Our commitment to patient safety

As a pharmaceutical company, our primary obligation is to ensure our products are as safe as possible for the patients who use them. We gather comprehensive information about our products’ safety so that we can take proactive measures to minimise risks to our patients.

Every medicine has the potential to produce adverse events for patients. Not all adverse events are known at the time of approval of a new medicine. Some may only be discovered post-approval after a medicine has been used by a large number of patients.

Our Approach

The health and safety of our patients is at the heart of what we do. We operate a rigorous pharmacovigilance system to prevent patient harm and to promote the safe and effective use of our products.

We have globally-aligned processes to detect, evaluate and communicate any change to the benefit-risk ratio of our products and to implement timely corrective and preventative actions. We conduct our pharmacovigilance activities globally across the whole lifespan of our products, complying with all local regulations and safety reporting timelines.

When needed in the pre-approval phase, we submit a registration dossier to relevant authorities that includes risk management plans (RMPs) detailing the risk management system proposed to identify, characterise and minimise the safety risks.

Once marketing approval is granted by regulatory authorities, we implement risk minimisation measures and measure their effectiveness. Our RMPs are regularly updated based on new safety information as it becomes available.

Globally registered compounds
Submissions overseen annually

We currently have over 650 registered compounds globally. Every year, we submit more than 6,600 adverse event reports related to our products to health authorities worldwide. We receive the reports from healthcare professionals, consumers, regulatory authorities, literature, studies and social media. 

Similarly, each year we prepare over 720 aggregate reports for our registered compounds. These include periodic safety update reports (PSURs) and periodic adverse drug event reports (PADERs), which provide an up-to-date overview of the product’s safety worldwide and an assessment of its benefit-risk ratio. These reports are submitted at regular intervals to health authorities, who validate that the benefits of our products outweigh their risks and confirm that they remain safe to stay on the market.

We continually monitor for changes to pharmacovigilance requirements to ensure we stay ahead of the regulatory landscape. We also conduct signal detection activities for our products monthly to proactively detect safety issues. Any new safety signals are examined by our Drug Safety Committee (DSC), which decides what further action is needed.

Pharmacovigilance is monitored at the highest levels of our business. It makes up part of our Group enterprise risk management report that is presented to the Executive Committee on a regular basis.

We use the most up-to-date global safety database (ARISg7) to support our process for adverse event management and electronic reporting. This helps ensure that our pharmacovigilance activities remain in compliance with global safety reporting obligations.

We continuously invest in our pharmacovigilance team and strive to build their capabilities. In 2020, the global pharmacovigilance team rolled out a new mandatory eLearning course, Pharmacovigilance 101, to all Hikma employees through our Learning Management System (LMS).

In addition, the global pharmacovigilance team also launched a new Group Pharmacovigilance Policy taking effect 15 July 2020. This policy applies to all Hikma employees. This new policy highlights that all Hikma employees are part of the Hikma Pharmacovigilance system and must report to the PV department any adverse event, adverse drug reaction or other safety report relating to Hikma products as soon as possible, and in all cases not later than one business day.

How we perform

To ensure our pharmacovigilance system is achieving its objectives, we monitor our worldwide compliance metrics every month. These are recorded in monthly operational reports and reviewed in global and regional pharmacovigilance meetings.

In 2020, our performance in reporting adverse events and submitting aggregate reports to health authorities within legally-specified timelines remained high at over 98% and 100%, respectively, which is consistent with industry peers.

Worldwide compliance with pharmacovigilance reporting requirements





Health authority regulatory reporting (cases)





Health authority regulatory reporting (aggregate reports)





Our pharmacovigilance audit strategy ensures that risk-based audits are performed annually in line with our pharmacovigilance audit plan. Audits cover all processes and activities performed by our Global Pharmacovigilance team, affiliates and third parties, such as distributors, service providers and partners. Our pharmacovigilance audit programme helps ensure our compliance with regulations and provides opportunities to continuously improve our existing systems.

In 2020, we audited 3 affiliates and Corporate PV. In addition, we underwent a pharmacovigilance regulatory inspection by the Saudi Food and Drug Authority, and 1 audit from a partner.