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EU Clinical Trials Directive

Two other documents are relevant to clinical trials the World Health Organisation (WHO) Guidelines for Good Clinical Practice for trials on pharmaceutical products, still used for clinical trials in some parts of the world, and the new EU Clinical Trial Directive. ... [Pg.203]

In Europe, the new EU Clinical Trial Directive requires all, non-commercial and commercial, clinical trials to be conducted to the GCP standard. [Pg.269]

The EU Clinical Trials Directive (2001/20/EC) and associated guidelines and Directives (such as the Good Clinical Practice Directive draft... [Pg.313]

In the United Kingdom, healthy volunteer studies were subject to self-regulation by the pharmaceutical industry and consequently only the clinical trials in patients had to be covered by a CTC. However, as stated earlier, clinical trials in the UK are now regulated under EU Clinical Trials Directive (2001/20/EEC) fully implemented in the UK. [Pg.484]

The EU Clinical Trials Directive contains specific provisions regarding the conduct of clinical trials, including multicentre trials, on human subjects. It defines clinical trial as any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to... [Pg.484]

Prior to the introduction of EU Clinical Trials Directive, there were four ways of seeking approval for the commencement of clinical trials in the United Kingdom. These were by means of a Clinical Trial Certificate (CTC), a Clinical Trial Exemption (CTX), a Doctor s and Dentist s Exemption (DDX) or as a Clinical Trial on a Marketed Product (CTMP). Each required provision of a detailed protocol of the proposed trial. [Pg.500]

Table 1 EU Clinical Trials Directive Principal Elements of Articles and Primary Applicable Draft Guidelines or Guidance Documents (December 2003) for Implementation... Table 1 EU Clinical Trials Directive Principal Elements of Articles and Primary Applicable Draft Guidelines or Guidance Documents (December 2003) for Implementation...
All formulations for administration to humans must be prepared in compliance with good manufacturing practice (GMP) and the certificates of analysis must be provided. The European Clinical Trials Directive requires that details of the formulations be provided to, and approved by, regulatory authorities and a qualified person at the investigator site(s). In principle, the Directive has been in force throughout the EU since May 2004 though it has been implemented at various times in different member states. The Directive applies to healthy volimteer as weU as patient studies. The requirements for pharmaceutical products for administration to humans are summarised in Box 4.6. [Pg.151]

As well as domestic legislation, there is extensive European legislation governing member states. The European Community has over the years established measures to harmonize the regulation of medicines throughout Europe. In 2001, all European Community Directives adopted between 1965 and 1999 on the regulation of medicines were consolidated into a Community Code . At the time, the Code could not incorporate the new Clinical Trials Directive harmonizing EU controls on the approval and conduct of clinical trials (i.e. Directive 2001/20/EC). The Community Code has, however, since been amended to take into account the Directive s ethics. [Pg.599]

There is a considerable difference in the standard and type of information required by the various national regulatory authorities throughout the world. For example, until recently it was possible to perform clinical trials within some European countries without submission of any manufacturing information in other European countries Phase I clinical trials could be performed solely on the permission of a local ethics committee or just a doctor or dentist s approval. Requirements have now been harmonised across the EU with the Clinical Trials Directive discussed previously. Further attempts at harmonisation continue through ICH or are being driven by various MRAs. In the USA, a considerable amount of information has always been required for all phases of clinical trial from Phase I to Phase III. [Pg.18]

For all investigational medicinal products (IMPs) used in a clinical trial EU Directive 2001/20/EC ( CUnical Trial Directive ) and GMP Annex 13 are applicable [6, 7], see Sect. 35.5.10. The clinical trial directive has recently been replaced by the new and less stringent EU regulation 536/2014 [8,9]. In this regulation, GMP and a manufacturing license will no longer be required for the preparation of diagnostic radiopharmaceuticals used in clinical trials when they are prepared in a hospital radiophaimacy from licensed sources and used within the Member State. [Pg.313]

Two directives were recently introduced to harmonise the conduct of clinical trials in the EU. These are ... [Pg.78]

The relevant regulations governing the conduct of clinical trials in the U S are shown in Table 5.4. As they also reflect the principles of GCP, they are quite similar in requirements to those of the E U. However, because they apply to a single jurisdiction, they are framed to provide more prescriptive detail than can be found in the equivalent EU directives. Similarly, they are supported by the ICH- and FDA-specific guidelines. As most of the practices are the same as discussed in the previous section, the chapter will now just examine some of the aspects that are unique to the US regulations. [Pg.89]

EU Directives 2001/20/EC and 2005/28/EC set out the new rules and regulations for the approval and conduct of clinical trials in Europe. Member states had to enact the Directives into national legislation and put them into effect by May 1,2004. [Pg.252]

Directive 2001 /20/EC of the European Parhament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Eur-Lex. Official Journal of the European Communities 2001, L121 Vol. 44 34 4. http / / europa.eu.int/eur-lex/. [Pg.174]

In the past, various individuals and organisations have claimed to own the data produced from a clinical trial, including the state, the sponsor, the investigator and, in some cases, the patient or study subject. It is certainly true that with the advent of the EU Directive on Data Protection, the claim of ownership to his or her data by the patient or study subject has been strengthened. Unfortunately, there is no clear ownership of clinical data except that of society. Even then, society needs to respect the confidentiality and other wishes of individual subjects who have been clinical trial participants. Is there a difference in ownership between data produced from product-driven research to that produced in policy-driven therapeutic research ... [Pg.232]

Since the implementation of the EU Directive 2001/20/EEC on clinical trials in the United Kingdom on 1 May 2004, all clinical trials now... [Pg.499]


See other pages where EU Clinical Trials Directive is mentioned: [Pg.311]    [Pg.500]    [Pg.501]    [Pg.140]    [Pg.160]    [Pg.428]    [Pg.638]    [Pg.631]    [Pg.89]    [Pg.311]    [Pg.500]    [Pg.501]    [Pg.140]    [Pg.160]    [Pg.428]    [Pg.638]    [Pg.631]    [Pg.89]    [Pg.313]    [Pg.323]    [Pg.392]    [Pg.445]    [Pg.253]    [Pg.506]    [Pg.30]    [Pg.79]    [Pg.287]    [Pg.85]    [Pg.240]    [Pg.257]    [Pg.392]    [Pg.502]    [Pg.52]   
See also in sourсe #XX -- [ Pg.205 , Pg.239 , Pg.499 ]




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