The growing complexity of pharmaceutical products and markets means that WHO’s leadership in quality and safety assurance is needed more than ever before. In 2000, the three pillars of WHO’s work in this area were: development of internationally recognized norms and standards; establishing and maintaining effective drug regulation; and information support for pharmaceutical regulation.
Work on norms and standards included: producing the first draft of screening tests for antimalarials and anti-TB drugs; drafting and/or review of ten new quality assurance guidelines; outlining guidance on global good trade and distribution practices; producing a guide-line on establishing a pharmacovigilance centre; and continued selection of inter-national nonproprietary names (INNs). (More than 120 new names were published as proposed and a further 150 as recommended INNs.) Also, a panel of experts of safety issues was informally established with the intention of creating a WHO Advisory Committee on Safety of Medicinal Products. In South Africa, country staff assisted with development of national guidelines for good practice in the conduct of clinical trials in human participants.
Country support for drug regulation was provided to Armenia, Cambodia, Egypt, Fiji, Georgia, Iraq, Kazakhstan, Kyrgysztan, Lebanon, the Russian Federation, Syria, Uzbekistan and Yemen. Several courses were held - for instance, on drug regulation and quality assurance in Ghana for African drug regulatory authorities, and on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce in Zimbabwe for drug analysts. Additionally, WHO and the national drug regulatory authorities of Spain and Portugal co-sponsored the Annual Conference of Ibero-American Drug Regulatory Authorities in Costa Rica.
In Bangkok, WHO ran a workshop - with assistance from Tunisia - to improve monitoring and control of drug importation for all South-East Asian regional countries. At operational level, the WHO Multicountry Working
Group on Effective Drug Regulation completed its study, covering 10 countries, of the most effective approaches to drug regulation (Box 7).
Box 7: Strategies for effective drug regulation
Fewer than one in six countries have effective drug regulation. Analysis of the WHO Multicountry Working Group on Effective Drug Regulation shows, however, that there are many strategies for promoting effective drug regulation. For example, by:
• Developing a clear sense of mission for the regulatory agency.
• Ensuring adequately comprehensive and up-to-date drug laws for all drug products and information.
• Making a single agency accountable for the overall effectiveness of drug regulation.
• Keeping the national drug regulatory agency free from all political and commercial influence.
• Applying the same regulatory standards to all drugs and pharmaceutical sectors.
• Developing appropriate standards and guidelines, using them as tools for all regulatory processes and making them available to all stakeholders.
• Systematically monitoring the regulatory process to identify problems and find solutions.
• Transforming the drug regulatory authority into a learning organization that routinely conducts self-assessment and initiates quality improvement.
• Using a number of different strategies such as prioritization and streamlining of work processes to increase efficiency of resource use.
• Ensuring that the drug regulatory authority communicates regularly with clients and acknowledges the right of citizens to accurate, appropriate information on drugs marketed in their country.
Source: Ratanawijitrasin S & Wondemagegnehu E. Multi-country Study on Effective Drug Regulation. Geneva, World Health Organization, in preparation.
Development of the capacity of drug regulatory authorities to evaluate pharmaceutical quality included promotion of GMP implementation. The WHO GMP Basic Training Modules were finalized, a GMP video and CD-ROM produced, and GMP campaign materials in all 6 UN languages distributed. National GMP workshops were organized in Cambodia, China, Cyprus (attended by both Cypriot nationals and representatives of Palestine), Myanmar, the Philippines and South Africa, and country support in GMP provided to Libya and Oman.
A workshop on harmonizing drug registration was held in South Africa for SADC drug regulators. A comprehensive joint ASEAN-WHO project - ASEAN Drug Regulatory Harmonization: A Tool to Ensure Drug Quality, Safety and Efficacy - was developed and will be launched in 2001. Additionally, GMP training was provided by Pharmakon (a Danish Collaborating Centre for drug policy and pharmacy practice) for a number of countries in Europe.
Meanwhile, WHO continued to participate as an observer in the Steering Committee of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This enabled WHO to continue to liaise between non-ICH and ICH countries. Options for the continued involvement of WHO in international harmonization activities were evaluated by a WHO independent review team. A report will be finalized in 2001.
With WHO assistance, the GCC countries, in particular, worked hard to harmonize licensing and inspection functions.
WHO also continued to provide support to drug regulatory networks including AFDRAN, CADREAC, Drugnet, EMDRAC, EMEA, and the drug regulatory net-works of ASEAN and SADC countries (Figure 2).
Figure 2: Membership of drug regulatory networks is growing, as is use of SIAMED, the WHO model system for computer-assisted drug registration
At the other end of the drug regulation spectrum, combating counterfeit drugs included awareness-raising through a technical briefing at the Fifty-third World Health Assembly, with distribution of a video, posters and brochures on the issue. Additionally, a consultation on counterfeit drugs was held in Cambodia. A survey on counterfeit drugs in Cambodia is now under way, following support to the Cambodian Government to develop a national strategy to combat counterfeit drugs. Also, national programmes to combat counterfeit drugs were launched in the Newly Independent States.
In terms of dependence-producing drugs, six psychoactive substances were assessed and a recommendation made to the UN Commission on Narcotic Drugs to place four of the drugs under international control. Other related activities included development and promotion of balanced drug control policies and guidelines to improve access to opioid analgesics.
Information support for pharmaceutical regulation was undertaken with the European Agency for the Evaluation of Medicinal Products, principally to develop use of SIAMED (the WHO model system for computer-assisted drug registration). WHO also helped Burkina Faso, Cameroon, Guinea, the Maldives, Laos, Mauritania, Mexico, Mongolia, Nepal, Papua New Guinea, South Africa, Syria, Tanzania, Tunisia and Venezuela to strengthen or initiate computer-assisted drug registration (Box 8).
Box 8: Comprehensive drug information system operational in Syria
With support from WHO, and bilateral assistance, the Directorate of Pharmaceutical Affairs and the Quality Control Laboratory of the Syrian Ministry of Health completed development of a comprehensive drug information system consisting of:
• A drug registration system - using SIAMED, the WHO model system for computer-assisted drug registration.
• The WHO Model Package for Quality Control Laboratories.
• The WHO/Syrian Drug Consumption Information System - a national drug database for drug use studies.
• The WHO/Syrian Arabization system - for translation of WHO computer packages into Arabic.
• A drug quality system - a national pharmacovigilance database.
• An inspections system - for following up inspections of manufacturing sites and pharmacies.
• The ISO 9002 system - the ISO standard system for quality control laboratories.
Nearly 3000 applications have now been entered in SIAMED, and the quality control laboratory is fully computerized and has received ISO certification. Drug consumption data are being collected and will be fed into the Drug Consumption Information System, for more accurate estimation of drug needs. Ultimately, this comprehensive drug information system will lead to increased access to safe drugs of good quality and better use of health resources.
Three more countries - Cyprus, Sri Lanka and Yugoslavia - joined the WHO Programme on International Drug Monitoring operated by the Uppsala Monitoring Centre, which collects data for generating early warning signals of potential adverse drug reactions. The 23 rd annual meeting of representatives of national centres participating in the Programme was held in Tunisia (Figure 3).
Figure 3: Sixty countries now participate in the WHO Programme on International Drug Monitoring
Additionally, two drug information projects were launched - to create a WHO Model Website for National Drug Regulatory Authorities to make drug regulatory information more transparently and more widely available, and to carry out an international comparative study on drug information (Box 9).
Box 9: Rapid, wide and cost-effective distribution of quality and safety information
In 2000 considerably more quality and safety guidance information was posted on WHO’s web-site. The following information is now available at http://www.who.int/medicines/:
International nonproprietary names (INNs) in Arabic, Chinese, English, French, Spanish and Russian, as well as Latin - now available to subscribers, currently numbering more than 200.
WHO Drug Alerts - issued on an ad hoc basis when a safety concern arises and the relevant information needs to be disseminated rapidly.
WHO Drug Information - communicating pharmaceutical information that is either developed and issued by WHO, or transmitted to WHO by research and regulatory agencies worldwide.
WHO Pharmaceuticals Newsletter - containing information on safety and efficacy of pharmaceutical products and medical devices, including regulatory decisions, and recently remodelled and improved to incorporate material from the Uppsala Monitoring Centre in Sweden (a WHO Collaborating Centre for International Drug Monitoring).