Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce - EDM Research Series No. 016
(1995; 156 pages) View the PDF document
Table of Contents
View the documentACKNOWLEDGMENTS
View the documentPREFACE
View the documentEXECUTIVE SUMMARY
Open this folder and view contents1. INTRODUCTION
View the document2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT
View the document3. ACTIVITIES UNDERTAKEN: Preparations and Method of Work
Close this folder4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES
View the document4.1 Pharmaceutical Import and Consumption
View the document4.2 National Drug Policy and Essential Drugs List
View the document4.3 Infrastructure
View the document4.4 Functioning of Bodies Responsible for Regulation, Procurement and Quality Assurance
View the document4.5 Operation of the WHO Certification Scheme
Open this folder and view contents5. ANALYSIS OF RESULTS FROM EXPORTING COUNTRIES
View the document6. ANALYSIS OF RESULTS FROM INTERNATIONAL SUPPLY AGENCIES
Open this folder and view contents7. SUMMARY ANALYSIS
View the document8. CONCLUSIONS
View the documentANNEX 1: Resolution adopted by the Twenty-second World Health Assembly
View the documentANNEX 2 (a): Resolution Adopted by the Twenty-Eighth World Health Assembly
View the documentANNEX 2 (b): Certificate of Pharmaceutical Product(S)1
View the documentANNEX 3 (a): Resolution adopted by the Forty-first World Health Assembly
View the documentANNEX 3 (b): Certificate of Pharmaceutical Product(s)1 (Proposed Layout)
View the documentANNEX 4 (a): Proposed Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
View the documentANNEX 4 (b): Certificate of a Pharmaceutical Product
View the documentANNEX 4 (c): Statement of Licensing Status of Pharmaceutical Product(s) Model Statement of Licensing Status of Pharmaceutical Product(s)
View the documentANNEX 4 (d): Manufacturer’s/Official Batch Certificate of a Pharmaceutical Product
View the documentANNEX 5: Protocol for the Assessment of the Use of the WHO Certification Scheme by Importing Country
View the documentANNEX 6: List of Participants in the Study
View the documentANNEX 7: Protocol for the Assessment of the Use of the WHO Certification Scheme by Exporting Country
View the documentANNEX 8: Protocol for the Assessment of the Use of the WHO Certification Scheme in an International Supply Organization
View the documentANNEX 9: Study Instrument for Assessment of the WHO Certification Scheme by Importing Country
Open this folder and view contentsANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme
View the documentBACK COVER
 

4.2 National Drug Policy and Essential Drugs List

Of the 15 countries assessed, Benin, Kenya, Malawi, Myanmar, Tanzania, Tunisia, and Yemen have written and approved national drug policies covering aspects related to drug regulatory control, registration, procurement and quality assurance. A plan for the implementation of the drug policy exists in Benin, Ecuador, Malawi, Tanzania, Tunisia, and Yemen.

In those countries where a written and approved drug policy does not exist, one or more elements of a national drug policy e.g. regulatory control, drug registration, drug procurement, and quality assurance are being implemented. Similarly, all countries recognize the importance of an essential drugs list and use these lists for procurement in the public sector. The number of drug substances in the national lists varied from 120 to 670.

Table 2 shows the existence of a national drug policy, essential drugs list and drug legislation.

Table 2. Existence of national drug policy, national essential drugs list and legislation

Country

National Drug Policy and date introduced

Essential Drugs List

Legislation

Benin

National Drug Policy, 1991*

National Essential Drugs List, 1990

Several drug regulations exist

Cameroon

Only elements are used**

Liste Nationale des Médicaments Essentiels Utilisés dans les Formations Sanitaires, 1990

Law No. 90 035 of 10 August 1990

Central African Republic

Only elements are used**

Not official

Being developed

Ecuador

Decreto Ejecutivo 2007, 26 December 1990*

National Essential Drugs List, 1992

Code of Health, Official Register No. 158, 8 February 1977

Fiji

Only elements are used**

Essential List of the Government Pharmacy, 1991

Pharmacy and Poisons Act, 1938 as Amendment 1983

Jamaica

Only elements applied**

VEN List, 1986

Food and Drugs Act 1964, Pharmacy Act 1966, Food and Drug Regulations 1974 and Pharmacy Regulations 1974

Kenya

A draft national drug policy, 1993***

A draft Essential Drugs List, May 1993**

Pharmacy and Poisons Act 1957. Revised 1972 and 1989

Malawi

Malawi National Drug Policy, 1991*

Malawi Essential Drugs List, 1991

Pharmacy, Medicines and Poisons Act, 1978 and Regulation, 1990

Malaysia

Only elements are used**

Ministry of Health Drugs List, 14 May 1983

Sale of Drug Act No 368, 1952, revised 1989

Myanmar

National Drug Policy, February 1991*

Essential Drugs List, June 1989

National Drug Law, 1992

Papua New Guinea

Only elements are used**

Medical Stores Catalogue, 7th edition, 1988

Therapeutic Substances and Cosmetics Act, 1987

Sri Lanka

Elements are being used**

Essential Drugs List, 1st Ed. 1985, revised 1988.

Cosmetics, Devices and Drugs Act No. 27, 1980, Drug Regulations No. 38, 1984

Tanzania

Tanzanian National Drug Policy, 1991*

National Essential Drugs List, 1991

Pharmaceutical and Poisons Act No. 9, 1978

Tunisia

8th Final Report of Health Plan, September 1991*

National Essential Drugs List, September 1991

Several laws exist

Yemen

National Drug Policy of Yemen, April 1993*

Yemen Essential Drugs List, April 1991

Several laws and decrees exist

* A written and approved national policy covering all aspects related to drug regulatory activities exists.

** Written national drug policy does not exist as such but elements of a national drug policy are being implemented.

*** A national drug policy entitled “The Kenya National Drug Policy” was adopted in July 1994.

Drug legislation exists in all the countries except in Central African Republic where it was in the process of being developed at the time of the mission. Specific regulations relating to drug registration exist in Benin, Cameroon, Ecuador, Jamaica, Kenya, Malawi, Malaysia, Sri Lanka, Tanzania, Tunisia, and Yemen, while Malaysia, Tanzania, and Tunisia also have specific regulations relating to drug quality.

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