DRW Monthly
May 2007
Issue No. 6

The Czech Republic's Harmonization of its Clinical Research Regulations with the EU CTD

Since the Czech Republic's entry into the European Union on 1 May 2004, the country has made significant progress in adapting its clinical research policies to those laid down in the EU's Clinical Trials Directive (2001/20/EC) (EU CTD). The process of transposing the EU CTD into national law began in the Czech Republic a few years prior to its accession. In 2003, the Czech government adopted an amendment to its Drugs Act 79/1997 with the passage of the Act 129/2003, also known as the "harmonisation amendment." In addition to amending provisions central to human medicinal product clinical research practice, the Act also modified the conduct of veterinary product clinical trials as well as requirements pertaining to the registration, production and distribution of medicinal products.

The main provisions affected by the Act concern patient protection, ethics committees, multi-centric studies and adverse event reporting requirements. Using the EU CTD as the basis for shaping its own policies, the Czech government has incorporated several requirements that place increased emphasis on the protection of patient rights, security and health. The Act introduces an obligation to provide an insurance policy for the patient which places "liability of damage on behalf of the sponsor" and "on behalf of the investigator."(1). Moreover, a provision has also been included that authorizes obtaining the patient's consent when he is unable to do so himself through a legal representative who acts on the patient's behalf. If no legal representative has been appointed or is unavailable, the investigator must provide a procedure for including patients in the protocol as well as obtain an affirmative statement from the ethics committee which approves this protocol. The responsibility for properly addressing these situations has been shifted largely on to the investigator and has simultaneously placed power of authority in the presiding ethics committee.

The regulation of ethics committees has also been considerably amended. As part of its evaluation of a clinical trial, an ethics committee must now incorporate criteria delineated in the EU CTD including a consideration of:

• the relevance of the clinical trial and trial design
• the suitability of the investigator and supporting staff
• the protocol
• the quality of the facilities; and
• the investigator's brochure
  

  In conjunction with the amended ethics committee operations, the Act regulates the performance of multi-centric clinical trials. Once the Czech State Institute of Drug Control (SIDC) issues prior approval, the Ministry of Health may appoint an ethics committee to issue a single affirmative statement on a multi-centric clinical trial. All other local ethics committees must comply with the single opinion issued.
  

  The other area newly regulated by the Act concerns adverse event reporting requirements for clinical trials. The investigator is now required to report any serious undesirable incidents or Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) to the ethics committee and the sponsor within 15 days of the event's occurrence. The sponsor, in turn, maintains detailed documentation of all notified incidents and must provide this documentation to the SIDC upon request. The SIDC is responsible for entering information about these serious unexpected adverse effects into EUDRACT, a database of all EU clinical trials originating from 1 May 2004.
  

  In spite of its advances in integrating the EU CTD principles, the Czech government, along with its Central and Eastern European neighbors, still has work ahead to fully incorporate the administrative provisions of the EU CTD into national law. Differences with respect to interpreting the application process and the Competent Authority's view of his or her role and responsibilities in carrying out clinical research guidelines still vary widely from country to country. The ultimate goal should be a common understanding and approach to EU CTD concepts among all the EU member states.
  
  Related Resources
  

• Czech Republic Ministry of Health (in Czech)
  

• Clinical Trials in Eastern and Central Europe
  

• Directive 2001/20/EC of the European Parliament 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
  

• European Clinical Trial Regulations Undergo a Slow Revolution
  

• Legal Regulation of Clinical Trials of Human Medicinal Products in the Czech Republic
  

• The Impact of the EU Clinical Trials Directive on Current Clinical Research Practices
  
  

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  (1) Legal Regulation of Clinical Trials of Human Medicinal Products in the Czech Republic
  
  
  

  If you desire further information about this topic or any other regulatory issue, please feel free to contact me:

  Diane Whitworth
  DRW Research & information services, LLC
  (tel.) 301.916.9669
  drwresearch@comcast.net
  

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