Document complet  |  Dérouler chapitre  |  Etendre sommaire  |  Version HTML imprimable
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
 

8. CONCLUSIONS

WHO Member States adopted the WHO Certification Scheme in 1975 as an instrument to assure the quality of pharmaceutical products moving in international commerce. In spite of its existence for the last 20 years, its use has not been encouraging. Drug regulatory authorities of importing countries lacked appropriate information on the mode of operation of the Scheme and its advantages and limitations when compared to other certificates.

Even though the Scheme has certain limitations and there is the problem of relying on the good faith of exporting countries, it will allow importing countries to receive formal assurance from the regulatory authorities of the exporting countries about the registration status and the quality of the pharmaceutical product they import. Importing countries, therefore, have to make maximum use of the Scheme as recommended by WHO and endeavour to establish their own effectively operational quality assurance system, including drug registration, inspection and quality control laboratory.

Because the Scheme is a non obligatory agreement left open to participation by Member States on a voluntary basis, some exporting countries are not yet party to the Scheme. Others which are committed to the implementation of the Scheme have failed to meet its requirements by not issuing a Certificate of a Pharmaceutical Product for products they export and by not subjecting export products to control measures.

While revision of the Scheme from time to time is essential, it may not serve as a means to promote its implementation. There is, therefore, a need for more concerted international public pressure and better structured informational programmes to increase the commitment of Member States and to promote better implementation of the Scheme. To achieve this it is recommended that:

Importing countries

• ensure that they have an effectively operational drug regulatory system based on legislation, regulations, established procedures and guidelines, and make the WHO Certification Scheme a requirement in drug registration and procurement;

• familiarize registration and procurement personnel with the WHO Certification Scheme through orientation and training programmes;

• maintain a good level of contact with their counterparts in exporting countries so that inadequacies in the quality of drugs can be recognized and tackled by all parties.

Exporting countries

• standardize the text of their certificates in accordance with the WHO Certification Scheme and issue a Certificate of a Pharmaceutical Product when requested by importing countries;

• subject pharmaceutical products for export to the same standards of control applied to locally consumed products;

• educate their manufacturers in the purpose and operation of the WHO Certification Scheme and ensure that batch certificates issued by manufacturers make reference to the relevant Certificate of a Pharmaceutical Product issued by the regulatory authority;

• maintain contact with the appropriate regulatory authorities in importing countries to explain and confirm the details of the WHO Certification Scheme.

The World Health Organization

• assist developing countries in their efforts to develop their own drug quality assurance systems;

• initiate informational and promotional programmes for Member States to promote global implementation of the Scheme. The programme should include regional workshops and seminars that involve representatives from regulatory authorities of both importing and exporting countries;

• initiate selected studies on pharmaceutical product flows in the international market as a background for proposals on the use of the Scheme in situations where products are re-exported;

• assess the operation of the Scheme from time to time to evaluate to what extent countries are using it.

vers la section précédente
vers la section suivante
 
 
Le Portail d'information - Médicaments essentiels et produits de santé a été conçu et est maintenu par l'ONG Human Info. Dernière mise à jour: le 1 décembre 2019