{"id":21098,"date":"2024-10-21T15:07:14","date_gmt":"2024-10-21T15:07:14","guid":{"rendered":"https:\/\/makingpharmaindustry.it\/?p=21098"},"modified":"2024-10-21T15:08:31","modified_gmt":"2024-10-21T15:08:31","slug":"the-legal-challenges-of-pharma-innovation","status":"publish","type":"post","link":"https:\/\/makingpharmaindustry.it\/en\/manufacturing\/technology\/the-legal-challenges-of-pharma-innovation\/","title":{"rendered":"The legal challenges of pharma innovation"},"content":{"rendered":"

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<\/strong>.<\/p>\n

This is supported by the Report 2024 on Pharmaceutical Innovation (Enabling Global Pharmaceutical Innovation: Delivering for Patients<\/a>) by the International Society for Pharmaceutical Engineering (ISPE<\/a>), based on a survey that gathered testimony from nearly 400 industry professionals<\/strong> interviewed about the difficulties companies face in translating potential innovations into products for patients.<\/p>\n

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<\/strong>.<\/p>\n

The results of the survey<\/h2>\n

The main barrier highlighted by the report is regulatory: 48 percent<\/strong> of respondents indicated that regulatory challenges are considered much more relevant than other factors<\/strong> in determining the development of innovative technologies.<\/p>\n

In particular, more than half of the respondents cited “conventional regulatory requirements that do not apply to new technologies (29.6 percent)”<\/strong> or the lack of global harmonization of regulations and guidelines (19.7 percent)<\/strong> as the main obstacle.<\/p>\n

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.
\nConcern about regulatory aspects also stems from the not always smooth experience in dealing with regulatory authorities:only 20.4 percent obtained approval without delays<\/strong> 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).<\/p>\n