Update of regulation on cell and gene therapy to keep up with changes in the U.S.A. industrial secto
5 August 2020
From 2018 until the beginning of 2019, the United States Food and Drug Agency (FDA) announced eight recommended guidelines in cell and gene therapy. The guidelines helped the regulatory body keep up with changes in the industry and create a regulatory landscape in the field of cells and gene therapy in response to the rapid development of the industry and the common interests of the industry and patients.
Over the past two years, the rapid improvement in product development included production process consistency, quality maintenance, as well as increased production at a lower cost. Most importantly, the guidelines highlighted the application of data analytics in product quality analysis, patients’ time-series data analysis, increased inspection and review for medical treatment precision. This development trend prompted the collection of knowledge and experience in the industry. Were there mutual cooperation between the manufacturers and regulators, the legislation of new regulations supporting industrial investment, better product standards in medical treatments for diseases, such as cancer and genetic disorders, e.g., cystic fibrosis.
Two important examples of legislatures attempting to balance safety and innovation, included the rapid development of clinical trials for cancer treatment (FDA, and the treatment of cystic Fibrosis (FDA, in the United States. Both legislatures focused on the use of real data and real experience including genome sequencing to improve treatment efficiency and safety of patients.
For the benefit of patients and investors who were interested in the Thai market, Thailand’s regulation development, especially in the field of data collection, data analysis and aftercare service, would prompt the industry expansion. This expansion would further benefit patients who could not be treated by using conventional methods, including patients with cancer or rare genetic diseases, and so on. Most importantly, attention was mostly paid to new treatment development for diseases that occur in children, therefore, keeping the rules and regulations up-to-date in this information age would benefit both the patient and investment in the medical sector.
Reference
FDA. (2018). “Master Protocols: Efficient Clinical Trial Design Strategies To Expedite Development of Oncology Drugs and Biologics.” https://www.fda.gov/regulatory-information/search-fda-guidance-documents/master-protocols-efficient-clinical-trial-design-strategies-expedite-development-oncology-drugs-and
FDA. (2019). “FDA approves new breakthrough therapy for cystic fibrosis.” https://www.fda.gov/news-events/press-announcements/fda-approves-new-breakthrough-therapy-cystic-fibrosis
Life Science Leader. (2019). “Challenges Facing The Cell And Gene Sector's Regulation Landscape.”. https://www.lifescienceleader.com/doc/challenges-facing-the-cell-and-gene-sector-s-regulation-landscape-0001
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