European Commission finalizes plan to streamline variation process
The European Commission has finalized plans to improve lifecycle management of medicines through changes to the regulations on marketing authorization variations.European Union lawmakers last made major changes to the Variations Regulation framework in 2012. As the Commission explained in a staff working document, the number of overall variations has increased since then, “Draining the resources of regulatory authorities and industry alike.” The rise in workload has coincided with advances that show “there is room for improvement in terms of efficiency, flexibility and continuous adaptation to change,” the Commission wrote.
That thinking led the Commission to put out a call for evidence in August 2023. After gathering feedback, officials created a draft delegated act and shared it for consultation in February. The delegated regulation, which the Commission published Monday, is almost identical to the earlier draft.
In the final document, the Commission proposes removing the default type II classification for quality and manufacturing changes for biological products, including advanced therapies. The change reflects a belief that “increased knowledge and experience” of the class of medicines supports the extension of the risk-based approach to variation categorization.
The Commission estimates up to 20% of type II variations could be reclassified as type IB variations as a result of the move to a risk-based model. Because type IB variations can have a 30-day procedure with shorter evaluation times, the shift could achieve efficiency gains for manufacturers and regulators.
Industry representatives welcomed the change. In feedback submitted on the draft, pharma trade group EFPIA listed the revision to the rules on biological products as one of the changes it was “encouraged to see.”
EFPIA also welcomed the extension of vaccine rules. The Commission wants to apply the rules and procedures for human influenza and coronavirus vaccines to all vaccines addressing a public health emergency. Regulators will treat any changes as “a type II variation and not as an extension or a new marketing authorization application” to streamline the variation process, the Commission said.
Officials are also planning to make it mandatory to submit an annual update for minor type IA variations to reduce the number of individual submissions. Companies will make annual submissions electronically through systems that can be linked to centralized or national databases, thereby ensuring files stay up-to-date.
The Commission estimates that each type IA variation that is added to an annual report, rather than sent separately, will save 60 minutes of administrative time. If 10,000 type IA variations are sent in batches of 10 per annual report, the Commission calculates the change could save the European Union 266,000 euros ($291,000) a year.
EFPIA included the “reference to annual updates for minor variations” on the list of changes it is pleased to see. The trade group also singled out plans to retain “the flexibility of immediate submission in some cases” as critical to the proposal.
In contrast, off-patent drug trade group Medicines for Europe listed the annual report plan among its “issues with the proposal not leading to optimization,” specifically because of uncertainty about when companies can submit standalone type IA variations. The trade group warned “possible exemptions are very unclear and will trigger a lot of unnecessary interactions” on whether to grant exemptions.
Other planned changes include the extension of the scope of the super-grouping procedure. Officials plan to include national marketing authorization holders alongside those that followed the decentralized or mutual recognition routes, eliminating the need for parallel submissions of identical variations and thereby reducing the administrative burden.
Currently, up to 30 applications can be needed, one grouping for mutual recognition procedures and decentralized procedures plus 29 national applications. Under the new system, applicants would send one super-grouping submission for all member states. Officials have also proposed extending the use of super-groupings to quality changes. Only administrative changes are allowed today.
The Commission set out the changes in a delegated act. Typically, the European Parliament and Council have two months to raise any objections to delegated acts. If no objections are heard, the delegated act comes into force.
Press release
Delegated regulation
×
Welcome to the new RAPS Digital Experience
We have completed our migration to a new platform and are pleased to introduce the updated site.
What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.
We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.
We welcome your feedback. Please let us know how we can continue to improve your experience.