Marketing Authorization Process in Russia

Marketing Authorization Process in Russia

Cultural and language problems are a frequent stumbling block for multinational corporations seeking to register drugs in Russia. Additionally, the Marketing Authorization process in Russia is highly complex, and the paperwork frequently changes as the regulatory framework evolves. However, the...

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Drug Registration in Russia

Drug Registration in Russia

 Overview of drug registration in Russia The Russian pharmaceutical industry is expected to exceed two trillion Russian rubles in 2020, representing a roughly 10% growth over the previous year. Pharmaceutical revenues are expected to reach 2.35 trillion Russian rubles by 2023. It's also worth...

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What is Medical information and Communication?

What is Medical information and Communication?

It is no secret that the evolution of evidence-based medicine and shared decision-making, and novel technologies have transformed how we share information and interact with Healthcare Professionals and Patients. The advances in automation, digitization, real-world evidence & Big Data analysis...

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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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