A critical appraisal of the parity of international pharmaceutical products
thesisposted on 2023-08-30, 20:22 authored by Paul J. Cummings
This research project sought to critically assess the parity, with respect to safety and quality, of internationally manufactured drug products when contrasted against domestically manufactured products. The pharmaceutical industry is a global industry with major markets importing up to 80% of drug products utilised by their citizens, it is essential that all manufacturers meet the same minimum quality standard. The researcher has utilised a mixed methods approach of questionnaire and interviews of subject matter experts and regulators. In conjunction with the interviews and surveys, key data was harvested from regulatory agency publications and under freedom of information requests from The United States of America Food & Drug Administration, The United Kingdom’s Medicines and Healthcare Products Regulatory Agency and Australia’s Therapeutical Goods Administration. The interviews and surveys demonstrated a high level of concern that internationally manufactured drug products were of inferior quality to those manufactured domestically. In addition Regulatory agency data demonstrated for the past six years large decreases in the number of regulatory inspections overall and an even greater decrease in foreign site inspections. In one documented instance product recalls had increased by 500% in the past six years. Participants in this research study overwhelmingly felt that the issues on non-parity were due to a number of factors including ambiguous and conflicting regulations, poor or decreasing Regulatory agency oversight, a lack of expertise and a lack of engagement and sharing best practice. This research concluded that the generation of a model for total product quality and a global standard would be beneficial for the formation of a global framework for a minimum quality standard, it would aid industry and regulators in assessment of quality and ultimately aim to improve patient safety.
InstitutionAnglia Ruskin University
- Accepted version