Morocco’s pharmaceutical market is growing, making it a strategic hub for global pharmaceutical and life sciences organizations. However, successful operation hinges on meticulous adherence to the country’s specific drug safety regulations. For Marketing Authorization Holders (MAHs), establishing a robust, locally compliant Pharmacovigilance (PV) Services in Morocco is not just a requirement—it’s a necessity for patient safety and market continuity.
DDReg Pharma is your trusted partner, offering specialized, end-to-end PV services designed to meet the rigorous standards set by Morocco’s health authorities.
The Moroccan PV Landscape: Key Regulatory Bodies
Morocco operates a clear, multi-tiered national pharmacovigilance system overseen by the Ministry of Health. Understanding these key players is fundamental to compliance:
-
National Pharmacovigilance Centre (CNPV): This is the core operational body. The CNPV is responsible for overseeing the processing and management of Adverse Drug Reactions (ADRs), maintaining the national ADR database, coordinating signal detection, and implementing risk minimization measures.
-
National Pharmacovigilance Committee (CNP): This committee provides advisory roles on major drug safety decisions submitted to the Ministry of Health.
-
Technical Committee (CTPV): This committee offers scientific and technical assistance to the CNPV, conducting necessary PV investigations.
Compliance is mandatory for all Healthcare Professionals and Marketing Authorization Holders (MAHs) operating in Morocco. ADRs can be reported via the national yellow notification form, available in both paper and online formats.
Critical PV Services for Moroccan Compliance
Navigating the Moroccan system requires both global expertise (E2B reporting, MedDRA coding) and crucial local execution. DDReg provides a comprehensive safety portfolio tailored to these requirements:
1. Individual Case Safety Report (ICSR) Management
Ensuring accurate and timely reporting is the cornerstone of PV. Our services include:
-
Triage and Case Processing: Handling initial and follow-up ICSRs, including SUSARs, using E2B(R3) compliant databases integrated with the WHO Drug Dictionary and MedDRA.
-
Submission & Reconciliation: Submitting cases strictly according to agency timelines and performing a monthly reconciliation process to ensure all cases are accounted for.
2. Local Pharmacovigilance Oversight
We provide the essential local infrastructure required by Moroccan regulations:
-
PV Quality Management System Oversight: Establishing and maintaining the local PV Quality Management System (QMS).
-
Documentation: Authoring, reviewing, and maintaining the Pharmacovigilance System Master File (PSMF) and local PV Standard Operating Procedures (SOPs).
-
Compliance Monitoring: Providing monthly communication reports and compliance metrics, and conducting regular Signal Surveillance Meetings (Quarterly).
3. Aggregate Reports and Risk Management
Regulatory authorities require a holistic view of the product’s risk profile:
-
Aggregate Report Writing: Preparing and submitting required reports such as Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Annual Safety Reports (ASRs).
-
Risk Management Plan (RMP): Drafting, reviewing, and maintaining the Risk Management Plan (RMP) in alignment with local requirements. This includes classifying safety risks, implementing additional risk minimization measures (e.g., educational materials), and conveying risks through product labeling (SmPC and PIL).
4. Signal Detection & Management
We proactively manage product safety by:
-
Signal Identification: Systematically monitoring the ICSR database, medical literature, and regulatory agency websites to identify new safety signals or changes in known risks.
-
Assessment and Recommendations: Providing expert recommendations from signal assessments, including suggested risk minimization approaches.
Partner with DDReg for PV Success in Morocco
Regulatory compliance in Morocco is complex and requires specialized knowledge. By partnering with DDReg Pharma, you gain access to a trusted global partner with the local expertise necessary to manage your drug safety obligations, ensuring patient safety and uninterrupted market access.
Ready to strengthen your PV compliance in Morocco?
Connect with Our Experts to discuss a customized pharmacovigilance solution.
