ISPE Releases Survey Report, “Enabling Global Pharmaceutical Innovation: Delivering for Patients”
25 April, 2024
Nearly 400 pharmaceutical professionals weigh in on challenges and opportunities with introducing technological innovation, citing economic factors and regulatory concerns as key barriers
The International Society for Pharmaceutical Engineering (ISPE) has released a report on its survey to uncover and address the barriers to pharmaceutical innovation, entitled “Enabling Global Pharmaceutical Innovation: Delivering for Patients.”
The report includes insights from 391 respondents from the pharmaceutical industry with a diverse mix of large to small manufacturers, contract and development organizations, suppliers, facilities and software service providers, and more, from multiple countries and reflecting multiple product modalities. The majority of responses came from innovative (brand name) companies.
The pharmaceutical industry is committed to developing innovative technology and continually improving. These survey findings identify sources of the key barriers that limit progress toward technological innovation and opportunities for improvement that increase quality assurance for patients.
Key challenges and determining factors impacting innovation are as follows:
- In general, economic factors were the primary drivers determining the cost/benefit for capital investment in innovative technology
- The current regulatory environment poses a significant challenge to implementing continual improvement and innovative technologies
- Regulatory challenges were reported by nearly half the respondents (48%) as the most significant or significantly greater than other factors in terms of influencing decisions to develop innovative technology
- The top concerns with regulators accepting innovative technology were around challenges during application reviews and a lack of globally harmonized regulations
- When the level of uncertainty associated with divergent regulatory expectations is relatively high, the potential value of an innovation relative to its return on investment becomes difficult to estimate and justify. Subsequently, according to many respondents, innovative approaches are often postponed or even terminated until after the regulatory environment is deemed to be more favorable
Key recommendations for regulators and the industry are as follows:
- Establish an efficient system that connects regulatory authorities with the industry and fosters opportunities for companies and vendors to propose and establish innovations for global consideration, acceptance, and implementation
- Align application review/assessment processes that cultivate a convergent approach to evaluate the merits of innovative technologies and produce a combined list of queries from global regulatory authorities
- Adopt a single or limited GMP inspection schedule for assessing the implementation of innovative technologies per manufacturing facility (when required) in accordance with global inspection standard
- Initiate global regulatory authority approvals that rely on mutual reliance/recognition
- Establish a predictable global regulatory authority review/assessment/inspection and approval schedule that ensures global supply chain reliability and patient access
- Introduce a globally harmonized regulatory process to support review, inspection, and approval of platform technologies, which may apply to multiple products
The regulatory environment is complex. As this report indicates, regulatory harmonization will be a critical component to enabling innovation in the pharmaceutical industry. ISPE strives to facilitate industry-wide clarity surrounding regulations. Survey reports like this one, which provide statistically significant data points drawing from insights shared by hundreds of professionals, will enable us to advance efforts between the industry and regulators and ultimately help to shape the future of the pharmaceutical industry.
As a next step, ISPE’s Enabling Global Pharmaceutical Innovation Initiative team will present proposals to multiple regulatory agencies intended to promote practical incentives for the industry and regulatory authorities to address specific challenges to innovation and continual improvement initiatives. Additionally, the ISPE team will work with industry and equipment suppliers to understand the steps needed to introduce innovative technologies and develop a “points to consider document” with key considerations about how to address specific challenges to innovation and continual process improvement.