Critical review document

16. The Secretariat prepares the critical review document which is a summary of available data compiled for use by the Expert Committee in assessing individual substances. In the preparation of the critical review document, the Secretariat collects and assembles data on the substances selected for critical review, and requests information on these substances through a questionnaire to ministers of health of Member States and to other relevant collaborating information sources. The Secretariat may also be assisted by advisers and ad hoc working groups in order to produce a balanced document.

17. The critical review document is sent for information and comments to governments, institutions and organizations which have directly and substantially collaborated in its preparation or which have requested it. Examples include international narcotics control organs and relevant governmental, intergovernmental, and nongovernmental organizations in official relations with WHO. To help ensure that all material submitted to the Expert Committee is up to date, the Secretary of the Committee will circulate the agenda of the next meeting to those collaborating information sources.

18. When preparing the critical review document, the Secretariat should include, where feasible, information under the following headings:

(1) substance identification by International Nonproprietary Name (INN), chemical or other common name and trade names, other identifying characteristics, Chemical Abstracts Service (CAS) registry number

(2) chemistry

(3) general pharmacology

(4) toxicology, including adverse reactions in humans

(5) pharmacokinetics

(6) dependence potential

(7) epidemiology of use and abuse, with an estimate of the abuse potential of the substance

(8) nature and magnitude of public health problems

(9) national control

(10) therapeutic and industrial use

(11) production, consumption and international trade

(12) illicit manufacture and illicit traffic, and related information

(13) current international controls in place and their impact.

19. If abundant, the information presented under each heading will be limited to that which is essential and consistent with the need to facilitate assessment by the Expert Committee.

20. Not all the headings listed above may be covered in all instances or to the same extent. For example, it may not be possible to cover (4), (5), (7), (8), (10) and (11) for new hallucinogenic substances. The production of data in such circumstances may not be justifiable on ethical grounds. If, for any reason, the Expert Committee bases its assessment on limited data, it would need to provide full justification for reaching conclusions on incomplete data.

21. The confidentiality of information received by WHO for use in the review will be respected to the maximum if so requested by the provider. In this case, appropriate arrangements will be made for the Expert Committee to have access to the information used to prepare the critical review.