An Insightful Conversation with Dr. Esraa A. Zoubi, General Manager Advisor for Regulatory and Pricing Affairs at the Jordan Food and Drug Administration
Jordan FDA is the first Arabic regulatory authority, that has well-established regulations that govern drug efficacy and safety. In an exclusive interview with Dr. Esraa A. Zoubi, General Manager Advisor for Regulatory and Pricing Affairs at the Jordan Food and Drug Administration (JFDA), we gained valuable insights into the rigorous regulatory oversight and measures implemented to ensure the safety of pharmaceuticals in the Jordanian market. Dr. Zoubi shed light on the collaborative efforts between the JFDA and industry stakeholders to maintain high drug safety standards.
Regulatory Oversight and Safety Measures
“At JFDA, we prioritize pharmaceutical safety
through strict adherence to laws and guidelines. Our comprehensive approach includes thorough registration, evaluation of eCTD modules, and stringent inspections, reflecting our unwavering commitment.”
– Dr. Esraa A. Zoubi
When asked to elaborate on the regulatory oversight and measures taken by the JFDA, Dr. Zoubi emphasized that the JFDA strictly adheres to laws, guidelines, and instructions to ensure the safety of pharmaceuticals in the market. She highlighted several key steps taken by the JFDA in this regard:
Registration and Analysis: The JFDA mandates that all pharmaceuticals in the Jordanian market undergo a rigorous registration process, ensuring transparency and accountability. Additionally, a comprehensive analysis of each medicine is conducted to verify its safety and efficacy.
Evaluation of Modules in eCTD: The electronic Common Technical Document (eCTD) serves as a crucial repository of information for pharmaceutical products. The JFDA meticulously evaluates all modules within the eCTD, emphasizing a thorough examination of documentation related to drug registration.
Clinical and BE Studies: Dr. Zoubi underscores the critical role of clinical and bioequivalence studies in the evaluation process. These studies serve as essential benchmarks, providing insights into the safety and effectiveness of pharmaceutical products, and contributing to informed regulatory decisions.
Manufacturing Site Inspection: To guarantee adherence to quality standards, manufacturing sites undergo stringent inspections by the JFDA. Accreditation is exclusively granted to facilities that comply with the Jordan Good Manufacturing Practice (GMP) guidelines, ensuring the production of safe and high-quality pharmaceuticals.
Approval of PAC: Post-approval changes (PAC) demand careful consideration by the JFDA before implementation. This regulatory step reinforces ongoing oversight, ensuring that any modifications to registered medicines meet established safety and efficacy standards, safeguarding public health.
Post-Marketing Surveillance
“In our post-marketing surveillance, JFDA’s robust pharmacovigilance system ensures safety. Adhering to Jordan PV regulations, employing diverse reporting platforms, and establishing national PV centers exemplify our proactive approach to pharmaceutical safety.”
– Dr. Esraa A. Zoubi
Dr. Zoubi detailed the JFDA’s post-marketing surveillance system, which includes a robust pharmacovigilance (PV) system. This system monitors safety by reporting adverse drug reactions (ADRs) and evaluating periodic safety update reports (PSURs) and risk management plans (RMPs).
Adherence to Jordan PV Regulation: The JFDA is committed to maintaining a vigilant approach to pharmacovigilance (PV) by strictly adhering to Jordanian pharmacovigilance regulations. This commitment ensures a systematic tracking and response mechanism for potential safety issues linked to pharmaceutical products.
Reporting Platforms: Dr. Zoubi highlights the diverse and accessible reporting platforms utilized by the JFDA. These platforms, ranging from electronic systems to traditional paper submissions, emails, and telephone channels, provide a flexible and comprehensive means for reporting adverse drug reactions (ADRs). This approach aims to encourage prompt reporting and capture information through various communication channels.
Obligation of MAHs: Marketing Authorization Holders (MAHs) play a pivotal role in the pharmacovigilance process. The JFDA places a clear obligation on MAHs to promptly report any adverse drug reactions they become aware of. This collaborative responsibility ensures a proactive approach to monitoring and addressing safety concerns associated with pharmaceutical products.
National PV Centers: Recognizing the importance of localized response capabilities, the JFDA has strategically established national pharmacovigilance (PV) centers across Jordan. These centers serve as key hubs for monitoring, analysis, and response, strengthening the overall surveillance system. By decentralizing these efforts, the JFDA ensures a swift and efficient response to emerging safety issues in different regions of the country.
Regulatory Challenges and Technological Solutions
Dr. Zoubi acknowledged the regulatory challenges faced by the JFDA, particularly in the
implementation of PV regulations by MAHs and the need for training and capacity building within the pharmaceutical industry in Jordan. She emphasized the importance of leveraging innovation and technology to overcome these challenges and enhance regulatory processes. In conclusion, Dr. Esraa A. Zoubi provided a comprehensive overview of the regulatory landscape in Jordan, emphasizing the JFDA's commitment to ensuring the safety of pharmaceuticals through rigorous oversight, collaboration with industry stakeholders, and the adoption of innovative solutions to address challenges in drug safety regulation.
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Dr. Esraa A. Zoubi will be presenting the Role of JFDA in Patient Safety at the Drug Safety
Symposium 2024 on 14-15 February 2024 at Holiday Inn & Suites, Dubai.
To Register Contact – Abhay@eminencemedia.in
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