IDEAS home Printed from
   My bibliography  Save this article

Modificari Determinate De Regulamentul Europeean Privind Studiile Clinice Changes Determined By The European Clinical Trials Regulation


  • Sorina-Mihaela BALAN

    (Lecturer PhD, University of Dimitrie Cantemir, Targu Mures, ROMANIA.)


Doctors should do what is best for their patients, should not do any harm, and allow individuals to manage their own healthcare choices. These principles apply to medical research in tandem with clinical practice. How do we know the best treatment for a particular condition? How do we know that a new treatment (medicine) does not cause any harm? We could guess, "try and see what's going on," or we could design a clinical trial with defined endpoints, a statistical analysis, and monitoring adverse events to gain proof of benefit. Clinical studies provide some knowledge to practice medicine in an ethical manner. Are there regulations on clinical trials of medicinal products? What is the framework for authorization of clinical trials in the EU? The Regulation UE establishes a uniform framework for the authorization of clinical trials in all Member States through a single evaluation of the results, facilitating international cooperation in clinical trials, in the development of special treatments. Also, simplified experimentation rules are introduced which provide authorized medicines or used medicinal products based on scientific evidence published. A challenge for stakeholders is the complex processing procedures and shorter implementation times in comparison to the previously regulations, for the development of innovative medicines.

Suggested Citation

  • Sorina-Mihaela BALAN, 2020. "Modificari Determinate De Regulamentul Europeean Privind Studiile Clinice Changes Determined By The European Clinical Trials Regulation," Curentul Juridic, The Juridical Current, Le Courant Juridique, Petru Maior University, Faculty of Economics Law and Administrative Sciences and Pro Iure Foundation, vol. 81, pages 58-65, June.
  • Handle: RePEc:pmu:cjurid:v:81:y:2020:p:58-65

    Download full text from publisher

    File URL:
    Download Restriction: no

    More about this item


    Clinical trias; new regulation; data protection; clinical trials.;
    All these keywords.

    JEL classification:

    • K32 - Law and Economics - - Other Substantive Areas of Law - - - Energy, Environmental, Health, and Safety Law
    • K31 - Law and Economics - - Other Substantive Areas of Law - - - Labor Law


    Access and download statistics


    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:pmu:cjurid:v:81:y:2020:p:58-65. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    We have no bibliographic references for this item. You can help adding them by using this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Bogdan Voaidas (email available below). General contact details of provider: .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.