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.

650
650
Globally registered compounds
5000
5000+
Submissions overseen annually

We currently have over 650 registered compounds globally. Every year, we submit more than 5,000 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 650 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 routinely conduct signal-detection activities for our products (monthly or annually depending on the product) 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.

Likewise, we continuously invest in our pharmacovigilance team and strive to build their capabilities. In 2018, our Egypt pharmacovigilance team successfully completed an advanced training programme on good pharmacovigilance practice (GVP) and pharmacoepidemiology.

As part of our commitment to patient safety and to improving peoples’ lives, we also conducted multiple pharmacovigilance workshops for 450 current and future pharmacists in Jordan and for the National Pharmacovigilance Centre in Iraq.

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 2018, our performance in reporting adverse events and submitting aggregate reports to health authorities within legally-specified timelines remained high at over 98%, which is consistent with industry peers.

Worldwide compliance with pharmacovigilance reporting requirements

2018

2017

Health authority regulatory reporting (cases)

94%

91%

Health authority regulatory reporting (aggregate reports)

98%

98%

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 2018, we were subject to a regulatory inspection in Jordan, which was completed with no major findings. Similarly, recent audits by partners resulted in no major findings.