Regulatory Inflation in Pharmaceutical Drug Development?

Volume 1 - Issue 2

François-Xavier Lacasse*

Received: April 06, 2018;   Published: April 13, 2018

DOI: 10.32474/DDIPIJ.2018.01.000110

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Abstract

During the last decade, and exponentially over the last three years, numerous pharmaceutical manufacturing plants have closed their doors following current Good Manufacturing Practices (cGMP) audits from various agencies, such as FDA, EMA and Health Canada. Regulatory affairs have been evolving and so should be the audits, auditors and regulations. However, the density and interpretations of regulatory requirements have become increasingly stringent, especially with respect to sterile products, making them more difficult to develop and manufacture within reasonable time and cost. A quick search on Google shows numerous press releases from various pharmaceutical organizations reporting critical/ major deficiencies, leading to temporary or permanent closures of manufacturing plants. Furthermore, it seems that this evolving situation has not only impacted drug shortage, but these events have placed the pharmaceutical industry under a permanent state of siege. The negative impacts of regulatory inflation are a center of attention among pharmaceutical professionals.

Opinion| Regulatory Narrative Leading to Global Inadequacy of the Canadian Industry| Regulatory Inflation: The Emergence and Growth of the Compliance Industry| Generational Turnover of Inspectors and Auditors| Conclusion|