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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Saudi FDA’s New Pricing Guidelines and Impact on the Region

Saudi FDA’s New Pricing Guidelines and Impact on the Region

In a highly evolving regional pricing environment, Saudi Arabia (KSA) is no exception. The Saudi Food and Drug Authority (SFDA) has been periodically reviewing its pricing mechanisms and criteria so that the country becomes a regional reference for the prices of pharmaceutical products. What followed is a change in the pricing strategy by SFDA and a shift from price takers to price makers.

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Effective IMPD Writing. The Quality Part

Effective IMPD Writing. The Quality Part

Webinar: Effective IMPD Writing. The Quality Part Effective IMPD writing, including the quality part is a vital document that contains information about an investigational medicinal product and it is an essential part of the Clinical Trial Application (CTA), which is required by competent...

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Challenges in early phase oncology trials
Clinical Trials Regulation
Challenges in early phase oncology trials