • Pregnancy Registries
  • Vaccine Registries
  • Expanded Access Programs (EAPs)
  • Label Expansion Studies

Real world expertise

To best support your research, IQVIA nurtures extensive scientific affiliations and maintains a strong commitment to research excellence. We are active partners and participants with OMOP, ENCePP, EUnetHTA, IMI, the Department of Health and Human Services, and maintain numerous academic affiliations. We help you meet regulatory needs, using RWE to accelerate approvals and label expansions in the U.S. and EU.

Related solutions

Study Design

Use emerging data sources and advances in evidence methods to demonstrate product value and safety.

Making real world reliable

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Safety evidence for regulators - safety evidence pre and post approval

Real world evidence is used by regulators to assess the safety of medicines by analysing data from routine clinical practice to identify, quantify, and monitor risks. It complements clinical trials by providing insight into how drugs perform in broader populations, including rare adverse events and long term outcomes, and supports ongoing benefit–risk evaluation before and after approval.
Regulatory grade safety evidence requires fit for purpose data, appropriate study design, scientific rigor, and transparency in methods and limitations. Regulators assess whether the evidence is reliable and relevant, and expectations may vary by use case. Study design and data choices are often iterative and influenced by regulator feedback.
Engaging regulators on a real world evidence strategy for drug safety involves clearly defining the safety question, selecting fit for purpose data and study design, and presenting a structured justification. Early dialogue is essential, as regulators frequently provide input that shapes study design, data requirements, and evidence acceptability.
Before approval, real world evidence is used to address specific safety questions that cannot be fully answered in clinical trials. This may include understanding real world populations, supporting external comparators, or contextualising safety signals. Early planning and regulator input are critical to ensure the approach, data, and design are fit for purpose and aligned with evidentiary expectations.
After approval, regulators including FDA and EMA require additional safety evidence to further characterise the benefit–risk profile in real world use. This includes Post Authorization Safety Studies (PASS), Post Authorization Effectiveness Studies (PAES), post marketing surveillance programmes, and drug utilisation studies, often as part of formal post marketing commitments.
Post Authorization Safety Studies are designed to identify or quantify safety risks, confirm safety profiles, or evaluate the effectiveness of risk management measures for authorized medicines. They help address evidence gaps that remain after approval and support ongoing benefit–risk evaluation.
Real world evidence supports post market safety by enabling large scale monitoring of real world populations over time. It is used to evaluate rare adverse events, assess safety in specific populations such as pregnant or immunocompromised patients, and determine whether risk minimisation measures are effective in routine clinical practice.
Real world evidence enables long term follow up by supporting efficient monitoring of patients after treatment, particularly for therapies requiring extended observation such as cell and gene therapies. Flexible approaches using secondary data, registries, or hybrid designs help meet regulatory requirements while maintaining feasibility over multi year periods.

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