الفهرس 
عملية الاكتشاف الدوائي - الجانب الموضوعييوجد فقط 14 صفحة متاحة للعرض العام
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المستخلص
This study aims at providing a proposal to solve the lack of legislations that control the drug development process.
This process is of a paramount importance, yet very risky.
Despite both, it lacks the legal coverage in the Egyptian legislation. Actually, there is no legal rule neither to control the process from the beginning to the end nor to organize the
relationship between the parties involved in it.
The study is divided into two parts; the first deals with the objective aspects of the drug development process. It discusses related legal issues, such as the legal nature of the
relationship between the parties. This part is an attempt to extend the application of the general rules of the civil law to apply to the drug development process.
In addition, this part spotlights certain legal issues related to the drug development process that needs to be dealt with in specific rules. The most important issue is the clinical
trials.
The second part of this study deals with the procedural part of the drug development process. It explores the legal systems in other countries such as the United States of America and the United Kingdom and how legislations in these countries control this process. The judicial review for this process and the procedures before the competent courts in both countries are also considered.
The study is followed by a proposal to control the drug development process in Egypt. This suggestion is based mainly on three elements:
1. Enact a new law to control the drug development process.
2. Determine the administrative authority to which the control and supervision of this process are to be
assigned.
3. Determine the competent court.
At its end, the study presents a group of suggestions, some are concerned with the current situation in order to ensure the required legal balance between the parties of the process, others deal with what is necessary to handle similar cases in the future, and the latest group tackles the ethical aspects of the clinical trials.