UAE launches tool to report medicine side effects as new campaign urges residents to speak up

Dubai: The UAE has launched a new smart tool, EDE DAWA, that allows residents to report suspected side effects of medicines and medical products, as the Emirates Drug Establishment (EDE) rolls out a nationwide pharmacovigilance campaign urging people to speak up.

The tool can be accessed by scanning the QR code provided with the campaign. Reports can also be submitted through the EDE website, which has separate pages for individuals and for pharmaceutical facilities.

Developed and approved as part of EDE’s partnership with the Uppsala Monitoring Centre (UMC), the tool is designed to simplify the submission of information and its referral to specialists for review and assessment through established procedures.

The UMC is an independent, non-profit foundation established in 1978 and based in Uppsala, Sweden. It serves as the designated World Health Organization (WHO) Collaborating Centre for International Drug Monitoring.

How to report

As part of efforts to develop reporting channels and make them more accessible, EDE is making its smart "EDE DAWA" tool available during the campaign week.

This will enable members of the public to report potential side effects of medical products.

Individuals can report through the link: Reporting Side Effects of Medicines and Medical Products for Individuals on the EDE portal.

Pharmaceutical facilities can report through: Reporting Side Effects of Medicines and Medical Products for Pharmaceutical Facilities on EDE portal.

EDE called on patients, caregivers and healthcare professionals to report suspected side effects through its designated official channels, one for individuals and patients and another for healthcare professionals and establishments.

Nationwide safety push

The nationwide campaign, titled “Speak Up…Stay Safe”, has been launched in collaboration with the Ministry of Health and Prevention, Emirates Health Services, Dubai Health Authority, Department of Health – Abu Dhabi and Sharjah Health Authority.

It forms part of EDE’s participation in the global MedSafetyWeek 2026, which runs from November 2 to 8. The campaign aims to encourage the reporting of suspected side effects and establish a coordinated approach among health authorities to protect patients and support the safety of medical products.

The campaign coincides with the 11th edition of the global initiative, coordinated by the UMC in collaboration with medicines regulatory authorities, pharmacovigilance centres and international organisations worldwide.

This year’s theme, “Side effects - Don’t ignore them, report them!”, places patients’ experiences at the centre of its messages. It seeks to raise awareness of the value of information provided by individuals and healthcare professionals about suspected side effects during medicine use.

Workshops and seminars

The campaign also clarifies the roles of patients, caregivers, healthcare professionals and pharmaceutical establishments in reporting suspected side effects. These efforts support continued monitoring of medical product safety after marketing authorisation.

The programme includes virtual workshops for healthcare professionals on monitoring medicine safety and managing suspected side effects, as well as awareness visits to the University of Sharjah.

University activities will include introductory lectures on pharmacovigilance and the importance of reporting, alongside sessions to familiarise students with official reporting channels and train them to use these services.

A virtual seminar for the pharmaceutical industry will cover the responsibilities of companies and establishments and pharmacovigilance requirements, helping strengthen knowledge of practices and procedures related to medical product safety.

Safety after approval

Dr Ruqaya Aqeel Al Bastaki, Acting Executive Director of the Medical Products Regulation Sector at EDE, said the campaign aims to promote a regulatory approach that connects public awareness with scientific monitoring and regulatory action.

She stressed that the responsibility of authorities concerned with medicine safety does not end when a product is approved and placed on the market. Rather, it continues throughout the medicine’s lifecycle as information about its use evolves.

Dr Al Bastaki explained that reports of suspected side effects are among the sources of information assessed alongside other scientific evidence. This helps identify potential safety signals that require further investigation and appropriate decisions based on available evidence.

She added that building an effective pharmacovigilance system requires coordinated efforts among regulatory authorities, healthcare professionals and the pharmaceutical industry, alongside the participation of patients and caregivers in sharing relevant information.

Al Bastaki noted that unified national efforts, consistent awareness messages and clearly defined official reporting channels help encourage participation among target groups and strengthen confidence in the regulatory system.

She emphasised that the campaign’s value extends beyond raising awareness to establishing a sustainable practice in which reporting becomes part of the responsible use of medicines.

New national guide

The campaign also carries an additional regulatory dimension following EDE’s approval last July of the “Guide to Controls, Conditions and Good Pharmacovigilance Practices for Pharmaceutical Products”, under Decision No. 27 of 2026 issued by the Chairman of the Board of Directors.

The guide provides a national reference framework defining the responsibilities of relevant entities and the requirements for monitoring and evaluating safety information and managing risks associated with pharmaceutical products after marketing authorisation.

EDE stressed that sharing such information supports efforts to protect public health and promote the safe use of medicines and medical products.