ABSTRACT

The regulatory process for assessing medical products can be lengthy and complex, which can delay their availability to patients. In France, Germany, and the UK, there have been efforts to streamline the regulatory procedure in order to accelerate the assessment of medical products. These efforts have included the establishment of joint assessment committees, the use of common data sets, and the development of harmonized guidelines. As a result of these efforts, the time it takes to assess medical products in these countries has been reduced by an average of 30%. This has enabled patients to access new medical products more quickly, improving their health outcomes. The streamlining of the regulatory procedure has been a success in France, Germany, and the UK. However, there are still some challenges that need to be addressed. For example, the regulatory authorities in these countries need to ensure that the quality of the assessment process is not compromised. Additionally, the regulatory authorities need to work with the pharmaceutical industry to ensure that the new procedures are efficient and effective. Overall, streamlining the regulatory procedure for assessing medical products is a positive step that can potentially improve patient access to new and innovative therapies. Keywords: Research, CHMP, AAP, HTA, MAA
Publication date: 01/08/2024

https://ijbpas.com/pdf/2024/August/MS_IJBPAS_2024_8271.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.8.8271