Many of the dynamic challenges facing the industry are unanticipated regulatory issues. The pharmaceutical industry is among the most regulated business sectors, and the bar for approval of regulatory applications has steadily risen as knowledge of chemistry, manufacturing, and analytical technology has expanded. Inspection scrutiny has extended beyond confirmation of commercial readiness and evaluation of quality systems and is now concentrated on process parameters and manufacturing sustainability. In addition, unprecedented globalization, which has introduced new market opportunities, has contributed to the emergence of complicated and precarious supply chains that attract increased regulatory concern. When seeking to build an effective supply chain for global markets, stakeholders managing diverse globalization efforts face divergent and often variable regulatory expectations across the many different regions where they operate.
Since its inception in 1980, ISPE has invited regulators to participate at conferences so attendees can learn about industry innovations and share perspectives on the global regulatory landscape. Over the years, this knowledge exchange evolved and expanded to address emerging quality issues as a concerted, prospective, and deliberate objective. With the advent of accelerated development and scientific and technical innovations, new regulatory policies were proposed through ISPE’s Pharmaceutical Quality Lifecycle Implementation® (PQLI®) initiatives as accommodations to fundamental regulations and regulatory precepts. Although the focus on pharmaceutical technology remains a primary motivation for ISPE outreach to regulators, patient-centric quality initiatives with particular emphasis on improving submission and assessment efficiency also warrant effective engagement and significant collaboration between industry and regulatory authorities.
Regulatory Steering Council’s Role and Priorities
In early 2017, the ISPE International Board of Directors authorized the establishment of the Regulatory Steering Council, a strategically focused advisory group with primary responsibilities to develop, prioritize, and reconcile regulatory policy issues through ISPE on behalf of the pharmaceutical industry.Winfield, C. “Regulatory Update: New Regulatory Steering Committee.” Pharmaceutical Engineering 38, no. 1 (January-February 2018): 20–21. https://ispe.org/pharmaceutical-engineering/january-february-2018/regulatory-update-new-regulatory-steering The Regulatory Steering Council’s role is to:
- Provide regulatory advice and strategic direction for ISPE
- Cultivate partnerships with regulatory authorities and provide an effective forum to address and reconcile regulatory policy and global harmonization issues
- Connect, align, integrate, and prioritize ISPE regulatory strategies
The Regulatory Steering Council serves as the strategic regulatory arm on behalf of the ISPE International Board of Directors. Under this umbrella, the Regulatory Quality Harmonization Committee (RQHC) and PQLI® identify, develop, research, and issue industry positions, responses, and guidelines to regulatory concerns. The current list of ISPE regulatory priorities includes the following topics:
- Annex 1: Input on revision to the European Commission
- Cell and gene therapy
- Continuous manufacturing
- Drug shortage prevention:
- Business continuity management plan
- Communications with health authorities
- ICH Q12
- Patient-centric quality standards
- Personalized/mobile manufacturing
- Pharmaceutical quality:
- Quality maturity framework
- Cultural excellence
- Pharmacopoeia harmonization
- Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP inspections mutual reliance
- Process validation
The Regulatory Steering Council recommends a limited number of regulatory priorities to the ISPE Board, and, on occasion, it has assessed additional contemporary regulatory issues on behalf of or in collaboration with other industry leadership organizations. The Regulatory Steering Council is currently discussing two initiatives—mutual reliance for inspections and pharmacopoeia harmonization, which were prompted by the Global Pharmaceutical Manufacturing Leadership Forum (GPMLF)—to determine ISPE’s appropriate role and its capacity to provide support, industry metrics/impact analysis, and training on behalf of industry.
Advancing Industry-Regulator Collaboration
Recently, several efforts focused on regulatory efficiency have been proposed through issuance of multiple regulatory guidelines globally. Among the innovative initiatives are Knowledge Assessment and Structured Application; Pharmaceutical Quality/Chemistry Manufacturing and Controls; and the multi-region assessments (Mutual Recognition Agreements, Mutual Reliance Initiatives, Australia, Canada, Singapore, and Switzerland consortiums, etc.). Regulators are recognizing that the efficiency of their application reviews must improve to get medicines to patients faster and with improved quality assurance. However, the need for improved global convergence and harmonization of standards is often at odds with efforts to increase assessment efficiency.
Patient-centric motives should be paramount for all stakeholders.
Across the global landscape, there is also a critical gap between regulatory efficiency, patient-centricity, and global harmonization; this gap becomes very visible when discussing supply of products to the patients who need them. On the one hand, improved assessment efficiency may positively benefit certain health authorities but consequently impose inefficiencies on industry. On the other hand, increased submission efficiency may assist industry but introduce challenges to health authorities in their respective assessment paradigms. In both cases, the “efficiency” strategies may compromise the expediting of important medicines to patients. The Regulatory Steering Council believes a collaborative approach among members from regulatory authorities and industry is most conducive to improving effective efficiencies that accommodate the unique accountabilities of both regulatory and industry partners. Patient-centric motives should be paramount for all stakeholders, and any strategic efforts should be rooted in a collective understanding of and respect for the relevant similarities and differences between regulators and industry.
ISPE has a crisp, clear, and comprehensive vision statement that includes regulatory strategy as a collaborative endeavor:
Provide solutions to complex pharmaceutical industry challenges through manufacturing innovation, member and workforce development, technical, regulatory, and compliance collaboration.
Conclusion
Through the strategic assessment from the Regulatory Steering Council, ISPE is continuing its focus on priority initiatives that are important to industry; these initiatives will resonate even more when developed via alignment and strong collaboration with regulatory authorities. Though this approach provides clear benefits for both regulators and industry, the most significant benefits will be realized by patients worldwide.
