he ICH E5 guideline “Ethnic factors in the acceptability of foreign clinical data” and E17 guideline “General principles for planning and design of multi-regional clinical trials” present harmonized methodologies to efficiently develop drugs in multiple regions while considering ethnic differences in drug responses.

OVID-19 has ushered in a new age of urgency for pharmaceutical companies, one that simultaneously requires increased regulatory flexibility and unwavering commitment to quality. Now more than ever, companies recognize the importance of ensuring quality at each of their units and sites around the world. To achieve oversight of their quality outputs across the globe under these challenging circumstances, organizations must globalize the quality function rapidly but also thoughtfully.

atients have been asking to be heard and engaged for decades. More recently, their call has been echoed by academics and providers. Today, Patient Engagement in the development, launch, and use of medicines has become an accepted necessity. Indeed, the historical risk of engaging patients has been surpassed by the future risk of not engaging patients.

he development of chimeric antigen receptor (CAR) T therapy for patients with advanced hematological malignancies represents one of the greatest successes in bringing basic tumor immunology to the bedside. The ability to potentially cure patients with end-stage acute lymphocytic leukemia (ALL) and diffuse large B-cell non-Hodgkin lymphoma (DLBCL) with a personalized immunotherapy seems science fiction. And yet the rate of uptake of this therapy has been slow, particularly in US Medicare beneficiaries.

We have identified three major areas that should be addressed:

1. Measuring what matters: recognizing real world value.
2. Patient flow and practice management: enhancing the patient experience.
3. Payment policies for cell therapies: acknowledging and fixing Medicare’s shortcomings.

lectronic labeling is the focus of many ongoing initiatives across regions. eLabeling can deliver the latest labeling information immediately and in an efficient and customer-friendly way for patient safety. Also, eLabeling is driven by the acceleration of digital disruption and must consider patient-centricity.

DIA’s recent Global Labeling Conference 2020 opened with industry and regulatory experts discussing the current landscape of electronic labeling initiatives in Japan, Canada, Europe, Belgium and Luxembourg, US, and Asia.

Key Takeaways

• Japan’s Pharmaceuticals and Medical Devices Act was amended to introduce eLabeling officially, replacing paper labeling and adding a necessary scheme that allows all healthcare professional access the up-to-date labeling information.
• Health Canada is taking steps to transition the product monograph to a new structured format based on Extensible Markup Language (XML), Health Level 7 (HL7) standards, and controlled vocabularies.
• Together with other relevant stakeholders, European regulators have established high level key principles that will guide future work in establishing, for example, common electronic standards, processes, and governance that all need to benefit public health.
• The US Food and Drug Administration (FDA) has long sought to leverage digital platforms for prescription drug labeling intended for physicians and pharmacists, allowing for distribution of prescribing information in a timely manner.

OVID-19 has brought us all into unchartered waters. Many African countries, following the advice of the World Health Organization (WHO), have implemented detection and control measures including the lockdowns of entire countries. According to the WHO and other public health experts, health systems in Africa are predicted to become overwhelmed by the COVID-19 burden if aggressive measures to prevent the spread of coronavirus are not implemented. As of May 31, 2020, the cumulative COVID-19 cases in Africa were over 100,000 (Source: WHO Coronavirus disease (COVID-2019) situation reports).

n June 2, the European Commission (EC) published a Roadmap detailing the future Pharmaceutical Strategy with the telling subtitle Timely patient access to affordable medicines. The pharmaceutical sector is important to the EU economy, and in 2018 it offered approximately 850,000 jobs in the sector and created a €91 billion trade surplus. To this end, the Roadmap is important to the European Union (EU) pharmaceutical industry as it aims to ensure that the sector remains a competitive innovator and world leader in advancing regulatory science for the benefit of patients worldwide.

The first reported case of COVID-19 in Japan was confirmed on January 16, 2020. The number of cases increased steadily thereafter and by mid-March more than 1,000 cases had been reported. In early April, the infection rate began to increase rapidly with several hundred new cases confirmed daily. By April 17, more than 10,000 cases had been reported.

Key Takeaways:

• Different interpretations of risk caused by COVID-19 among sponsors have resulted in inconsistency in decisions to continue or suspend clinical trials in Japan.
• Source data verification and monitoring are among the aspects of clinical trials most negatively impacted by COVID-19, but some of these impacts have been and may continue to be ameliorated by the growing application of remote and digital tools.
• This pandemic has also highlighted the importance of crisis management strategies and skills that require further examination and improvement to ensure a better response to future crises.

ntroduction: In the past twenty years, the Brazilian regulator ANVISA has been increasingly working to improve regulatory processes and gain credibility in the field of health regulation. The Agency’s current position as a regional and global leader is the result of different efforts, and this article brings information about one of them – its adoption of Good Regulatory Practices.

The normative acts referred to below are any decisions enacted by ANVISA establishing norms, rules, standards or obligations. These include, among others, Resolutions, Norms, Normative Instructions, or Joint Acts with other government bodies.

The Brazilian Health Regulatory Agency (ANVISA) is an autonomous organization linked to the Ministry of Health and is part of the National Health System (SUS) as coordinator of the Brazilian Health Regulatory System (SNVS). ANVISA’s role is to promote the protection of the population’s health by controlling the production, marketing, and use of products and services subject to health regulation.