Immunization standards

Mission

To support and promote the strengthening of the regulatory oversight during the clinical development of vaccines, authorization and inspection of clinical trials, evaluation of investigational products, evaluation of registration dossiers and post-market surveillance in developing countries.

To achieve this mission, the DCVRN members will:

  • Encourage and facilitate information exchange among the NRAs on national laws, regulations and establish guidelines and policies relating to the regulatory control of domestic or imported vaccines, in particular regulatory oversight of clinical trials (clinical trial authorization and inspections) and clinical data evaluation;
  • Develop guidelines or procedures relevant to the regulatory oversight during clinical development of vaccines, authorization and inspection of clinical trials or evaluation of registration dossier;
  • Discuss NRA policies aimed at advancing mutual understanding of their respective levels of expertise and identify the potential for collaboration and joint regulatory activities;
  • Identify internationally recognized standards consistent with WHO guidelines for clinical evaluation of vaccines. If guidelines are not available, the DCVRN may propose ideas for consideration of WHO relevant expert or advisory groups and collaborate in the development of such guidelines;
  • Enhance the expertise and effectiveness of the NRAs in vaccine evaluation during clinical development, including clinical aspects and investigational product evaluation, and suitability of clinical data for registration (evidence of safety and efficacy for the target population); and
  • Promote information exchange through: encouraging enrolment of Network participants in training courses on clinical evaluation developed by WHO; inviting relevant clinical and regulatory experts to present at DCVRN meetings, as appropriate; coordinating joint activities; providing expert assistance for regulatory evaluation, upon request; and any other relevant activities as agreed by DCVRN members and WHO.
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Last update:

30 May 2012 16:28 CEST