Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce (WHO/DAP, 1995, 156 p.): 2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT

Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce (WHO/DAP, 1995, 156 p.)

		(introductory text...)
		ACKNOWLEDGMENTS
		PREFACE
		EXECUTIVE SUMMARY
		1. INTRODUCTION
		2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT
		3. ACTIVITIES UNDERTAKEN: Preparations and Method of Work
		4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES
		5. ANALYSIS OF RESULTS FROM EXPORTING COUNTRIES
		6. ANALYSIS OF RESULTS FROM INTERNATIONAL SUPPLY AGENCIES
		7. SUMMARY ANALYSIS
		8. CONCLUSIONS
		ANNEX 1: Resolution adopted by the Twenty-second World Health Assembly
		ANNEX 2 (a): Resolution Adopted by the Twenty-Eighth World Health Assembly
		ANNEX 2 (b): Certificate of Pharmaceutical Product(S)1
		ANNEX 3 (a): Resolution adopted by the Forty-first World Health Assembly
		ANNEX 3 (b): Certificate of Pharmaceutical Product(s)1 (Proposed Layout)
		ANNEX 4 (a): Proposed Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
		ANNEX 4 (b): Certificate of a Pharmaceutical Product
		ANNEX 4 (c): Statement of Licensing Status of Pharmaceutical Product(s)
		ANNEX 4 (d): Manufacturer’s/Official Batch Certificate of a Pharmaceutical Product
		ANNEX 5: Protocol for the Assessment of the Use of the WHO Certification Scheme by Importing Country
		ANNEX 6: List of Participants in the Study
		ANNEX 7: Protocol for the Assessment of the Use of the WHO Certification Scheme by Exporting Country
		ANNEX 8: Protocol for the Assessment of the Use of the WHO Certification Scheme in an International Supply Organization
		ANNEX 9: Study Instrument for Assessment of the WHO Certification Scheme by Importing Country
		ANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme
		BACK COVER

2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT

During the last two decades WHO has promoted the use of the WHO Certification Scheme particularly by importing countries of the developing world who, for various reasons, may be vulnerable to problems associated with pharmaceutical products that do not meet specifications. These countries often do not have the national laboratories required to verify the quality of drugs.

Since the introduction of the Scheme, there have been important changes in the nature and scope of the international market in pharmaceutical products. Many more countries are now involved in the export of drugs so that there is no longer a limited number of primary sources in a few major industrial countries. In addition, the opportunities for re-packaging and labelling have grown to further complicate the issuance of a Certificate of a Pharmaceutical Product by a national regulatory authority.

It has also become clear that the exact forms of the WHO Certification Scheme, as described above, have not yet been applied to most of the pharmaceutical products moving in international trade. When this is coupled with the serious problems of sub-standard drugs moving in international commerce, particularly to developing countries, it is clearly important to assess the practical application of the Certification Scheme.

The Action Programme on Essential Drugs (DAP), with the financial support of USAID's Office of Health, therefore, decided to carry out an independent assessment of the use of the Certification Scheme in drug procurement/supply systems and current mechanisms of drug quality assurance, in order to examine its effectiveness and enhance its wider use.