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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Expediting access through Reliance Pathways: MENA region

Expediting access through Reliance Pathways: MENA region

Reliance models are review pathways used by Regulators to expedite the patient access to essential pharmaceutical products and to overcome resource constraints and priorities. Recently, several National Competent Authorities (NCA) in the Middle East North Africa (MENA) region have implemented the Abridged and Verification reviews. These regulatory procedures allow the approvement of needed innovative and/or life-saving drugs.

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Building Health Literacy: The Value of Good Writing

Building Health Literacy: The Value of Good Writing

Scientists, doctors, and health authorities often use written communication to present their research, opinions, or guidelines to the patients. While the questions they approach may be complex, the language should not. In medical documents, misinterpreted information may endanger the health and life of a patient. Thus, the main goal in medical writing is to convey the message clearly and concisely to avoid misinterpretation.

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CMC: Down the road in effective IND/IMPD writing

CMC: Down the road in effective IND/IMPD writing

In the previous two articles, we have shared our experience on various aspects of effective IND/IMPD CMC writing, considering proper planning, assigning a dedicated CMC writing team, and having effective project management. In addition, we discussed technical writing particulars giving some key messages on document preparation. Now, we will discuss other important points. These are safety, data completeness, and geographical regions.

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