WHA16.36 - Clinical and Pharmacological Evaluation of Drugs. WHA resolution; The Sixteenth World Health Assembly, 1963
(1963; 2 pages) [French] [Russian] [Spanish]

  1. REQUESTS Member States
    1. to communicate immediately to WHO
      1. any decision to prohibit or limit the availability of a drug already in use,
      2. any decision to refuse the approval of a new drug,
      3. any approval for general use of a new drug when accompanied by restrictive provisions,

        if these decisions are taken as a result of serious adverse reactions; and

    2. to include in this communication as far as possible the reasons for the action taken and the nonproprietary and other names, and the chemical formula or the definition ;
    1. RECOGNIZES the importance of accurate appraisal, at the national level, of the toxic effects of drugs;
    2. and
    3. INVITES Member States to arrange for a systematic collection of information on serious adverse drug reactions observed during the development of a drug and, in particular, after its release for general use;
  2. REQUESTS the Director-General
    1. to transmit immediately to Member States the information received under paragraph 2;
    2. to study the value and feasibility, including the administrative and financial implications, of WHO collecting from and disseminating to Member States
      1. the non-proprietary and other names, chemical formulae and definitions of new drugs released or approved,
      2. the information contained in 3 (b) above;
    3. to continue the study of the possibility of formulating, and of seeking international acceptance of, basic principles and requirements applicable to the toxicological, pharmacological and clinical evaluation of drugs; and
    4. to pursue action in the matter and report to the Executive Board and to the Seventeenth World Health Assembly.
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