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Pharmaceutical Industry Profile
Published in Terry Jacobs, Andrew A. Signore, Good Design Practices for GMP Pharmaceutical Facilities, 2016
The Treaty of Marrakesh (2004) approved international trade in full patent protection for pharmaceutical products across industrial nations, as well as in the less developed nations. The industry boasts an investment rate of return that is four times the magnitude of that of a typical Fortune 500 company. The contract research organizations (CROs) are examples of outsourcing by innovator companies that enter into a contract for some or all aspects of development with a third party. Approximately 15%–20% of all research spending by innovator companies is now being executed through CROs. This trend has had a major impact in innovator company culture as historic R&D facilities have been sold or shuttered around the world. Innovator companies have reduced the scope of their research efforts as they focus on commercially attractive disease areas. Over the past decade, biotech, large-molecule research occupied a growing portion of new development programs. The cGMP regulations apply to research facilities that develop compounds for use in clinical phase 1 investigations (Figure 1.6).
Other Considerations
Published in Gennadi Saiko, Bringing a Medical Device to the Market A Scientist's Perspective, 2022
However, in many cases, it is not necessary to go beyond one clinical expert and build extensive clinical expertise in-house. With the proliferation of Contract Research Organizations (CROs), many functions during clinical phase can be outsourced, including recruiting test sites and participants.
Preparing healthcare, academic institutions, and notified bodies for their involvement in the innovation of medical devices under the new European regulation
Published in Expert Review of Medical Devices, 2022
Francesco Garzotto, Rosanna Irene Comoretto, Lorenzo Dorigo, Dario Gregori, Alessandro Zotti, Gaudenzio Meneghesso, Gino Gerosa, Mauro Bonin
To introduce to the market a new drug, a scientific committee of the European Medicine Agency (EMA) conducts a comprehensive evaluation of the clinical data collected from laboratory tests and clinical investigations. Clinical trials are well defined, and any study phase (I to IV) has a specific objective. Contract research organizations (CROs) are often involved in the entire process management, and their costs are sustainable for the pharma industry. Thus, once the drug has been introduced in the market, data for reimbursement and pricing evaluations are always available.