Seeking Harmonized Testing, Regulation, and Manufacturing

Regulatory authorities and biopharma companies are engaged in a range of collaborations to harmonize research methods, approval standards, and quality production methods key to expanding global drug production. While some initiatives predated the COVID-19 pandemic, the ongoing health emergency has elevated the importance of collaborative efforts to speed biomedical research efforts and to 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 & Research (CBER), at the PDA-FDA Joint Regulatory Conference last month. He warned, though, that the move toward greater information sharing seen in recent years is “slipping away” as the pandemic recedes, speaking to the importance of joint efforts to provide pharmacovigilance information and review findings.

Such initiatives are not new for 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 US Pharmacopeia, with support from the US Agency for International Development (USAID), aims to build in-country regulatory capacity to ensure broad production of high-quality treatments for neglected tropical diseases, tuberculosis, and other infections. A recent FDA online seminar explained these issues for global regulators from lower-income regions, with agency experts describing the FDA’s submission and regulatory processes and collaborative efforts to advance drug quality testing.

Pharmaceutical manufacturers in Europe and other industrial nations similarly are working to ensure equitable access to vaccines and treatments in future pandemics, as seen in a framework devised by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) to improve responses to future health emergencies. A declaration issued in July calls for the assessment and identification of successes in pathogen surveillance and vaccine development and distribution during the pandemic. The organization calls on biopharma companies to help regulators strengthen pandemic preparedness and response capabilities to help accelerate the delivery of vaccines, drugs, and diagnostics in their regions.

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

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

Privacy hurdles

One obstacle to global biomedical regulatory harmonization, however, arises from an EU effort to revise and strengthen its data privacy framework, despite the potential for blocking regulatory access to necessary clinical trial information and adverse event reports. The EU’s General Data Protection Regulations (GDPR), adopted in 2018, aims to limit the release of individual information related to a range of personal activities, including health care. Unfortunately, these policies have created difficulties for FDA bioresearch monitoring program (BIMO) inspections and for sponsors submitting information on patients in new drug applications and other documents.

A report from FDA’s Europe Office, posted in August, describes how the GDPR prevents FDA BIMO investigators from reviewing and copying clinical health data involving EU citizens participating in multinational clinical trails and in reviewing certain demographic and other information normally included in applications sent to the agency. While the EU data framework aims to protect private information on a range of activities, the resulting limits on FDA’s ability to assess EU health information pose difficulties in advancing a global clinical research framework and common regulatory policies.