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Marketing Authorization Renewal in the MENA Region

Marketing Authorization Renewal in the MENA Region

by Kamile Gruduls | Jul 30, 2021 | Regulatory Affairs

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...
Company Registration Requirements in MENA: a Prerequisite for Product Registration

Company Registration Requirements in MENA: a Prerequisite for Product Registration

by Kamile Gruduls | May 12, 2021 | Regulatory Affairs

Company registration is part of the common regulatory requirements in several Middle Eastern and North African (MENA) countries. Nevertheless, it can be easily overlooked in preparation for drug filing and the overall regulatory picture.  MENA countries are accepting...
Biosimilars in the MENA Region: Regulatory Landscape

Biosimilars in the MENA Region: Regulatory Landscape

by Kamile Gruduls | Apr 27, 2021 | Regulatory Affairs

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...
Expediting access through Reliance Pathways: MENA region

Expediting access through Reliance Pathways: MENA region

by Nick | Mar 16, 2021 | Regulatory Affairs

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...
Drugs serialization and barcoding in Saudi Arabia and MENA region

Drugs serialization and barcoding in Saudi Arabia and MENA region

by Nick | Mar 11, 2021 | Regulatory Affairs

  An increasing number of countries worldwide have enacted regulations mandating serialization, tracking and tracing of pharmaceutical products down the supply chain during recent years as a response to drug integrity concerns. There are plenty of laws requiring...
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