(1999; 168 pages) [Spanish]
Appendix 2. Guidelines, documents and other regulatory instruments established by WHO to support drug regulatory authorities
Over the years WHO has issued many technical and administrative guidance documents that bear direct relevance to drug regulation, such as:
• Guiding principles for small national drug regulatory authorities (1)
• Guidelines for implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce (2)
• Guidelines on import procedures for pharmaceutical products (2)
• Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (2)
• Provisional guidelines on the inspection of pharmaceutical manufacturers (3)
• Good manufacturing practices (GMP) for pharmaceutical products (3)
• Good manufacturing practices for biological products (4)
• Guidelines for the assessment of herbal medicines (2)
• Guidelines for assuring the quality of pharmaceutical and biological products prepared by recombinant DNA technology (3)
• Guidelines for good clinical practice (GCP) for trials on pharmaceutical products (5)
• Use and protection of recommended International Nonproprietary Names for pharmaceutical substances (6, 7,10)
• Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms (2)
• Ethical criteria for medicinal drug promotion (8)
• Model List of Essential Drugs and Eighth Report of the WHO Expert Committee on the Use of Essential Drugs (9)
WHO also fosters exchange of information among drug regulatory authorities, and the following four WHO publications are particularly helpful for worldwide regulatory information. The WHO Pharmaceuticals newsletter, published monthly, contains notifications received from WHO Member States on the regulation of human and veterinary drugs and medical devices, and also provides information on the surveillance of marketed products. The quarterly WHO drug information contains a section on "Regulatory matters" dealing with individual drugs subjected to regulatory action. Another quarterly, International digest of health legislation, reproduces important regulatory texts adopted by WHO Member States and geo-political groupings such as the EU. The Essential drugs monitor reports on current developments and new publications. The Consolidated list of products whose consumption and/or sale have been banned, withdrawn, severely restricted or not approved by governments published annually by the United Nations is another good source of information. As the introduction to the 1991 Consolidated list states: "It constitutes a tool which helps Governments to keep up-to-date with regulatory decisions taken by other Governments and assists them in considering the scope for eventual regulatory action. It enables government agencies which review applications for product registration to ascertain easily restrictive regulatory decisions made in other countries. It complements and consolidates the information produced within the United Nations system, including the World Health Organization's quarterly bulletin WHO Drug Information and its Pharmaceuticals Newsletter...". Countries with developed systems of drug registration or with similar social and health-care structures can be requested to provide information as to the availability of certain drugs on their markets, and the terms and conditions subject to which such drugs are being imported, manufactured, marketed or exported.
The revised WHO Certification Scheme on the Quality of Pharmaceuticals Moving in International Commerce enables importing countries to request the following types of documents which will provide more information with regard to any product in the country of export:
- Certificate of a Pharmaceutical Product;
- Statement of Licensing Status of Pharmaceutical Product;
- Batch Certificate.
The Certificate of a Pharmaceutical Product requires the following information to be furnished by the designated regulatory authority in the country of export:
- the proprietary name (if applicable) and dosage form;
- active ingredient(s) per unit dose (together with a qualitative listing of other ingredients contained in the dosage form);
- particulars of product licence and of product licence holder (or particulars of applicant for certificate if the product is not licensed to be placed on the market for use in the country of export);
- if the product is not licensed to be placed on the market for use in the country of export, the reason why such authorization is lacking (not required/not requested/under consideration/refused);
- particulars concerning inspection of the manufacturing plant in which the dosage form is produced;
- approved product information and technical summary.
The Statement of Licensing Status, on the other hand, indicates only whether or not the products listed in the certificate are licensed to be placed on the market for use in the country of export. This Statement is essentially intended for use by importing agents who are required to screen bids made in response to international tenders.
Upon request, WHO assists countries with a standardized approach to the computerization of drug regulatory data, for example, processing marketing authorizations and maintaining product lists. Under preparation are additional software products to help in the management of information related to monitoring of imports/exports, reporting on psychotropic and narcotic drugs, and samples in a drug quality control laboratory.
1. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-first report. Geneva, World Health Organization, 1990 (WHO Technical Report Series, No. 790).
2. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fourth report. Geneva, World Health Organization, 1996 (WHO Technical Report Series, No. 863).
3. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 823).
4. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-third report. Geneva, World Health Organization, 1993 (WHO Technical Report Series, No. 834).
5. WHO Expert Committee on the Use of Essential Drugs. Sixth report. Geneva, World Health Organization, 1995 (WHO Technical Report Series, No. 850).
6. International nonproprietary names (INN) for pharmaceutical substances: lists 1-73 of proposed INN and lists 1-35 of recommended INN; cumulative list no. 9. Geneva, World Health Organization, 1996.
7. Guidelines on the use of international nonproprietary names (INN) for pharmaceutical substances. Geneva, World Health Organization, 1997 (document WHO/PHARM S/NOM 1570; available on request from Division of Drug Management and Policies, WHO, 1211 Geneva 27, Switzerland).
8. Ethical criteria for medicinal drug promotion. Geneva, World Health Organization, 1988.
9. WHO Expert Committee on the Use of Essential Drugs. Eighth report. Geneva, World Health Organization, 1998 (WHO Technical Report Series, No. 882).
10. Kopp-Kubel S. International nonproprietary names (INN) for pharmaceutical substances. Bulletin of the World Health Organization, 1995, 73(3):275-279.