Quality & Compliance
Safety & Vigilance
09 october 2023
In a significant stride towards modernizing regulatory processes, the European Medicines Agency (EMA) recently unveiled a major update regarding web-based Electronic Application Forms (eAFs). This pivotal development aims to enhance efficiency, transparency, and user experience within the regulatory landscape. The Product Lifecycle Management (PLM) Portal is central to this initiative, which serves as the cornerstone for these transformative changes.
The eAF and Product Management Service (PMS) teams are diligently working on implementing web-based Human Variations eAF on the PLM Portal. By the first quarter of 2024, several key milestones will be achieved:
To ensure a smooth transition towards the mandatory use of web-based Human Variations eAFs, the EMA has outlined vital steps:
The transition to web-based eAFs holds profound implications for stakeholders in the pharmaceutical and regulatory sectors. Applicants and regulators alike can anticipate several benefits:
The EMA has organized a joint eAF-PMS webinar on Nov 6th, 2023, to keep stakeholders informed and engaged. During this session, attendees will be able to explore the implementation progress and challenges faced and witness demonstrations of anticipated features like “add package” and “clone application.” Additionally, stakeholders are encouraged to review the Q3 System Demo recording available on EMA’s website for a deeper understanding of the ongoing developments.
Considering these changes, it is reassuring to note that PLG, a dedicated service provider, stands ready to assist stakeholders in navigating these transitions. Their expertise ensures applicants and regulators can seamlessly adapt to the updated processes.
As the EMA continues its journey towards a digital future, these updates mark a significant milestone, ushering in an era of streamlined processes and heightened efficiency in the regulatory landscape. With transparency, user experience, and data integrity at its core, the EMA’s web-based eAF initiative is poised to revolutionize how stakeholders interact with regulatory frameworks, ensuring a brighter and more accessible future for all involved parties.
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