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Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce - EDM Research Series No. 016
(1995; 156 pages) Voir le document au format PDF
Table des matières
Afficher le documentACKNOWLEDGMENTS
Afficher le documentPREFACE
Afficher le documentEXECUTIVE SUMMARY
Ouvrir ce répertoire et afficher son contenu1. INTRODUCTION
Afficher le document2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT
Afficher le document3. ACTIVITIES UNDERTAKEN: Preparations and Method of Work
Ouvrir ce répertoire et afficher son contenu4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES
Ouvrir ce répertoire et afficher son contenu5. ANALYSIS OF RESULTS FROM EXPORTING COUNTRIES
Afficher le document6. ANALYSIS OF RESULTS FROM INTERNATIONAL SUPPLY AGENCIES
Ouvrir ce répertoire et afficher son contenu7. SUMMARY ANALYSIS
Afficher le document8. CONCLUSIONS
Afficher le documentANNEX 1: Resolution adopted by the Twenty-second World Health Assembly
Afficher le documentANNEX 2 (a): Resolution Adopted by the Twenty-Eighth World Health Assembly
Afficher le documentANNEX 2 (b): Certificate of Pharmaceutical Product(S)1
Afficher le documentANNEX 3 (a): Resolution adopted by the Forty-first World Health Assembly
Afficher le documentANNEX 3 (b): Certificate of Pharmaceutical Product(s)1 (Proposed Layout)
Afficher le documentANNEX 4 (a): Proposed Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Afficher le documentANNEX 4 (b): Certificate of a Pharmaceutical Product
Afficher le documentANNEX 4 (c): Statement of Licensing Status of Pharmaceutical Product(s) Model Statement of Licensing Status of Pharmaceutical Product(s)
Afficher le documentANNEX 4 (d): Manufacturer’s/Official Batch Certificate of a Pharmaceutical Product
Afficher le documentANNEX 5: Protocol for the Assessment of the Use of the WHO Certification Scheme by Importing Country
Afficher le documentANNEX 6: List of Participants in the Study
Afficher le documentANNEX 7: Protocol for the Assessment of the Use of the WHO Certification Scheme by Exporting Country
Afficher le documentANNEX 8: Protocol for the Assessment of the Use of the WHO Certification Scheme in an International Supply Organization
Afficher le documentANNEX 9: Study Instrument for Assessment of the WHO Certification Scheme by Importing Country
Ouvrir ce répertoire et afficher son contenuANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme
Afficher le documentBACK COVER
 

3. ACTIVITIES UNDERTAKEN: Preparations and Method of Work

In order to realize the above objectives, an informal meeting was held in DAP from 30 September to 1 October 1992 with the participation of DAP, the Division of Drug Management and Policies (DMP), United States Food and Drug Administration (FDA) specialists, and independent experts dealing in particular with the issue of quality assurance of imported pharmaceuticals.

The meeting concluded that an assessment in selected countries of the extent of the actual application of the Scheme and of pertinent administrative practices could facilitate the promotion of the Scheme and thus improve the quality assurance of imported pharmaceuticals.

The meeting defined the general objective of the proposed multi-country study to be based on reports of missions to a number of countries. It was agreed that the study had to focus on essential drugs imported by developing countries, and on the actual use of the Certification Scheme as an instrument for the quality assurance of those products.

The selection of countries to be included in the study was based on criteria considered during the meeting. Priority was given to developing countries that were importing pharmaceuticals, had weak (or in a few cases strong) drug regulatory systems, were willing to participate in the assessment, and had need of the Certification Scheme. The following 15 countries were selected: a) from the African region: Benin, Cameroon, Central African Republic, Kenya, Malawi and Tanzania; b) from the American region: Ecuador and Jamaica; c) from the Eastern Mediterranean region: Tunisia and Yemen; d) from the South-East Asian Region: Myanmar and Sri Lanka; and e) from the Western Pacific region: Fiji, Malaysia and Papua New Guinea.

Communications were initiated with the countries by mid-December 1992 through WHO Regional Offices and WHO Representatives, informing them about the missions and requesting their concurrence with the proposal. By the end of March 1993, all 15 countries indicated above had agreed to participate in the study.

The protocol and report outline to be used by the missions were prepared jointly by DAP, DMP, and FDA, and were amended by a consultant (annex 5). Their application was further discussed during a preparatory briefing session of international team members, in Nairobi, in April 1993.

The mission teams for country visits were composed of a team leader (international), a team member (international, preferably from the region) and two local team members (annex 6). The international team members were selected from among specialists who were known to have adequate experience in pharmaceutical administration and drug supply matters.

Because of a need to obtain a global overview of the Certification Scheme operation through the project in a uniform manner, a briefing session was organized in Nairobi, Kenya from 14-16 April 1993. The participants included seven international team members and the representatives of DAP and DMP. The main discussion during the briefing pertained to the contents of the mission protocol and the ways of obtaining specific answers in the course of country visits. As a result, a number of modifications were introduced into the text of the protocol to better explain individual questions.

The involvement of national experts in the mission teams was an essential element of the project. It was considered that in this way, the study would involve professionals with appropriate access to the necessary local data, and therefore, enable much of the preliminary work to be carried out before the arrival of the international team, thus shortening the period of stay in the country.

The appointment of local mission members was carried out with the assistance of the WHO Representatives in the countries concerned. Information material consisting of a letter requesting their collaboration and a selection of background material on the WHO Certification Scheme was sent to the national experts together with the draft protocol to be used during their missions. In the 15 countries included in the project, 30 persons altogether served as local team members.

The country missions took place as follows: in the African countries, from 19 April to 7 May 1993; in countries of the American region, from 31 May to 11 June 1993; in the Eastern Mediterranean region, from 19 to 23 April and 17 to 23 July 1993; in the South-East Asian countries, from 18 to 23 May and 5 to 9 July 1993; and in the Western Pacific countries, from 24 May to 11 June 1993.

Protocols for the assessment of exporting countries and international supply organizations were prepared jointly by the staff of DAP and DMP together with a group of consultants (annexes 7 and 8). It was agreed that each mission should stay about one week (five to eight working days) in a country, but that visits to international supply organizations should be shorter.

Assessment of exporting organizations and countries took place as follows: IDA from 5-6 October 1993; UNICEF from 7-8 October 1993; France from 24-31 October 1993; and India from 14-26 February 1994. Reports submitted by mission leaders were transferred to the study instruments developed for storage and easy retrieval of data (annex 9).

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