Evaluation of the Performance of the Iraqi Regulatory Authority: Recommendations to Optimize Patients’ Access to Medicines

Abstract

The Iraqi Regulatory Authority (IRA) has been a key player in the pharmaceutical industry, focusing on improving patients' access to medicines. The agency's organizational structure includes accreditation of manufacturing facilities for Good Manufacturing Practices (GMP), advertising regulation, laboratory examination of sample data, price control, marketing authorizations, and product licenses. The registration process involves a hybrid review procedure that uses type 1 and type 2 requirements and verification methods. The study has shown an urgent need to develop a unified national guideline to regulate all pharmaceutical product registration and marketing authorization in Iraq. Using identical analyzing and verification approaches when assessing new pharmaceutical products, especially in veterinary versus human products. Separating the regulatory body from the executive body to eliminate the main source of bias in the decision-making process. Creating a specialized auditing body to review the implementation of SOPs and to develop the gaps in guideline creation and evolution. Endorsing a continuous learning system where new staff regularly receive sufficient information on requirements and duties of each function, thus creating a sustainable environment within the regulatory body. Harmonize the process by aligning our operations with leading global agencies (stringent health authorities) to enhance workflow and optimize patients’ access to care.