The pharmaceutical industry has always experienced a trade-off between the need to innovate and the difficulties of doing so in such a tightly regulated industry. It is not only stringent regulation that discourages the development and implementation of innovative technologies: the element that seems to hinder the innovation process more than any other is thelack of regulatory harmonization at the global level.
This is supported by the Report 2024 on Pharmaceutical Innovation (Enabling Global Pharmaceutical Innovation: Delivering for Patients) by the International Society for Pharmaceutical Engineering (ISPE), based on a survey that gathered testimony from nearly 400 industry professionals interviewed about the difficulties companies face in translating potential innovations into products for patients.
While acknowledging the efforts of various regulatory authorities (such as the FDA and EMA) to promote the adoption of advanced technologies in pharmaceutical manufacturing, the report highlightsthe difficulties created by regulations that are not always adaptable to new technologies and often differ from one country to another.
The results of the survey
The main barrier highlighted by the report is regulatory: 48 percent of respondents indicated that regulatory challenges are considered much more relevant than other factors in determining the development of innovative technologies.
In particular, more than half of the respondents cited “conventional regulatory requirements that do not apply to new technologies (29.6 percent)” or the lack of global harmonization of regulations and guidelines (19.7 percent) as the main obstacle.
The latter element especially limits the development strategies of multinational companies, which are forced to adapt their technological solutions to the specific requirements of each country, resulting in additional costs and significant delays.
Concern about regulatory aspects also stems from the not always smooth experience in dealing with regulatory authorities:only 20.4 percent obtained approval without delays or barriers, and 28.5 percent encountered regulatory differences between authorities that led to requests for changes in technical parameters or additional unforeseen requirements (see chart sequence).
Lack of knowledge of the tools
However, it should be emphasized that the tools fielded by regulatory authorities have not yet found their full expression.
The survey revealed a surprising lack of awareness and utilization of initiatives such as the FDA’s Emerging Technology Team (ETT) and the EMA’s Quality Innovation Group (QIG), designed precisely to facilitate corporate adoption of advanced technologies:
as many as62.3 percent said they were unaware of the existence of the ETT and 69.8 percent of the QIG. It is not surprising, then, that only 22 percent of companies interacted with the ETT and just 14.5 percent had contact with the QIG.
Relationships with regulatory authorities
Pharmaceutical companies’ experiences with regulatory authorities vary widely, particularly between the largest and smallest markets. In major markets, such as the United States and Europe, companies have found a more innovation-friendly environment:
Almost 60 percent of respondents were positive about the work of FDA (mainly due to the ETT program) and EMA. However, 40 percent complained of poor receptivity, especially from authorities in regions outside the US and Europe.
In smaller markets,regulatory authorities tend to follow in the wake of large markets but often prove even more cautious and conservative, demanding further testing, even when technologies have already been validated in large markets. This approach causes delays and additional costs that discourage companies from introducing innovations in these markets.
Strategic Recommendations
In light of the survey results, the report proposes a set of recommendations to reduce regulatory barriers and incentivize innovation:
– Global Harmonization: encourage greater convergence among global regulations through multilateral initiatives, thereby reducing operational costs and approval times.
–Use of Regulatory Support Programs: increase awareness and use of programs such as ETT and QIG, which provide pathways for dialogue and cooperation with regulators to facilitate the introduction of innovative technologies.
– Harmonized inspections and mutual acceptance: create mechanisms for mutual recognition of GMP inspections among different regulatory authorities to reduce duplication and streamline compliance processes.
