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
 

4.3 Infrastructure

The main infrastructures necessary for regulatory and analytical control of drugs, namely, registration, inspection, and quality control are present to a varying degree in eight countries visited: Cameroon, Ecuador, Jamaica, Kenya, Malaysia, Sri Lanka, Tunisia and Yemen (Table 3). The remaining seven countries are deficient in one or more of the above structures. All the countries have infrastructure for public and private sector drug procurement/import. In Tunisia, however, importation of drugs is a state monopoly. Two countries, Central African Republic and Papua New Guinea, have no drug regulatory authorities to control the quality of drugs, but both countries import drugs through the public and private sector.

Table 3. Existence of infrastructure for drug regulation, procurement and quality control

Country

Regulatory body

Registration unit

Public procurement sector

Private procurement sector

Quality control laboratory

Inspection service

Benin

YES

YES

YES

YES

NO

YES

Cameroon

YES

YES

YES

YES

YES

YES

Central Arican Rep.

NO

NO

YES

YES

NO

YES

Ecuador

YES

YES

YES

YES

YES

YES

Fiji

YES

NO

YES

YES

YES

NO

Jamaica

YES

YES

YES

YES

YES

YES

Kenya

YES

YES

YES

YES

YES

YES

Malawi

YES

NO*

YES

YES

NO*

NO*

Malaysia

YES

YES

YES

YES

YES

YES

Myanmar

YES

YES

YES

YES

YES

NA

Papua New Guinea

NO

NO

YES

YES

YES

NA

Sri Lanka

YES

YES

YES

YES

YES

YES

Tanzania

YES

NO

YES

YES

YES

NO

Tunisia

YES

YES

YES

YES**

YES

YES

Yemen

YES

YES

YES

YES

YES

YES

Data extracted from the country reports by the missions.
NA = Data not available
* Started operation after the assessment.
** State owned private sector.

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