Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Close this folderIntroduction
View the documentNational drug regulation
View the documentProduct assessment and registration
View the documentGood manufacturing practices and inspection
View the documentDistribution
View the documentThe international pharmacopoeia and related activities
View the documentBasic tests
View the documentLaboratory services
View the documentInternational trade in pharmaceuticals
View the documentCounterfeit products
View the documentTraining
View the documentConclusion
Open this folder and view contents1. National drug regulation
Open this folder and view contents2. Product assessment and registration
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover

International trade in pharmaceuticals

WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce

The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce was developed in response to concern raised in the World Health Assembly about import of substandard products into developing countries in the 1960s. The Certification Scheme is based on the concept of sharing of responsibilities between three partners. The pharmaceutical manufacturer in the exporting country has to produce in accordance with good manufacturing practices, the drug regulatory authority of the exporting country has to inspect the manufacturing plant to confirm that it complies with good manufacturing practices, and the drug regulatory authority of the importing country has to request from its counterpart in the exporting country information on the regulatory status of the product it intends to import and confirmation that the manufacturer complies with standards of good manufacturing practices. In normal circumstances the certified information issued by the drug regulatory authority in the exporting country, as provided for under the WHO Certification Scheme, reaches the drug regulatory authority of the importing country via the manufacturer, exporter or importer and is used as the basis for drug registration in the importing country. When there are problems or queries the Certification Scheme provides for a channel for direct communication between the regulatory authorities in the importing and exporting countries.

Some countries do not yet have effectively functioning drug registration systems. In such situations the procurement agency has to operate an unofficial de facto registration system in order to assure the quality of products it intends to purchase and makes use of the provisions of the Certification Scheme before importing a new pharmaceutical formulation. Provision of information as provided for under the Certification Scheme should be a precondition when tenders are submitted.

Where a legally based national drug registration system exists, all procurement agencies must comply with the law and limit their procurement to duly registered products. In the case of favourable conditions for a product not yet registered in the country, the procurement agency should submit all necessary information to the registration body. This may speed up the registration process for public sector procurement agencies, provided all elements necessary to guarantee quality have been properly and positively evaluated.

The Certification Scheme was first recommended by the World Health Assembly in 1969 in resolution WHA22.50. A revised version was recommended in 1975 in resolution WHA28.65. The Certification Scheme was evaluated in the 1980s and a further revised and expanded version was recommended to WHO Member States by the World Health Assembly in resolution WHA41.18 of 1988. The Scheme now includes provision of approved product information, certification of veterinary products when administered to food-producing animals, and certification of starting materials in so far as they are subject to regulatory control in the country of export. Certification of starting materials, and particularly of active pharmaceutical ingredients, has become of particular relevance as many developing countries now produce the dosage forms themselves and are therefore more concerned to import raw materials of good quality. Parallel to this, there has been a shift in the production of active drug substances to developing countries, especially the more industrially advanced ones.

A country wishing to participate in the Certification Scheme must notify WHO of its intention to do so. The country must define both the extent to which it wishes to participate and the authority competent to issue and/or receive information as provided for in the Scheme. As of 1 January 1997, 140 of the 190 WHO Member States had informed the Organization officially of their intention to participate.

In order to facilitate the use of the Certification Scheme, the World Health Assembly endorsed provisional guidelines in 1992 in resolution WHA45.29. These guidelines, which deal with certification of pharmaceutical products, were refined following field trials in a number of WHO Member States and discussion during the sixth and seventh biennial International Conferences of Drug Regulatory Authorities. The revised guidelines were adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations and published in its thirty-fourth report. Separate guidelines on certification of active pharmaceutical ingredients are under development.

Chapter 7 contains the text of the revised guidelines for implementing the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. It also reproduces Resolution WHA50.3, adopted by the World Health Assembly in May 1997, which endorses the guidelines and urges Member States to implement them. A regularly updated list of Member States participating in the Scheme can be obtained from Regulatory Support, Division of Drug Management and Policies, WHO, 1211 Geneva 27, Switzerland, together with the addresses of the competent authorities of participating countries and details of any significant reservations expressed by countries regarding their participation in the Scheme.

Import procedures

Chapter 7 also contains guidelines on import procedures for pharmaceutical products, which take into account the needs of, and resources available in, developing countries. They are intended to provide a framework for the effective control of pharmaceutical products at specified ports of entry and a basis for collaboration between the various interested parties.

Arrangements for independent analysis of drug samples

In the case of disputes arising from an unanticipated adverse reaction to a drug or from physical signs of deterioration in the product, a country may need to turn to a foreign laboratory for analytical confirmation of a presumed defect. The solution should be first sought at the regional level, through the respective WHO Regional Office. Regional or subregional testing laboratories have been or are being established in the WHO Regions of Africa, the Americas and the Eastern Mediterranean. Exceptionally, an impartial retesting in a national laboratory of a European country may be arranged through WHO in Geneva. It should be noted, however, that in this case analyses will be expensive (over US$ 300 for a full pharmacopoeial testing) and may take one or two months (or more), depending on the workload of the laboratory approached. It is hoped that these arrangements can be extended to all products covered by the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce and that, when such analyses have undisputed implications for public health, directors of the testing laboratories will have discretionary authority to undertake them at reduced cost or even free of charge.

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