Biomedical research is advancing rapidly and a key part its advancement is in the analytical capabilities allowing comparison between a reference biological product and a biosimilar product. In “Comparison of Data Requirements for the Approval of a Biosimilar Versus the Reference Medicine,” senior regulatory affairs consultant Olivia McBride defines both biologics and biosimilars and explains how and why the two differ in terms of their organic natures. She also guides the reader through the biologic vs. biosimilar developmental and testing stages and through agency approval and postmarketing surveillance.
As the cost to bring therapies to market is ever increasing and demand for better, more targeted drugs and vaccines continues to grow, new technology has become a major driver to expand the development pipeline and get products to patients faster. In “Transforming Regulatory Operations,” GSK executives Eckart Schwarz and Adrian Cottrell make the business case for reorganizing its regulatory operations function, centralizing regulatory processes and implementing cloud-based technology to modernize regulatory information management. The authors describe the journey toward productive change in an effort to improve efficiencies, maintain compliance with new standards and gain greater internal alignment.
Changing Global Regulatory Landscape
The Chinese regulatory system for marketing authorization differs from other regulatory systems, especially with regard to inspection and analytical testing requirements. As part of the Marketing Authorization (MA) procedure for pharmaceutical products in China, the Chinese National Medical Products Administration (NMPA) normally requires a manufacturing site inspection to be performed and for analytical test methods to be validated, prior to granting an MA. Regualtory expertYingying Liu summarizes new guidance released by the Chinese Drug Evaluation (CDE) Agency in “China NMPA Publishes new Notification on Regulatory Inspection and Analytical Testing Documentation.”
India’s Ministry of Health and Family Welfare (MoHFW) has published the final version of New Drugs and Clinical Trials Rules, 2019. In “India’s New Drugs and Clinical Trials Rules: An Industry Perspective,” Parveen Jain and Rahul Chauhan explain the new regulatory pathway, including the changes and their impact on industry and clinical trials. The experts cover product registration, changes to clinical trials rules, revisions to “new drug” definitions, postmarketing studies, orphan drug registration, ethics committees, fees and waivers and the importation and manufacture of unapproved new drugs.
Requirements for cleanrooms are among the most critical issues of Good Manufacturing Practices (GMPs), but differences between requirements in the US and EU could cause confusion and misunderstandings that could pose safety risks. GMP expert Aleksandr Fedotov discusses the contradictions between the US and EU requirements for cleanroom GMPs in “FDA and EU GMP Annex 1 Differences in Cleanroom Specifications” and specifies particle concentration for cleanrooms “at rest,” particle contamination in the air, start-up testing vs. routine monitoring, risk analysis and “interlocking” doors. He suggests the need for a globally harmonized GMP for cleanroom operation based on practical experience and scientific evidence.
There are several reasons for a company’s pursuit of accelerated development pathways for a new drug or biologic. Regulatory expert Bridget Heelan presents several reasons and summarizes accelerated pathways for regulatory approval for new drug or biologic development in the European Union (EU) in “EU Accelerated Pathways.” She presents requirements for conditional marketing authorization, authorization under exceptional circumstances, accelerated assessment and Priority Medicines Scheme (PRIME) in addition to accelerated pathway requirements associated with orphan drug designation.
Global Regulatory Strategy
The introduction of the internet in 1989 and the subsequent connection of critical medical systems in the late 1990s has improved the quality and efficiency of healthcare. However, this connectivity introduced additional risks to patient care and privacy. In “Medical Device Cybersecurity Regulatory Pathway,” medical device expert Carolyn Wright discusses the changes in technology and the need for cybersecurity, recent developments in cybersecurity regulatory and postmarketing requirements and cybersecurity risk management programs. In addition to presenting regulatory history, she includes some best practices for medical device product development teams who are looking to design in cybersecurity.
