n today’s increasingly complex and intricate pharmaceutical landscape, industry and regulators alike frequently state the same core aim: to ensure that pharmaceutical products offer significant benefit to patients. This concept is captured via varied phrasing including reference to the voice of the patient, benefit/risk analysis, confidence in the next dose, and patient centricity, among many others. However, in all cases, fundamental benefit to patients is essential and is broken down into three pillars: efficacy, safety, and quality. Accordingly, in the pharmaceutical quality landscape, it is critical to develop common ground among regulators and industry when discussing patient centricity.

atient authorship of peer-reviewed publications is increasing, with patients not only presenting their own or academic research, but also participating as co-authors of pharmaceutical company-sponsored research. In this two-part series we:

• highlight the drivers and value of involving patients as authors from both the patient and industry perspectives (Part A), and
• discuss how journals are evolving to facilitate inclusion of the patient voice in peer-reviewed publications and extend the reach of publications to lay audiences (Part B).

atients are becoming increasingly involved in medical publications. This includes taking an active role in the publication process, as well as reading peer-reviewed journals that have traditionally considered their audience to be healthcare specialists. As academic publishers have traditionally worked with researchers and professionals across academia and industry, they are less familiar with working with patient communities or members of the public. This has led to a need to develop new ways of working that are appropriate both for the publishers, and for the patients and patient representatives with whom they are engaging.

harmaceutical labeling is continuously in the spotlight, due to FDA regularly issuing new guidelines, including these in May 2022, to which manufacturers must adhere. Historically, the management and tracking of labeling required a “mishmash” of different solutions for various aspects of the labeling operation, including programs like Microsoft Project for planning and monitoring. The regulatory agency also requires drug companies to create a risk minimization plan, particularly for sensitive medications such as those that can affect pregnancy.

n Association executive, two regulators, two professors, a patient advocate, a patient, and a graphic artist walked into a packed congress hall. Inspiration ensued.

n July 16, 2022, the Executive Council of the African Union (AU) announced that Rwanda had been selected to host the first headquarters of the African Medicines Agency (AMA).

The AU approved the treaty for establishing the AMA in February 2019 after five years of consultations across the African continent led by a task force established by the World Health Organization (WHO) and AU Commission. The Agency was formally established after the minimum number of 15 ratifications by AU countries was reached in November 2021. In fact, as of May 2022, 31 of the 55 nations in the AU have signed/ratified the treaty (19 ratified and deposited + 3 ratified but not yet deposited + 9 signed but not ratified).