Regulatory geostrategy supporting optimized patient access

Written by: Fleming. Team

Philippe Motté

Vice President Regulatory Affairs International

What are the main differences between an exclusively EU regulatory strategy and one that must adapt to other regulatory environments?

Designing a worldwide regulatory strategy means finding the best compromise between reaching a target profile, mitigating regulatory risks and investing in a global development plan. ICH requirements define the level of expectations for regulatory approval in the major geographies of the US, the EU and Japan. However, depending on the drug and disease, there may be additional expectations to be defined by the three major agencies, for both regulatory approval as well as to support market access. Additionally, other regions of the world may have specific CMC and/or clinical requirements for registration and market access. Companies need to anticipate those requirements early in the development program in order to design the most appropriate dossier content for all regions, and maintain an open dialogue with agencies to get input on development programs early, and to ensure any differences from guidance documents or previous advice is justified and supported by robust data.

From your point of view, is regulatory intelligence needed? What are its main benefits?

Regulatory intelligence is key in understanding regulatory requirements and regulatory opportunity. This can be achieved through participation in industry association workshops and direct contact with regulatory agencies, for example, during scientific advice and also by monitoring the decisions of the agencies regarding other drugs. Understanding the expectations and landscape will help mitigate risks in a development plan and quantify the probability of registration success.

What are AbbVie's best practices to adhere to the highest quality and regulatory standards?

AbbVie has designed a “Quality Dossier Program” that allows all functions to align on the expectations for quality dossier content and timelines. This is based on collecting information from all over the world on dossier requirements and reviewing this information regularly for updates.

What are the biggest challenges for Pharma and Biotech in the current regulatory field?

Many challenges are in front of us. I believe that two of the most crucial ones will be to progress in expedited pathways of registration, and defining the most appropriate way to have “real-world data” taken into account in the registration dossier to support initial approvals as well as new indications or line extensions. The involvement of patient representatives in development programs, and the subsequent regulatory review, is another important opportunity and challenge.
I would also consider that progressing towards increased alignment of regulatory agencies in their requirements is a desired outcome of the next years.

Philippe Motté will be speaking on the topic of Regulatory geostrategy supporting optimized patient access at Global Regulatory and Submissions Management in the Pharmaceutical Industry. To know more about the conference, download the agenda below.

Europe Pharma

Global Regulatory and Submissions Management in the Pharmaceutical Industry

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