Regulatory Inflation in Pharmaceutical Drug Development? by François Xavier Lacasse in DDIPIJ in Lupine Publishers
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.
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