DIA Europe: Variations regulation expected to ease postapproval changes for pharmaceuticals
BASEL, SWITZERLAND – The recent EU Variations Regulation that took effect in January is expected to simplify and future-proof the process for implementing manufacturing changes for medicinal products, according to Mónica Perea-Vélez, CMC advocacy and policy director at GSK, who spoke at DIA Europe 2025 on 19 March.Perea-Vélez, who spoke on behalf of the European Federation of Pharmaceutical Industries and Associations (EfPIA), provided an update on some of the legislative developments shaping the postapproval change climate in the EU.
Perea-Vélez emphasized that the new variations regulation represents a groundbreaking advancement that will enhance the lifecycle management of pharmaceutical products in the EU. Other promising developments include the forthcoming guidance for implementing the variations regulations, expected to be released in the second quarter of this year, as well as the increasing number of regulatory pilots exploring postapproval changes.
In June 2024, the European Commission published the final version of the regulation; the regulation provides a framework for implementing postapproval changes to medicinal products.
The new regulation requires a downgrade in the default classifications for type 2 biological products and establish a system for annual reporting of type IA variations. Instead of submitting separate annual updates for minor type IA variations, these updates can now be consolidated into a single annual report.
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. (RELATED: European Commission finalizes plan to streamline variation process, Regulatory Focus 13 March 2024)
Perea-Vélez said that “we are moving from a very old-fashioned regulatory framework” to one that is future-proofed.
The previous framework focused on simple products with minimal changes and relied on limited scientific and risk-based approaches. In contrast, the new framework acts as an "enabler for change and innovation." It adopts a science- and risk-based approach, offers advanced control strategies, and introduces new modalities and additional biologics.
Another positive development improving the post approval landscape is the growing number of postapproval change (PAC) pilots among regulators. These pilots cover prospective changes to be implemented, and protocols outline the necessary studies and acceptance criteria to support the changes.
Ten postapproval change pilots have been conducted by the World Health Organization (WHO) and the European Medicines Agency, while five pilots have been conducted by the International Coalition of Medicines Regulatory Authorities (ICMRA) to explore a common regulatory framework for assessing manufacturing facilities during hybrid inspections and reviewing postapproval changes. ICMRA announced the pilot in June 2022. (RELATED: ICMRA explores hybrid inspections, postapproval changes with new pilots, Regulatory Focus 29 June 2022).
