Philipp Pauli

Pharma companies globally are building the capabilities they’ll need to comply with widely varying national CMC regulatory requirements over the next decade. This was the main takeaway from BCG’s recent semiannual CMC Regulatory Roundtable.

The 12 companies that participated in the event held in early November outlined what kinds of capabilities they are building. There was general consensus that three areas of focus—implementing ICH quality guidelines, the authoring of regulatory dossiers, and the developing digital capabilities—would all be critical for meeting current requirements.

Implementing ICH Quality guidelines The harmonization of national requirements will undoubtedly be a long journey. Companies that develop one product still need to apply for more than 100 approvals worldwide. If they make a change to the dossier after the approval, they must classify the change as an annual report in one country, a notification in another, and a prior approval supplement (PAS) in yet another. Maximum review timelines are only established in a few countries—it can take up to three years for the same change to be approved everywhere.

Regulatory authorities and the pharmaceutical industry are collaborating to find ways to accelerate the harmonization process. Their joint initiative, the ICH, has published several guidelines that delivered step-change improvements, including the Common Technical Document (CTD), which divides dossiers into five standardized modules with defined subheadings by jurisdiction. Module 1 is specific to the particular region, while the other four are common to all regions (See Exhibit).

ICH’s newest guideline, Q12, aims to simplify post-approval lifecycle management. Yet although Q12 is a very important step towards harmonization, the implementation has progressed unevenly, with critics saying that it overlooks key areas such as change categories and approval timelines.

Our participants agreed that seamless collaboration between global, regional, and local regulatory functions will be critical. For example, a company’s global regulatory team should generate different versions of the dossier for each major region; the EU regional version would then typically serve as a basis for the rest of world, with only little further adoption required. Local regulatory would customize the versions sent by the global function, if required, and then submit the final dossier to the local authority.

Authoring Regulatory Dossiers Authoring regulatory dossiers in a consistent and compliant manner is a core capability of the CMC regulatory function, but it’s often the bottleneck in the submission process. That’s because the CTD breaks the dossier into numerous sub-sections that often don’t map to the way content expertise is distributed in many large pharmaceutical companies. Using a BCG benchmark for reference, we discussed best practices for dealing with this challenge.

A more streamlined operating model, whereby authoring responsibility is shared by technical lines (R&D and technical operations) and the regulatory department, is essential, especially for products in development. After regulatory approval, many companies move authoring responsibility to a single dedicated authoring group located in the CMC regulatory function. Since at this point the volume of work for the marketed portfolio is usually more predictable and authoring tasks are less complex, a single dedicated team is often more efficient.

Developing Digital Capabilities Acquiring digital capabilities in the CMC regulatory space has been a priority for several roundtable participants, who are sustaining their first use cases along the value chain. One participant said her company is implementing automated screening and management of regulatory requirements. This integrated tool helps prioritize, plan, and bundle submissions.

Several participants agreed that building digital capabilities should start with modernizing platforms for regulatory information management. Replacing legacy IT systems with an integrated platform enables easier design, scoping, piloting, and scaling up of digital use cases.

Scaling up—the most important step—is extremely challenging because it involves making changes in processes and ways of working that, for many companies, have been in place a long time. Complicating things further, health authorities, the regulatory function’s main external stakeholders, are not adopting digital as quickly or extensively as private companies.

Still, digital offers a lot of untapped potential for CMC regulatory, and so we expect significant changes over the next few years that will create value for the industry as a whole. COVID-19 has shown how important it can be to speed up the review process, which was achieved by implementing a rolling review of some vaccine applications. Imagine a world where pharma companies and regulatory authorities could seamlessly exchange documents in real time and where AI-enabled review of documents could help authorities make final decisions better and faster.

The conversation will be continued in focus discussions at BCG’s next Roundtable event, in the spring of 2021. If you’d like to participate, please reach out to me at pauli.philipp@bcg.com.

Philipp Pauli

Deutschland

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Takeda Oncology

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Deutschland 1550 Follower:innen 500+ Kontakte

Berufserfahrung

Takeda Oncology

Philipp Paulis vollständiges Profil ansehen

Weitere ähnliche Profile

Ralph Mair

Lennart Schlinkmann

Olivier Noth

Nicolai Kirstaetter

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Martin Prost

Ruben Oberholzer

Ursina Schärer

Tobias Sutter

Adrian Grunder

Michael Köhler

Stefan Scheidegger

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Leon Gaugler

Martin Schumacher

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Sebastian Spittler

Ole Buchholz

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