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
Fermer ce répertoire4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES
Afficher le document4.1 Pharmaceutical Import and Consumption
Afficher le document4.2 National Drug Policy and Essential Drugs List
Afficher le document4.3 Infrastructure
Afficher le document4.4 Functioning of Bodies Responsible for Regulation, Procurement and Quality Assurance
Afficher le document4.5 Operation of the WHO Certification Scheme
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
 

4.5 Operation of the WHO Certification Scheme

All 15 countries assessed are signatories to the WHO Certification Scheme and the last date of acceptance was 1986.

4.5.1 Use of the Scheme in Drug Registration

A drug regulatory agency has as one of its activities the compilation of a list (a register) of pharmaceutical products that are approved for use on the domestic market. Products that are placed on the list are licensed to individual manufacturers after they have made a suitable application to the regulatory agency. In an importing country the decisions of the drug regulatory agency have to be based to a large extent on information which it receives from the applicant. In the case of imported products, the information supplied by applicants comes from abroad (either directly or through a trade representative) and should be validated by documentary evidence, which is usually done by requesting various certificates.

The survey showed that the receipt of a Certificate of a Pharmaceutical Product as recommended by WHO is a prerequisite for drug registration in only Malaysia and Myanmar (Table 4). Out of the remaining 13 countries, eight request one or two of the following national certificates: Free Sale certificate, GMP certificate and Batch certificate. The requirement for a Certificate of a Pharmaceutical Product and other certificates is laid down in registration guidelines. Five countries do not request any kind of certificate since they do not have a drug registration programme.

The study also showed that there is an extensive use by most countries of Free Sale certificates. In Sri Lanka and Yemen, GMP certificates are requested in addition to Free Sale certificates to give additional assurance of product quality.

Review of the batch certificates received by the countries visited showed that most of the certificates obtained do not refer to the Certificate of a Pharmaceutical Product as recommended by WHO. There is also confusion concerning the nature of a WHO-type batch certificate, and of the difference from an analytical batch certificate.

4.5.2 Use of the Scheme in Procurement

Information gathered during the missions shows that a Certificate of a Pharmaceutical Product is laid down as a prerequisite in procurement guidelines of four countries: Fiji, Malaysia, Myanmar and Papua New Guinea. The rest of the countries demand one or more of the following: GMP Certificate, Batch Certificate, Free Sale Certificate, Certificate of Analysis, Certificate of Origin (Table 6).

Two countries, Fiji and Papua New Guinea used a Certificate of a Pharmaceutical Product in a restricted manner when the supplier of the product was not previously known to the procuring agency. The requirement is waived in respect of well established international pharmaceutical manufacturers.

The information received also shows that a Certificate of a Pharmaceutical Product was received for 15% of the products for Fiji and 3% of the products for Papua New Guinea included in the 1992 tenders.

In Myanmar only registered drugs are procured for the public sector. In 1992, 84% of the products procured in the public sector had a Certificate of a Pharmaceutical Product.

The above findings indicate that the Scheme is being used as recommended by WHO by only four countries in the procurement of drugs for the public sector. The remaining 11 countries use other certificates issued by exporting countries to assure the quality of drugs they procure.

The study also showed that WHO-type certificates (Certificate of a Pharmaceutical Product and Batch Certificate) supplied to drug registration authorities in importing countries were consulted by public sector procurement agencies in only one country; an indication of lack of linkage between procurement and drug regulatory authorities.

In the private sector, the level of drug quality control is less demanding than for the public procurement in the countries visited. A Certificate of a Pharmaceutical Product is requested in the private sector only by Malaysia. Benin, Ecuador, Jamaica, Kenya, Sri Lanka, Tunisia and Yemen request one or more of the following certificates: Batch Certificate, Free Sale Certificate and GMP Certificate.

Table 6. Certificates requested in public and private sector drug procurement

Name of country

Public sector certificates requested

Private sector certificates requested

Benin

Certificate of analysis from manufacturers

Certificate of authorization of sale in the country of origin

Cameroon

Certificate of analysis

No

Central African Republic

No

No

Ecuador

Free Sale

Free Sale

Fiji

Product Certificate and Batch Certificates

No

Jamaica

Free Sale and Batch Certificate

Free Sale and Batch Certificate*

Kenya

Evidence of registration in the country of origin

Free Sale Certificate

Malawi

Certificate of analysis

NA

Malaysia

Free Sale and GMP Certificates or Certificate of a Pharmaceutical Product

Free Sale and GMP Certificate or Certificate of a Pharmaceutical Product

Myanmar

Product Certificate

No

Papua New Guinea

Product Certificate and Batch Certificate

No

Sri Lanka

Free Sale and Batch Certificate

Free Sale and Batch Certificate

Tanzania

GMP and Quality Control Certificate

No

Tunisia

Free Sale and Batch Certificate

Free Sale and Batch Certificate

Yemen

Certificate of origin and Certificate of analysis

Free Sale and GMP Certificate

Data extracted from the country reports of the missions.
NA = Data not available
* Certificate of a Pharmaceutical Product is routinely requested after the assessment.

 

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