Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations.

The Access Consortium New Active Substance Work-Sharing Initiative, or "Access" for simplicity, allows regulatory authorities (RAs) of the Access Consortium countries to jointly review applications for the registration of new active substances or for new indications. Using a survey developed by the pharmaceutical industry trade associations of the five Access Consortium countries-Australia, Canada, Singapore, Switzerland, and the United Kingdom (UK)-this study gathered insights into the perceptions and experiences of the Access pathway held by affiliates of pharmaceutical companies. Understanding industry perceptions of Access is important for the success of the initiative, as participation is voluntary. Findings indicate that affiliates who participated in Access had mostly positive experiences with this pathway; most affiliates were satisfied with their interactions with the Access RAs and appeared willing to continue to participate in the initiative. Affiliates' reasons for not having yet participated in Access included a lack of opportunity to do so and perceived barriers, such as the Access pathway being too complicated to manage. Recommendations to improve Access cover six key areas: ensure predictability, increase guidance and transparency, streamline processes, maintain flexibility, increase harmonization, and advance RA-industry cooperation. This study should facilitate informed discussions among relevant stakeholders on how to improve Access to maximize efficiencies, accelerate approvals, and improve patient access to innovative medicines.

Medicinal Product Development and Regulatory Agilities Implemented During the Early Phases of the COVID-19 Pandemic: Experiences and Implications for the Future-An Industry View.

The COVID-19 pandemic caused considerable disruption to the development, regulatory evaluation, production, and distribution of medicinal products. Key healthcare stakeholders were under pressure to develop and review medicinal products to address the health emergency, while preserving the continuity of activities to ensure patient access to other medicinal products. In the light of this challenging situation, the National Regulatory Authorities (NRAs) and the biopharmaceutical industry applied and utilized product development and regulatory agilities to accelerate the development and authorization of safe, effective and quality COVID-19 vaccines and treatments as well as other non-COVID-19 medicinal products. On the basis of the literature review and primary research conducted, this review article gathered insights on experiences and challenges in the use of agilities related to regulatory assessment of initial marketing and post-approval change (PAC) applications, oversight of product manufacturing quality and supply chain continuity, and product development/clinical trial processes during the early phases of the COVID-19 pandemic. Agilities were thus implemented in an emergency context characterized by the lack of medicinal products to help tackle a disease that was devastating for the global public health. This review article concludes that useful lessons can be learned from these insights to improve product development practices and regulatory processes during both normal and health emergency times. Standard regulatory frameworks during normal times can be enhanced by leveraging digitalization, further simplifying and harmonizing requirements, and using reliance mechanisms which can help to increase efficiency in regulatory decision-making regarding medicinal products. During health emergencies, such as a pandemic, maximizing global coordination, collaboration, reliance, and harmonization of regulatory requirements and guidance are important to facilitate the rapid development and assessment of key medicinal products to address the health emergency.