Masterarbeit

Enhancing Regulatory Reliance practices in international cooperation: A Focus on Information Sharing

Guy Noel Mouoffo (2024)

Summary
Language: English
Before being marketed, medicinal products undergo a rigorous evaluation procedure by regulators. To manage the increasing review workload in an ever-globalising world and reduce duplication, RAs have established reliance initiatives. These initiatives, which can take the form of work-sharing, collaborative review, or even unilateral reliance, necessitate information sharing among regulators.
This study analyses the preconditions for information sharing and its impact on the approval/decision times of the ACCESS and Orbis project initiatives. The evaluation of these preconditions reveals that both initiatives have legal provisions in each member country defining the non-disclosure of confidential information and the exceptions for disclosure. Additionally, all regulators have developed collaborative tools such as confidentiality commitments, confidentiality agreements, and MOUs to facilitate information exchange. For both initiatives, it is specified at which application assessment milestones information will be exchanged, the type of information shared, the platform used (secured SharePoint), and the means of communication, such as teleconferences. The study clearly demonstrates that information-sharing mechanisms within regulatory reliance are governed by the following principles:

• Legal provisions and frameworks for withholding and disclosing commercially confidential information, which also imply trust.
• Secure IT tools for sharing documents and communication.
• Formal consent from applicants.

These principles are crucial; without them, information sharing within both ACCES and Orbis initiatives would have been challenging, as regulators would have risked breaching their national laws.
The approval/decision timelines for the 34 NAS and new indication applications submitted via the ACCESS procedure to two or more ACCESS regulators, as well as the approval gaps to the FDA for the 41 NAS and new indication applications submitted via Orbis to the FDA, Swissmedic, and/or MHRA, were analysed. These timelines were also compared to those of the EMA for products submitted there as well. The analysis demonstrates that both reliance pathways are competitive compared to standard procedures in terms of approval or decision times. The approval/decision time correlates with the level of information sharing, as Type A and B Orbis, which involve deeper information exchange among regulators, had shorter timelines compared to Type C Orbis, which involves less information sharing.
Although both ACCESS and Orbis are competitive, this study shows a clear trend of increasing approval or decision timelines over time. This trend is further emphasised by the analysis of approval gaps within each initiative. For instance, in ACCESS, out of the 34 completed applications, 16 (50% of all completed applications) experienced delays of more than 60 days between regulators in the decision-making process, with the highest gaps reaching 218 days. These increased approval gaps are related to further negotiations (such as labeling) and advisory committee meetings in the national phases following the completion of the collaborative review. This may imply that the collaborative assessment is not fully endorsed and leveraged by all participating regulators.
There is thus a need for continuous evaluation of both initiatives to keep them competitive over time and to further define the information to be shared and the points to be addressed and completed within the collaborative assessments. This also indicates a need for further harmonisation of procedures within both initiatives.
Pages: 63
Annexes: 3, Pages: 11