PRA Consultancy

**OTC Products in the GCC: When Accessibility Increases Regulatory Risk**

Easy access doesn't mean lower regulatory requirements.

As GCC authorities strengthen oversight of OTC products, companies must navigate evolving regulations, labeling requirements, and compliance expectations to avoid costly delays and market risks.

Read our latest blog to learn what every OTC product manufacturer and distributor should know.

Read the full article here: https://pra-me.com/otc-products-in-the-gcc-when-accessibility-increases-regulatory-risk/

Disinfectants in UAE are no longer treated as “simple hygiene products".

One of the biggest regulatory challenges remains classification.

In UAE, the same product may follow different regulatory pathways depending on:
- Intended use
- Active ingredients
- Healthcare vs consumer application
- Marketing claims

A surface cleaner promoted for “daily hygiene” may face very different requirements from a product positioned for medical disinfection or infection control.

In disinfectants, the right regulatory pathway starts with the right classification.
PRA Consultancy helps healthcare companies navigate compliance with confidence: www.pra-me.com

كل عام وأنتم بخير بمناسبة حلول العام الهجري الجديد 1448 ، ونسأل الله أن يعيده عليكم بالخير واليمن والبركات.

As we welcome the beginning of a new Hijri year of 1448, we extend our warmest wishes to our clients, partners, colleagues, and community

#1448هـ

Celebrating Another Successful Graduation!

We are proud to congratulate the graduates of:

- Regulatory Affairs (RA) GCC Certificate Program | Batch No. 20
- Pharmacovigilance (PV) | GCC Certification Program | Batch No. 13

This marks the completion of an important milestone in their professional journey. Through dedication, hard work, and a commitment to excellence, these participants have successfully completed their training and enhanced their expertise in GCC regulatory affairs and pharmacovigilance.

At PRA Consultancy, our goal is to support healthcare and regulatory professionals in building the knowledge and skills needed to navigate the evolving regulatory landscape across the GCC region.

We extend our heartfelt congratulations to all graduates and wish them continued success in their careers.

Your achievement is a testament to your determination and passion for professional growth.

Dubai Medical University

More than 50% of post-market compliance issues are linked to poor change control management.

Across pharmaceuticals and medical devices, companies continue to face regulatory findings due to unreported variations, delayed notifications, and inconsistent documentation updates.

Regulators are increasingly assessing how efficiently organizations manage change across the product lifecycle.

Compliance is no longer static. It’s operational.

www.pra-me.com

Access & Expand to Egypt with the PRA Consultancy!

Egypt is one of the region’s fastest-growing healthcare markets, offering major opportunities for pharmaceutical, medical device, cosmetics, and healthcare companies. But successful entry requires deep understanding of local regulations, registration pathways, and market access requirements.

At PRA Consultancy, we help companies navigate the Egyptian market with tailored Regulatory Affairs and Market Access support designed to simplify expansion and accelerate approvals.

From regulatory strategy to market entry planning and compliance guidance, our team provides end-to-end assistance to help businesses enter Egypt efficiently and confidently.

Expand your regional presence with PRA Consultancy: www.pra-me.com

GLP-1 products are reshaping regulatory pressure across the GCC.

The rapid growth of GLP-1 products for diabetes and weight management is pushing health authorities to tighten oversight on imports, advertising claims, online promotion, and supply chain monitoring.

For instance, in the UAE, the market offers a pill-based alternative to injectable GLP-1 drugs since 2020 (Approved by the - EDE) .

Global demand has already triggered shortages, parallel trade concerns, and increased scrutiny around counterfeit products.

Regulators are now focusing not only on approval; but on market control, pharmacovigilance, and ethical promotion practices.

For more information about GLP-1 products regulations in the GCC, kindly contact us: www.pra-me.com

Enhance your Pharmacovigilance expertise with our Quality Pharmacovigilance Audit Training Course.

Acquire practical expertise in Pharmacovigilance quality management, audit readiness, and regulatory compliance to ensure inspection preparedness and operational excellence.

• Dates: June 18 July – July 26, 2026
• Attendance: Online

Register Now: https://pra-me.com/quality-pharmacovigilance-audit-training-2/