Model system for computer-assisted medicines registration
The Conference of Experts on the Rational Use of Drugs held in Nairobi in November 1985 identified inadequate or ineffective drug regulation and control as a major cause of unsatisfactory drug quality and irrational drug use in many member states. The recommendations of this conference have been endorsed by different subsequent resolutions of the World Health Assembly. These resolutions require WHO to prepare guidelines for a simple drug regulatory authority (DRA), and to support governments in setting up or strengthening DRA.
In response to this, WHO has developed a Model System for Computer-assisted Drug Registration (SIAMED) in consultation with several national drug regulatory authorities.
The main objective of the WHO 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, an inexpensive, specifically designed and locally adaptable computer system, and further technical assistance as required.
SIAMED has been developed by the WHO and the Pan American Health Organization (PAHO) with technical and financial support from various partner organizations and donors. The development of the software package took place with support and technical input from many experts and users in regulatory authorities in several countries. A practical guide, "How to implement computer-assisted drug registration", has been prepared in collaboration with Management Sciences for Health.
Development of SIAMED is an ongoing process and responds to the changes taking place in the field of medicines regulatory control. A collaborative project with the European Medicines Evaluation Agency (EMEA) is to release of a customized version of SIAMED using both a modified regulatory approach reflecting the requirements of the EMEA and a different computing technology.
Checklist for Strenghtening National DRAs
How to implement computer assisted drug registration
SIAMED user manual
The development of the WHO model system has been undertaken with the realization that there are many prerequisites for introduction of computerized systems which we have highlighted in our publication listed below. Computerization can contribute to improving the regulatory information management process and information retrieval. At the same time, it's efficiency and effectiveness is dependent on the existance of efficient drug registration.
Major steps for successful implementation
- Obtain management and policy support
- Review Enabling Legislation and Regulations
- Identify Needs, Define Enabling Objectives, and Establish Priorities
- Identify Funding and Support Requirements and Sources
- Appoint Technical Coordinator and Define Time Schedule
- Review Forms, Procedures, and Correspondence
- Update Forms and Certificates, as Required
- Prepare Data and Decide How to Handle Data Entry
- Train Staff in Software System and New Procedures
- Begin Computerization
- Operate and Maintain Computer-Assisted Drug Registration System
Prior to engaging in computerization and implementation of SIAMED, WHO requires a feasibility study to define local specifications, the establishment of an appropriate organizational structure and reliable working procedures, the appointment of competent staff, allocation of resources, the adaptation of the software to meet local needs, and data entry and validation.
The provision of SIAMED (installation, training and/or initial start-up operations) and its guidelines is therefore intended as a component of a broader programme aimed at efficient drug registration and encompassing legislation, regulations, human resources, and appropriate facilities. Support, if required, can be provided by WHO for these activities, if funds permit.
The present version of SIAMED is available in FoxPro (DOS & Windows). The system can be used as a stand-alone installation or in a client-server environment as front-end and a back-end data store via OLE/ODBC.
Software and guidelines are being continually improved in close collaboration with the different partners and, where necessary and feasible, adapted to meet specific national requirements.
For minimum hardware and software requirements to run SIAMED, please refer to the user manual.
The present version permits the recording, updating, and retrieval of:
- information on companies, including short and full company name, mailing address, premises address, phone, fax, telex/e-mail numbers, contact/responsible officials, activity(ies), operating licences and their validity, authorization to act as applicant/licence holder for drug registration purposes, authorization for psychotropic/narcotic drugs.
- summary information on inspections carried out at company premises, separate records for each individual activity that a company carries out (manufacturer, wholesaler, etc.), and preparation of inspection programmes based on a variety of user-defined criteria encompassing geographical area, type of company activity, type of items (e.g. injectable forms, solid oral forms, etc.), characteristics of inspectors and degree of risk identified for each premises.
- information on medicinal products for which an application has been received or a marketing authorization issued, including application number, date of reception, applicant name, representative of the applicant (or other company with any role other than applicant, manufacturer, product-licence holder, distributor), drug product name, type of product (brand/generic), generic name, dosage strength, dosage form, primary container and its specifications, presentation(s), type of authorization requested/issued, dispensing category, limitations of distribution, origin, human/veterinary, linkage code with social security or other system, physical localization of the application files, shelf life and storage conditions, manufacturers involved in the different phases of production and their roles and responsible persons, active and inactive ingredients with their quantities and functions, routes of administration, therapeutic classification, summary of product characteristics (indications, contraindications, etc.), internal data sheet (information not to be published), prices, distributors/importers, veterinary information, general description of the drug item, analytical information, regulatory situation in other countries, and up to four additional fields for user-defined information.
- status of applications in the evaluation process. Up to twelve different paths of evaluation can be used: application for a new human/veterinary/biological drug, application for renewal of marketing authorization of a human/veterinary/biological drug, application for minor variation to marketing authorization of a human/veterinary drug, application for major variation to marketing authorization of a human/veterinary/biological drug, and any special procedure. At each step any number of sub-steps (or responsible officials/experts) can be indicated to help keep track of the documentation under evaluation.
- decisions such rejection of applications, issuance of marketing authorizations, cancellation of marketing authorizations, renewal of marketing authorizations, and variation to marketing authorizations.
- variations to valid marketing authorizations, automatically keeping history of all variations made.
The present version permits also:
- to automatically issue correspondence and certificates based on user-defined standard models with facilities for keeping a record of the issued documentation and responses to correspondence issued, managing calculation of duration of assessment of applications with deduction of time elapsed while response to correspondence was pending.
- to keep record of payments and dues regarding application and marketing authorization fees,
- to carry out data searches and produce reports on the basis of multiple searching criteria encompassing all the pieces of information mentioned above.
- to produce a wide variety of preset and user-defined reports based on all or a subset of data.
- to create, expand, keep up to date, and make automatic or on-line use of national databases storing information on active substances (e.g. restricted, banned) and excipients (admitted uses, limits, etc.).
- to export reports and correspondence to user-selected external word processors in order to issue printouts in any format.
Country support activities
Support has been provided to the following countries: Benin, Botswana, Burkina Faso, Cameroon, Central African Republic, Chad, Cuba, Dominican Republic, Egypt, Ethiopia, Guatemala, Guinea, Honduras, Jordan, Maldives, Mali, Mauritania, Mexico, Namibia, Nepal, Nicaragua, Niger, Poland, South Africa, Syria, Tanzania, Tunisia, Uganda, Venezuela.
Training workshops are part of an ongoing training plan. Local and Regioml training is delivered to participants from drug regulatory officials from countries of all WHO regions.