The main objective of the present model system is to improve the efficiency of drug regulatory authorities, enabling them to assure that marketing authorizations are consistent with their national drug policy. This is to be achieved through the provision of technical advice, a cheap, specifically designed, locally adaptable computer system, and the necessary assistance to make effective use of it.

The introduction of desktop computers and ad hoc software alone are not enough to ensure efficient drug registration. The provision of this package and its guidelines is therefore intended as a single component of a broader national programme aimed at efficient drug registration and encompassing legislation, regulations, human resources, and appropriate facilities. Thus, before implementation of the WHO model software can take place, a feasibility study must be made to define local specifications, and to establish an appropriate organizational structure and reliable working procedures. Competent staff must be appointed, allocation of resources made, and ways to adapt the software to meet local needs should be studied.

The software programme contains the following elements:

• a file on nonproprietary names which contains over 76 000 different nonproprietary names of pharmaceutical substances (both active ingredients and excipients) in English, French, Spanish and other languages. These names include all the WHO International Nonproprietary Names (INN) as well as other widely used or nationally approved names with an indication of the approving authority, or source.

• a list of restrictive decisions taken by other regulatory authorities in relation to selected pharmaceutical substances as contained in the latest version of the UN Consolidated List of Products whose Consumption, and/or Sale have been Banned, Withdrawn, Severely Restricted or not Approved by Governments, and the monthly WHO Pharmaceutical Newsletter.

• a set of files - called catalogue files - containing codes for dosage forms, primary containers, country names, drug classification, sale/dispensing categories, etc.;

• a main register file in which consolidated information on each application and licensed product is stored.

The software package allows the user:

• to record, maintain, and retrieve information on companies, i.e. the name, mailing address, premises address, phone, fax, telex/e-mail numbers, contact/responsible officials, activity(s), operating licences and their validity, authorization to act as applicant/marketing authorization holder for drug licensing purposes, authorization to handle psychotropic/narcotic drugs,

• to record, maintain, and retrieve summary information on inspections carried out at company premises, keeping separate records for each individual activity that a company is or has been carrying out (manufacturer, wholesaler, importer, quality control laboratory, etc.),

• to record, maintain, and retrieve information on drug items for which an application and/or a marketing authorization has been received/issued, i.e. the application number, date of reception, applicant name, representative of the applicant (or other company with a role in discussing with the regulatory authority matters related to that application), drug product name, type of product (brand/generic), generic name, dosage strength, dosage form, primary container and its specifications, presentation(s), type of marketing authorization requested/issued, dispensing categories, limitations of distribution, origin, human/veterinary, linkage code with social security or other system, physical localization of the application files, shelf life & storage conditions, manufacturers involved in the different phases of production & their roles and responsible persons, ingredients & their quantities and functions, routes of administration, therapeutic classification, approved product information (indications, contraindications, etc.), internal product information (information not to be published), prices, distributors/importers, information for veterinary use, general description of the medicinal product, analytical information, regulatory situation in other countries, with up to four additional fields for user-defined information.

• to record, maintain, and retrieve status and decisions made at the different steps of the evaluation process, whereby up to twelve different types of evaluation can be used. At each step any number of substeps can be indicated to help keep track of the documentation.

• to record, maintain, and retrieve decisions such as: rejecting applications, recovering rejected applications, issuing marketing authorizations, cancelling marketing authorizations, revalidating marketing authorizations,

• to record, maintain, and retrieve variations to valid marketing authorizations, automatically retaining a history of all variations made,

• to automatically issue correspondence and certificates based on user-defined standard models, keeping a record of the issued documentation,

• to keep a record of application/marketing authorization fees and their payment,

• to carry out data searches and produce reports on the basis of multiple searching criteria encompassing all the elements of information mentioned above,

• to create, expand, maintain, and make automatic or on-line use of national data bases storing information on substances whose use is restricted, including excipients,

• to export reports and correspondence to user-selected external word processors in order to issue print outs in any format.

Alone, the package is unable to take the place of proper regulations, qualified staff, and efficient organization of work procedures. A prerequisite for advantageous use is thus to have:

• established legislation and regulations concerning company and medicinal product licensing activities with clear definitions for concepts, documents, purposes, roles of all those participating in the activities (companies, regulatory officials, external experts or individuals),

• established working procedures defining how applications should be prepared, how they are received, how they are processed according to their specificity, how they are assessed, how decisions are reached,

• sufficient qualified staff and effective links with external institutions and experts to assure sound assessment of specific technical matters.

The package is designed for use by professionals and they must be willing to work directly with a computer and receive 2-3 days training. Data entry is as concise as possible and the majority of information can be selected, thus eliminating tedious retyping of data and permitting standardization of terms. In addition, generation of correspondence and certificates is by mere selection of the document to be issued. The computer automatically places the variable information in the correct place.

The introduction of computer-assisted drug registration is a major undertaking for any drug regulatory authority. It often entails revision of the existing working procedures and habits and the establishment of new ones. For these reasons, staff at the decision-making level must be substantially involved and knowledgeable of computer-assisted drug registration. Experience has shown that the time needed to achieve optimum functioning of a system is normally two years.

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