Marketing Authorization Renewal in the MENA Region

Marketing Authorization Renewal in the MENA Region

Regulatory Authorities across the MENA region indicate a specific validity period for the Marketing Authorization Approval certificate of pharmaceutical products that ranges between four to five years in most countries. The purpose behind this license validity period is to enforce the regulation...

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How to register a Medical Device in the EAEU

How to register a Medical Device in the EAEU

Since the establishment of the Eurasian Economic Union in 2015, a significant change is quickly coming into life: a new regional registration system for medical devices is coming into effect from the start of 2022. As most registrations are completed through national procedures, the upcoming...

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Pharmacovigilance: latest news, trends, and insights

Pharmacovigilance: latest news, trends, and insights

During the last years, there has been a skyrocketing demand for pharmacovigilance as medicinal products consumption is growing and disorders and diseases are becoming more prevalent. To top this, an increasing number of adverse drug reactions (ADRs) is becoming a significant concern leading to the...

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Setting Up A Pharmacovigilance System

Setting Up A Pharmacovigilance System

Setting Up a Pharmacovigilance System from Scratch In the EU/EEA, US, and other major pharmaceutical markets, you need a sound plan for post-market surveillance for your medicinal product's Market Authorization Application (MAA). A robust pharmacovigilance (PV) system consists of a safety...

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Centralized Procedure in the GCC Region

Centralized Procedure in the GCC Region

The Centralized Procedure in the GCC Region describes the possibility to register pharmaceutical products throughout the region. The Cooperation Council for the Arab States of the Gulf, abbreviated as "GCC" for "Gulf Cooperation Council", came to exist on May 25th, 1981. The founding Member States...

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Biosimilars in the MENA Region: Regulatory Landscape

Biosimilars in the MENA Region: Regulatory Landscape

Regulatory affairs for biosimilars in Middle East North Africa (MENA) region are evolving as existing guidelines and regulatory frameworks are being updated. Since European Medicines Agency (EMA) introduced a legal pathway for biosimilars approval in 2004, several global agencies, e.g., WHO, MHRA,...

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