Essential medicines and health products

Norms, standards and guidance for pharmaceuticals

Member States rely on WHO for expertise and guidance in regulation, safety and quality assurance of medicines through development and promotion of international norms, standards, guidelines and nomenclature. The need to ensure quality medicines for HIV/AIDS, TB, and malaria in developing countries has raised additional challenges within the pharmaceutical sector, while the capacity of national regulatory authorities to interpret and apply WHO norms, standards and guidelines varies from country to country. WHO provides relevant expertise and technical assistance through such activities as guideline development, workshops and training courses, coordination and promotion of anti-counterfeiting measures, prequalification of medicines for priority diseases, pharmacovigilance for global medicine safety, regulatory and other information exchange, and review of narcotic and psychotropic substances for scheduling within the 1961 Single Convention on Narcotic Drugs and the 1971 Convention on Psychotropic Substances.

Goals

WHO is charged with the tasks of developing and maintaining global norms, international standards and guidelines for the quality, safety and efficacy of drugs, and providing guidance in harmonization efforts.

The development of norms, standards and guidelines to promote quality assurance, medicines regulation and safety of medicines is an integral part of WHO’s Constitution and a unique responsibility. It has been endorsed and supported through numerous World Health Assembly resolutions, and more recently in those on the Revised Drug Strategy.

Challenges

The increasing globalization of commerce and trade, and the merging of pharmaceutical companies, are internationalizing pharmaceutical production. International pharmaceutical norms and standards are thus more important than ever before since they serve as global tools aiming to ensure safety and quality of medicines. One of WHO’s roles is to continue to develop such international norms and standards, and to help countries implementing them.

Safety and quality of pharmaceuticals are also being promoted through regional and international efforts to harmonize drug regulation, such as those led by, ASEAN (Association of South-East Asian Nations), CAN (Andean Community), CADREAC (The Collaboration Agreement of Drug Regulatory Authorities in European Union Associated Countries), the European Union, Gulf Cooperation Council (GCC), the International Conference on Harmonisation (ICH), MERCOSUR (Southern Common Market) the Pan American Network on Drug Regulatory Harmonization (PANDRH) and the Southern African Development Community (SADC). These efforts are to be welcomed since international consensus on quality, safety and efficacy standards can speed up access to medicines.

That said, quality assurance levels differ from country to country; not all countries have the same capacity and resources for implementing agreements on drug regulation harmonization. Drug regulation experts accordingly recommend a step-wise approach for achieving the highest level of medicines safety, regulation and quality assurance in each country. WHO’s role is to identify areas in which further guidance needs to be developed for preliminary and intermediate steps. Simple screening tests for detecting substandard and counterfeit drugs are just one example.

More generally, WHO’s task is to help countries consider the implications of the relevant harmonization agreements. This is particularly true with regard to ICH, which currently does not include representatives from all developing countries. WHO needs to evaluate the impact of ICH guidelines, and advise non-ICH Member States on how to adapt existing guidelines to their own needs and conditions.

At the same time WHO must ensure that its own normative guidelines, such as its guidelines on good manufacturing practice (GMP), are maintained and updated. The GMP guidelines aim to provide globally accepted and applicable standards for ensuring that products are consistently produced and controlled according to quality standards.

Rapidly evolving science and technology are likewise creating problems for regulatory authorities everywhere. Training and specialization requirements for dealing with the ever-increasing complexity of assessing technologically advanced products can be especially burdensome. But by developing norms and standards for use in new areas of health technology and product development, WHO can reduce this problem, while at the same time helping to minimize unnecessary duplication of scientific expertise and effort.

Globalization of the pharmaceutical industry is also bringing other safety issues to the fore. For example, non-prescription medicines are becoming increasingly available to the general public in all countries, including through such channels as the Internet. Yet resources for monitoring their safety and quality are often lacking.

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