Advance global collaboration for drug testing, regulation and manufacturing
The FDA supports joint reviews, common research policies, and modern production methods around the world.
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 collaboration to accelerate biomedical research efforts and ensure broad access to quality medicines and vaccines.
An important message from COVID-19 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 held on September 12, 2022. He warned, 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 information from pharmacovigilance and review the results.
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 Pharmacopoeia 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. quality for neglected tropical diseases, tuberculosis, and other infections. An FDA webinar explained these issues to global regulators in low-income regions, with agency experts outlining the agency’s submission and regulatory processes and collaborative efforts to advance drug testing. drug quality (1).
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 issued in July 2022 calls for the evaluation and identification of successes in pathogen surveillance and vaccine development and distribution during the pandemic. The organization calls on biopharmaceutical companies to help regulators build pandemic preparedness and response capacity to accelerate the delivery of vaccines, treatments and diagnostics to their regions (2).
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 collaborative evaluation of chemistry, manufacturing and control (CMC) data to facilitate post-approval changes and inspections in different regions (3).
The FDA also supports global clinical trials 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. Under the program, sponsors simultaneously submit applications for high-impact oncology products to participating regulators in Australia, Canada, Singapore, Switzerland, Brazil, the United Kingdom and the United States to facilitate collaboration and agreement on reviews of new cancer drugs and supplements for added indications. While the OCE coordinates the program, each regulator makes independent regulatory decisions.
The International Council for Harmonization (ICH) continues to seek agreement from regulatory authorities and industry on new and revised standards for clinical trials and quality manufacturing of drugs and biologicals. Current efforts aim to advance common strategies for the validation and selection of analytical procedures in drug testing, for the evaluation and control of impurities in drugs, and for the validation of bioanalytical assays. A new initiative is developing guidelines for including pregnant and breastfeeding women in clinical trials, while another project is mapping harmonized approaches to regulating generic drug development (4). These and other ICH initiatives will be further discussed at its annual meeting on November 15-16, 2002 in Korea.
An obstacle to global harmonization of biomedical regulation, however, stems from an effort by the European Union to revise and strengthen its data privacy framework, despite the possibility of blocking regulatory access to necessary information on clinical trials and to reports of adverse events. The EU 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 Biological Research Oversight Program (BIMO) inspections and for sponsors who submit study subject information in New Drug Applications and other documents. .
A report from the European Office of the FDA published on August 9, 2022 describes how the GDPR prevents FDA BIMO investigators from reviewing and copying clinical health data involving EU citizens participating in multinational clinical trials and clinical trials. review certain demographic and other information normally included in submitted applications. at the agency (5). 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.
- FDA, Regulatory Best Practices for
Global access to medicines, including anti-tuberculosis drugsWebinar, August 16-18, 2022.
- IFPMA, “Pharma Proposes to Work With G7 and G20 on a Joint Solution for Better Access to Vaccines and Treatments Around the World for Future Pandemics”, Press Release, July 19, 2022.
- ICMRA, “International Pilot Programs to Streamline Regulatory Assessments and Inspections–Call For Industry Applications,” press release, June 2022.
- ICH, “ICH Assembly Meeting, Athens, Greece, May 2022 A Successful Hybrid Meeting,” press release, June 1, 2022.
- H. Messick, “How a European Data Law Impacts the FDA”, FDA.govAugust 9, 2022.
About the Author
Jill Wechsler is the managing editor in Washington for BioPharm International.
Volume 35, number 10
When referring to this article, please cite it as J. Wechsler, “Advancing Global Collaboration for Drug Testing, Regulation, and Manufacturing,” BioPharm International 46 (10) (2022).