Euro Roundup: EMA answers IRIS questions as variation and notification notices move to new portal

The European Medicines Agency (EMA) has answered frequently asked questions (FAQ) about managing regulatory product lifecycle procedures to inform the switch to the IRIS submission system.

EMA began using IRIS for certain product variations, notifications and applications to transfer marketing authorizations for human and veterinary medicinal products on 23 January. The agency is decommissioning its current submission management system, SIAMED, and making IRIS the portal for communication between EMA, the EU network and applicants.

The FAQ, which the agency published on 19 January, covers questions about the transition to IRIS, its relationship to other EMA portals and more. EMA explains that “communication will continue at the same milestones during a procedure, linguistic review process” and that there are no plans to extend the use of IRIS to nationally authorized products. Similarly, mutual recognition and decentralized procedures will, with some exceptions, continue to be processed through systems other than IRIS.

It became mandatory for the marketing authorization holders for products selected for the first roll-out to use IRIS for the applicable procedures on 23 January. EMA will transfer the remaining centrally authorized products to IRIS once all procedures have been transitioned, “enabling a comprehensive lifecycle management even for the most intricate products.” EMA’s goal “is to effectuate a transition that is expeditious while maintaining compliance with regulatory standards.”

Validation issues may be handled within IRIS but, depending on the nature of the problem, EMA may use other channels, such as requiring the applicant to submit an updated electronic common technical document via Gateway. As EMA explains elsewhere in the document, IRIS and Gateway will coexist, with “each serving specific functions.” Equally, IRIS is not replacing the product lifecycle management portal, which EMA will continue to use for data submissions.

“The separate portals serve different purposes and have distinct protocols. We are actively working to enhance the user experience and streamline interactions between them to prevent duplication of processes and data input,” the agency wrote.

The FAQ also addresses practical points about using the new portal, explaining how notifications are handled, the process for submitting documents and the need to designate one person as the contact point for filings. EMA also clarifies that “IRIS follows the same data privacy and security protocols as the EMA Account Management System.”

EMA FAQ

European Council clears EMA to overhaul its fee system to ensure adequate funding

The European Council has adopted a regulation to modernize and simplify the structure of EMA fees, putting in place rules that policymakers believe will ensure there is adequate funding for the agency and sufficient support for national competent authorities.

Through the regulation, which will take effect at the start of next year, the European Union has set in motion the transition from a flat-rate to a cost-based fee system. The goal is to make the system “more flexible and adaptable to future needs,” including by adding provisions on updating or adapting fees to changing circumstances, and to simplify the existing legislation.

The European Commission proposed the regulation in December 2022, and the Council and Parliament reached an agreement on the final text weeks after starting negotiations in September 2023. Once the regulation takes effect in January 2025, the EU will repeal its two existing regulations on EMA fees.

Pharma trade group EFPIA welcomed the adoption of the regulation, stating that it will “support and ensure the modernization and sustainability of the regulatory system, allowing adaptability for emerging technologies that will address the future needs of healthcare systems across Europe.” EFPIA “supports a balance of simplification in fees administration while maintaining a proportionate cost-based approach.”

However, the trade group sees the regulation as part of a broader set of actions that are needed. EFPIA believes it is “essential that the EU regulatory system expands its capacities and capabilities by recruiting technical expertise in cutting edge fields and retaining experienced talent.” That applies to both EMA and national agencies, which it said need “appropriate funding, infrastructure and staff.”

“In some member states, the current lack of resources puts unprecedented pressure on national and EU regulators, and in turn undermines national, local and European competitiveness – crucial enablers of innovation,” EFPIA wrote. The trade group also used its statement about the fee rules to reiterate its call for changes to the planned pharmaceutical legislation.

Press Release, EFPIA Statement

First court judgment on SPC manufacturing waiver alarms off-patent drugmakers

Generic drug trade group Medicines for Europe is “strongly concerned” by a German court’s judgment on the supplementary protection certificate (SPC) manufacturing waiver.

The EU enacted the SPC manufacturing waiver in 2019 to enable companies to make medicines, under certain conditions, during the five-year extension of market protection awarded to patented medicinal products. Officials pitched the waivers as a way to preserve the competitiveness of the European generic and biosimilar medicines industry and stimulate investments in medicines manufacturing in the region.

A court in Munich, Germany issued a judgment on SPC manufacturing waivers in October. According to Medicines for Europe, the court “adopted an inordinately restrictive interpretation of the SPC manufacturing waiver, which cannot be derived from the letter of the law, and which contradicts the purpose and spirit behind the amendments that were introduced during its prosecution until its final approval.”

The trade group believes the judgment “utterly frustrates the aims of the legislation and disincentivises investments in Europe” because it “purports that SPC manufacturing waiver for export would require notification of a marketing authorization number ... or the disclosure of confidential information about future country of submission.”

“Although it is a first-instance judgment in an expedited procedure, issued in a single — but, for the pharmaceutical industry, significant — EU country, it will certainly be used by SPC holders to further threaten existing and future users of the SPC manufacturing waiver with lawsuits, or to sue them,” the trade group wrote.

Medicines for Europe is now pushing for the urgent simplification and clarification of the manufacturing waiver legislation because the current text is “drafted in a way that allows SPC holders to misinterpret the language before courts to the detriment of EU-based producers, and to the benefit of producers established out of Europe.”

Press Release

EDQM creates guide to policy on confidentiality and declassification of CEP documents

The European Directorate for the Quality of Medicines and HealthCare (EDQM) has published a guide to the declassification of documents related to the Certification of Suitability (CEP) procedure.

EDQM has created the guide to set out its principles for declassifying CEP documents while ensuring the confidentiality of information, when necessary. The text applies to “all documents received or distributed by the EDQM in the frame of the CEP procedure, covering its evaluation and inspection activities” and details the policy for declassifying files to make them accessible to the public.

The directorate said it is “committed to finding the best possible balance between transparency and confidentiality and aims to ensure that its processes and decisions are transparent” but is constrained by the need to protect the contents of documents that contain commercial confidential information and the assessors and inspectors involved in the CEP process.

Documents of a “non-public nature” such as CEP applications, assessment reports and data related to manufacturing inspections will not be declassified.

EDQM Notice

Euro Roundup: EMA answers IRIS questions as variation and notification notices move to new portal

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