The European Medicines Agency (EMA) has released the updated "IRIS Guide for Applicants," which provides detailed instructions on how to create, submit, and manage applications using the IRIS platform. This guide is essential for pharmaceutical companies, regulatory professionals, and individual applicants handling scientific applications related to orphan designation, scientific advice, inspections, and other regulatory procedures.
The IRIS platform is an online submission system used by the EMA to handle various regulatory procedures, including:
Orphan drug designation
Scientific advice applications
Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) inspections
Marketing status updates
Parallel distribution notifications
Product lifecycle management (PLM) submissions
IRIS is designed to improve transparency, efficiency, and communication between the EMA and applicants.
Orphan Drug Designation Submissions in IRIS: For orphan drug designation, applicants must first submit a pre-application request to assess their eligibility. This is followed by a formal application where detailed prevalence data, medical justification, and evidence of significant benefit over existing treatments must be provided. Once the designation is granted, sponsors are required to submit annual reports on the development progress of the orphan drug. If there are changes in ownership or sponsor details, post-designation modifications must be made through IRIS. The platform ensures continuous monitoring and compliance with orphan drug regulations.
Scientific Advice and Regulatory Support: Scientific advice submissions through IRIS allow companies to receive guidance from EMA experts on clinical trial designs, research methodologies, and regulatory strategies. This advice helps applicants align their drug development plans with EMA approval standards, reducing the risk of regulatory rejection. The system enables users to submit requests for protocol assistance, especially for orphan drugs, and seek qualification of innovative methodologies such as biomarker validation.
Marketing Status Updates and Inspections: Marketing authorization holders are required to report any changes in the market availability of their products through IRIS. This includes product launches, withdrawals, and temporary market cessations. The system also supports bulk updates for multiple product presentations across different EU markets. If a medicinal product is being permanently withdrawn, applicants must provide a justification and compliance statement, ensuring adherence to EU regulatory requirements.
Compliance inspections: Companies can request inspections to verify that their manufacturing facilities, clinical trial sites, and pharmacovigilance systems meet EMA standards. If deficiencies are found, applicants can submit corrective action plans through the platform to address regulatory concerns.
Parallel Distribution and Product Lifecycle Management (PLM) Submissions
The IRIS system allows applicants to submit parallel distribution notifications for centrally authorized medicines. Companies involved in parallel distribution must update their submissions annually and provide details of batch tracking, repackaging operations, and manufacturing changes.
For product lifecycle management (PLM): IRIS facilitates applications for post-authorization changes, such as variations, renewals, and safety updates. Pharmaceutical companies can manage their regulatory obligations efficiently, ensuring compliance with ongoing pharmacovigilance requirements.
Paediatric Investigation Plans (PIPs) and Compliance Monitoring: Pharmaceutical companies developing medicines for children must submit Paediatric Investigation Plans (PIPs) through IRIS. This ensures that medicines intended for paediatric use undergo proper clinical evaluations before market authorization. The system allows applicants to submit initial PIP applications, request modifications, and provide compliance reports to verify adherence to paediatric study obligations.
The EMA IRIS platform plays a crucial role in regulatory submissions, scientific advice, and compliance monitoring. By using IRIS, pharmaceutical companies and regulatory professionals can streamline their submissions, enhance transparency, and improve communication with EMA.
🔗 For full details, visit:IRIS Guide for Applicants (EMA)
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