WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Close this folderAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
View the documentIntroduction
View the documentDrafting national legislation: points for consideration
View the documentDefining the scope of the marketing authorization procedure for medicinal products
Open this folder and view contentsExample of a legislative scheme for regulating medicinal products
View the documentReferences
View the documentSelected bibliography
View the documentAppendix 1. Provisional legislative scheme for registration of pharmacy personnel
View the documentAppendix 2. Guidelines, documents and other regulatory instruments established by WHO to support drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

Selected bibliography

See also the list of references on pages 141-142.

Bankowski Z, Levine RJ, eds. Ethics and research on human subjects: international guidelines. Geneva, Council for International Organizations of Medical Sciences, 1993.

Consolidated list of products whose consumption and/or sale have been banned, withdrawn, severely restricted or not approved by governments. New York, United Nations, 1991.

Counterfeit drugs: report of a joint WHO/IFPMA workshop, 1-3 April 1992. Geneva, World Health Organization, 1992 (unpublished document WHO/DMP/CFD/92; available on request from Division of Drug Management and Policy, WHO, 1211 Geneva 27, Switzerland).

Drug regulation and developing countries. WHO drug information, 1993, 7(1): 1-3.

Dunne JF. Global harmonization of regulatory requirements: World Health Organization. In: Sixth International Conference of Drug Regulatory Authorities: report of the conference proceedings. Geneva, World Health Organization, 1993:81-82 (unpublished document WHO/DMP/ICDRA/93.1; available on request from Division of Drug Management and Policies, WHO, 1211 Geneva 27, Switzerland).

Essential drugs. World health, 1992, March-April.

Good pharmacy practice in community and hospital pharmacy settings. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fifth report. Geneva, World Health Organization, 1999, Annex 7 (WHO Technical Report Series, No. 885).

Idänpään-Heikkilä JE. WHO, ICH and global harmonization of registration requirements for pharmaceutical products. In: Proceedings of the Second International Conference on Harmonisation, Orlando, 1993. Belfast, Queen's University, 1994.

Idänpään-Heikkilä JE. WHO and harmonization of pharmaceutical regulation. WHO drug information, 1996, 10:125-126.

Jayasuriya DC. Regulation of pharmaceuticals in developing countries: legal issues and approaches. Geneva, World Health Organization, 1985.

Procedures for the selection of recommended International Nonproprietary Names for pharmaceutical substances. WHO drug information, 1992, 6(2): 14-15.

Quality pharmaceutical care - benefits for governments and the public. WHO second meeting on the role of the pharmacist, Tokyo, Japan, 31 August - 3 September 1993. Geneva, World Health Organization, 1994 (unpublished document WHO/PHARM/94.569; available on request from Division of Drug Management and Policies, WHO, 1211 Geneva 27, Switzerland).

Registration of pharmaceuticals: Tanzania. Geneva, World Health Organization, 1992 (unpublished document WHO/DAP/92.12; available on request from Action Programme on Essential Drugs, WHO, 1211 Geneva 27, Switzerland).

Report of a consultation on basic elements of drug legislation and regulatory control for developing countries. Geneva, World Health Organization, 1981 (unpublished document DAP/81.3; available on request from Action Programme on Essential Drugs, WHO, 1211 Geneva 27, Switzerland).

Report of the joint UNDCP-WHO technical consultation meeting on parallel distribution systems for narcotic drugs and psychotropic substances at the national level 16-18 June. Vienna, 1993 (unpublished document available on request from United Nations International Drug Control Programme and Psychotropic and Narcotic Drugs, Vienna, Austria, and from Division of Drug Management and Policies, WHO, 1211 Geneva 27, Switzerland).

The IFPMA compendium on regulation of pharmaceuticals for human use. Geneva, International Federation of Pharmaceutical Manufacturers Associations, 1987 (1989 Suppl.).

The rational use of drugs. Report of the Conference of Experts, Nairobi. Geneva, World Health Organization, 1987.

The regulation of pharmacists and pharmacies. A draft act for adaptation by small national drug regulatory authorities. Geneva, World Health Organization, 1994 (unpublished document PHARM/94.272; available on request from Division of Drug Management and Policies, WHO, 1211 Geneva 27, Switzerland).

The role of the pharmacist in the health care system. Report of a WHO Consultative Group, New Delhi, India, 13-16 December, 1998; report of a WHO meeting, Tokyo, Japan, 31 August-3 September, 1993. Geneva, World Health Organization, 1990 (unpublished document WHO/PHARM/94.569; available on request from Division of Drug Management and Policies, WHO, 1211 Geneva 27, Switzerland).

The world drug situation. Geneva, World Health Organization, 1988.

World development report 1993. Washington DC, World Bank, 1993.

Examples of national legislation adopted since 1988

Albania

The Drug Law, date of enactment 20 April 1994

 

Bulgaria
Degree No. 109 of 17 April 1995 promulgating the Law on Medicaments and Pharmacies with Regard to Human Medicine

(see also International digest of health legislation, 1996, 47(1):56-60, Bulg. 96.1)

Estonia
Medicinal Products Act of 19 December 1995

Ghana
The Pharmacy Act, dated 30 December 1994

(see also International digest of health legislation, 1996, 47(1):63, Ghana 96.2)

Latvia
Law on Pharmaceutical Activities of 27 April 1993

(see also International digest of health legislation, 1995, 46(2):220, Lat. 95.1)

Malawi
Drug Act of 1988

Myanmar
Drug Law of 30 October 1992

Republic of Korea
The Pharmaceutical Act, as amended up to 7 January 1994

(see also International digest of health legislation, 1995, 46(3):352, ROK 95.1)

Sierra Leone
Pharmacy and Drug Act of 1988

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