In search of harmonized testing, regulations and manufacturing

Regulatory authorities and biopharmaceutical companies are engaged in a series of collaborations to harmonize research methods, approval standards and quality production methods essential to expanding global drug production. Although some initiatives predate the COVID-19 pandemic, the current health emergency has heightened the importance of collaborative efforts to accelerate biomedical research efforts and ensure broad access to quality medicines and vaccines.

An important message from COVID is the critical need for global regulatory convergence, commented Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), at the joint PDA-FDA regulatory conference last month. . He cautioned, however, that the movement towards greater information sharing seen in recent years is “going away” as the pandemic recedes, stressing the importance of joint efforts to provide pharmacovigilance information and review outcomes.

Such initiatives are not new to the FDA, which has worked for decades to provide technical assistance to regulatory authorities in low- and middle-income countries to advance regulatory convergence and improve drug production methods. The Promoting Quality of Medicines Plus (PQM+) program implemented by the United States Pharmacopeia, with support from the United States Agency for International Development (USAID), aims to build national regulatory capacity to ensure widespread production of high-quality treatments for neglected tropical diseases. , tuberculosis and other infections. A recent FDA webinar explained these issues to global regulators in low-income regions, with agency experts outlining FDA’s submission and regulatory processes and collaborative efforts to advance drug testing. drug quality.

Pharmaceutical manufacturers in Europe and other industrialized countries are similarly striving to ensure equitable access to vaccines and treatments in future pandemics, a framework designed by the International Federation of Manufacturers and Pharmaceutical Associations (IFPMA) to improve responses to future health emergencies. A statement released in July calls for the evaluation and identification of successes in pathogen surveillance and vaccine development and distribution during the pandemic. The organization is calling on biopharmaceutical companies to help regulators build pandemic preparedness and response capacity to accelerate the delivery of vaccines, drugs and diagnostics to their regions.

Similarly, the International Coalition of Medicines Regulatory Authorities (ICMRA) aims to harmonize standards for collecting real-world evidence, evaluating manufacturing information, and performing inspections in support of quality assessments. . A program encourages the collaborative evaluation of chemistry, manufacturing and control (CMC) data.

The FDA also supports global testing and review efforts, such as its Oncology Center of Excellence (OCE) Project Orbis, which was launched in 2019 to advance cancer drug development and regulation. Sponsors simultaneously submit applications for high-impact oncology products to participating regulators in Australia, Canada, Singapore, Switzerland, Brazil, the UK and the US to work together on new drug reviews against cancer and supplements for additional indications. While the OCE coordinates the program, each regulator makes independent regulatory decisions.

Privacy Barriers

One obstacle to global harmonization of biomedical regulation, however, stems from an EU effort to overhaul and strengthen its data privacy framework, despite the possibility of blocking regulatory access to necessary clinical trial information. and adverse event reports. The EU’s General Data Protection Regulation (GDPR), adopted in 2018, aims to limit the disclosure of individual information related to a range of personal activities, including healthcare. Unfortunately, these policies have created difficulties for FDA’s Biological Research Oversight Program (BIMO) inspections and for sponsors who submit patient information in new drug applications and other documents.

A report from the FDA’s European office, published in August, outlines how the GDPR prevents FDA BIMO investigators from reviewing and copying clinical health data involving EU citizens participating in multinational clinical trials and to review certain demographic and other information normally included in applications sent to the agency. . While the EU data framework aims to protect private information about a range of activities, the resulting limits on the FDA’s ability to assess EU health information pose challenges for progress. a global clinical research framework and common regulatory policies.