Regulatory Inflation in Pharmaceutical Drug Development?

Apply

Regulatory Inflation in Pharmaceutical Drug Development?

Journal Title: Drug Designing & Intellectual Properties International Journal - Year 2018, Vol 1, Issue 2

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. The Health Canada (HC) website, more precisely the Drug &Health product inspections section [1] is listing 802 pages of cGMP audit results from virtually all Canadian establishment license holders. Even though compliant, the vast majority of them were listed as having inadequate quality systems. Comments such as: The handling of standard operating procedures for good manufacturing practices was inadequate, the written procedures for recalls were inadequate, the education, experience, and/ or oversight of the individual in charge of the quality control department was inadequate, to name but a few, can be read everywhere across the site. Compliant CMOs complain privately that labeling them as inadequate on the public domain, resulted in drops of direct business revenues and a weakening of their competitiveness. Indeed, foreign clients that would like to export their business in Canada are misinformed through HC website and get the impression that Canadian CMOs are problematic. In contrast FDA and EMA do not publish the same kind of data, through detailed documents and audit reports from compliant organizations. At the FDA cGMP audit reports exist and are on the public domain but recently both EMA and FDA have published the first report from the FDA-EMA pilot program for the parallel assessment of qualityby- design elements of marketing applications [2].

Authors and Affiliations

François-Xavier Lacasse

Keywords

EP ID EP585934
DOI 10.32474/DDIPIJ.2018.01.000110
Views 198
Downloads 0