PRA Consultancy

19/10/2026

Medical Device Changes: Understanding EDE Regulatory Requirements in the UAE:

A medical device change may look operational, but it can become a regulatory action.

In the UAE, Emirates Drug Establishment provides a Minor Variation pathway for registered medical devices, highlighting an important lifecycle consideration: changes to an approved device should be assessed for their regulatory impact before implementation.

Whether the change involves manufacturer information, labelling, intended use, or technical documentation, understanding its regulatory implications is essential.

Before implementing a change, regulatory teams should ask:
- Does the change affect the approved registration or technical documentation?
- Is an amendment or regulatory submission required by EDE?
- Is prior regulatory approval necessary before implementation?
- What supporting documentation or evidence is required?

Depending on the nature of the change, EDE may require supporting documentation and, where applicable, evidence of approval from the competent authority in the country of origin.

The key principle: Assess first. Implement second.

At PRA Consultancy we support medical device manufacturers with regulatory change assessments, variation requirements, and lifecycle management across the UAE, GCC, and MENA.

Connect with our regulatory experts: www.pra-me.com

15/10/2026

PRA Consultancy, in collaboration with the Embassy of the United Arab Emirates in Moscow , successfully concluded an insightful webinar dedicated to Russian pharmaceutical companies and manufacturers exploring opportunities in the UAE market.

The session provided a practical overview of the UAE pharmaceutical landscape, highlighting key regulatory requirements, market entry pathways, and opportunities for pharmaceutical companies looking to establish and expand their presence in the UAE.

We extend our sincere appreciation to the Embassy of the UAE in Moscow for their valuable collaboration and to all participants for their engagement and interest.

At PRA Consultancy, we remain committed to bridging international markets, facilitating regulatory knowledge exchange, and supporting pharmaceutical companies in navigating the evolving UAE healthcare landscape.

15/10/2026

“No major complaints so far. We’re good!”

Sounds reassuring, right? But what if we're missing something?

Same product. Same warning signs. Two very different paths.

In one, the signals are overlooked. Small concerns go unnoticed until they become bigger problems.

In the other, someone pays attention. The signals are monitored, investigated, and acted upon before risks escalate.

So, what made the difference?

Not the product. Not the complaints.

Pharmacovigilance.

Because sometimes, what matters most isn't what has been reported, but what we do with the information we already have.

12/10/2026

How should patents be approached when registering generic drugs with the ?

Patent considerations can be an important part of the regulatory pathway for generic medicines, requiring applicants to understand the applicable requirements and their implications during registration.

In RAYA’s latest explainer video, we break down the SFDA approach to dealing with patents when registering generic drugs and highlight key points applicants should be aware of.

Watch the full explainer with RAYA to learn more: https://youtu.be/SQ2uiqpjGjA

How should patents be approached when registering generic drugs wit...

12/10/2026

The Emirates Drug Establishment (EDA) has introduced the Third-Party Logistics (3PL) storage model for the first time, creating a more flexible pathway for establishments seeking distribution privileges in the UAE.

Under the new model, companies can:

- Contract with an existing medical warehouse licensed by EDE instead of establishing and operating their own independent storage facility.

- Utilize compliant existing warehouse capacity for the storage and distribution of medical products.

- Apply for the related licensing pathway through EDE’s medical warehouse licensing services.

EDE requires applicants using the 3PL model to contract with at least one licensed 3PL provider and has begun conducting inspections while updating the framework and related checklists.

The model aims to reduce operational costs, improve warehouse utilization, support supply chains, attract investment, and strengthen regulatory compliance.

Considering the 3PL model for your UAE operations?

PRA Consultancy can support you throughout the regulatory journey, and provide tailored solutions for those looking to establish, license, and implement their operations successfully and compliantly.

Discover how PRA can support your needs: www.pra-me.com

08/10/2026

The EDE, Emirates Drug Establishment , has introduced the Third-Party Logistics (3PL) storage model for the first time, creating a more flexible pathway for establishments seeking distribution privileges in the UAE.

Under the new model, companies can:

- Contract with an existing medical warehouse licensed by EDE instead of establishing and operating their own independent storage facility.

- Utilize compliant existing warehouse capacity for the storage and distribution of medical products.

- Apply for the related licensing pathway through EDE’s medical warehouse licensing services.

EDE requires applicants using the 3PL model to contract with at least one licensed 3PL provider and has begun conducting inspections while updating the framework and related checklists.

The model aims to reduce operational costs, improve warehouse utilization, support supply chains, attract investment, and strengthen regulatory compliance.

Considering the 3PL model for your UAE operations?

PRA Consultancy can support you throughout the regulatory journey, and provide tailored solutions for those looking to establish, license, and implement their operations successfully and compliantly.

Discover how PRA Consultancy can support your needs: www.pra-me.com

29/09/2026

Today at 2026, Dr. Al Shezawy, Co-Founder & Managing Director of PRA Consultancy and Co-Chairman of AfriSummit 2026, opened the day, welcoming participants to another day of insightful discussions, knowledge exchange, and regulatory collaboration in Kenya.

Throughout the day, Dr. Mona Al Moussli, Co-Founder & Managing Director of PRA Consultancy and Chairman of AfriSummit 2026, joined Dr. Najiba and the rest of the PRA Consultancy team of experts in sharing experiences, exchanging knowledge, and connecting with regulatory professionals, industry leaders, and experts from across Africa and beyond.
As the Strategic Partner of AfriSummit 2026, PRA Consultancy is proud to be part of these important conversations and to contribute to stronger regulatory collaboration between Africa, the GCC, MENA, and global markets.

We look forward to more insightful sessions, valuable exchanges, and meaningful connections in the days ahead.

www.pra-me.com

28/09/2026

Today, Pharmaregafrisummit 2026 brought together leadership, vision, and a shared commitment to advancing healthcare and strengthening regulatory collaboration across Africa.

We were proud to have Dr. Mona Al Moussli, Co-Founder & Managing Director of PRA Consultancy and Chairman of AfriSummit 2026, alongside Dr. Najiba Al Shezawy , Co-Founder & Managing Director of PRA Consultancy and Co-Chairman of AfriSummit 2026, take part in the summit’s opening, together with the PRA Consultancy team, in Kenya.

As the Strategic Partner of AfriSummit 2026, being part of the summit reflects our commitment to strengthening regulatory collaboration, exchanging expertise across markets, and contributing to the continued development of the healthcare and life sciences landscape across Africa, the GCC, and MENA.

We look forward to the days ahead at AfriSummit 2026 and to connecting with regulatory leaders, industry experts, and partners from across the region.

www.pra-me.com

25/09/2026

This World Pharmacists Day, we celebrated the pharmacists behind PRA Consultancy and the journeys that have shaped where they are today.

Studying pharmacy was just the first step, which is why we invited our team to share where that first step has taken them, highlighting the many opportunities and career paths that can grow from a foundation in pharmacy.

From different roles and experiences to different areas of healthcare and the pharmaceutical industry, each journey is unique, but they all started from the same place.

Today, we are proud to celebrate our pharmacists, their individual journeys, and the contributions they continue to make every day as we recognize this year’s theme: “Empowering pharmacists for healthier futures.”

Happy World Pharmacists Day!

22/09/2026

REGULATORY ALERT | UAE:

“EDE Warns Against Unauthorized Exosome & PDRN Medical Products”:

The Emirates Drug Establishment (EDE) has issued a regulatory warning regarding the circulation and use of unauthorized medical products marketed as containing Exosomes and/or PDRN.

The warning covers products promoted for cosmetic, regenerative, or therapeutic purposes, including use through injection, mesotherapy, Dermapen, microneedling, and other invasive procedures.

EDE highlights that the quality, sterility, purity, effectiveness, and safety of unauthorized products cannot be assured and advises healthcare professionals and facilities to discontinue their use and take the required regulatory actions.

For the public, EDE advises against undergoing procedures involving Exosome or PDRN products unless the product's regulatory status and proposed use have been verified.

For more information on this warning alert, contact us: www.pra-me.com