Moderators: Dr Wahlroos, Finland, and Dr A. Toumi, Tunisia

In recent decades, many countries have established national drug regulatory systems to ensure the safety, efficacy and quality of drugs. However, currently only a few WHO Member States (the industrialized countries) are said to have well-developed regulatory systems in place. In most countries, weak drug regulation is often blamed on lack of political will and inadequate legislation. Strong regulation leads to independence, competence and expertise while adequate resources will provide fully functioning infrastructures.

In order to meet their objectives of promoting and protecting public health, drug regulatory authorities need to carry out their functions effectively and efficiently based on a set of principles. The purpose of this session is to discuss selected issues that are necessary to promote good regulatory practice nationally and globally and develop recommendations. The issues to be discussed include sustainability of resources, public health issues, structure, transparency and accountability, competence in efficacy, safety, and quality, timeliness, independence, collaboration as a service provider, sharing information, harmonization, and mutual recognition.

National opportunities Dr Osamu Doi, Japan Drug regulatory authorities throughout the world share many responsibilities towards populations. The Japanese Ministry of Health and Welfare (MHW) is currently improving its own drug regulatory activities through restructuring of activities.

One of our foremost responsibilities is to review and approve registration applications, such as new drug applications (NDAs) and a priority goal is to bring Japan’s drug development up to international standards. When our new good clinical practice (GCP) came into effect one year ago, the conduct of Japanese clinical trials was considerably improved while measures to assure safety and efficacy of marketed drugs, such as adverse drug reaction (ADR) reporting, are also very important. Of course we are also responsible for supervising the manufacturing, import, and export of pharmaceuticals. To enforce good manufacturing practices (GMP), for example, is one of our principal responsibilities. At the same time, an adequate supply of necessary drugs, such as vaccines, must be secured.

Policies on the distribution of drugs, especially those policies which concern pharmacies as well as pharmacists, also fall within our jurisdiction. MHW’s present concern is how to improve the capabilities of Japanese pharmacists in this era of complex products, which often require expert handling and knowledge. Although the economic aspects of drugs are not directly regulated by most of us present here, we have to take into consideration their prices and coverage by health insurance, because this often defines their availability.

Above all, there is an increasing desire from the public for effective, safe and high-quality drugs, be they brand-name, multisource, or over-the-counter (OTC). Thus, both pre-marketing and post-marketing review and control must be speedy and adequate.

In many cases, regulatory authorities do not have enough resources. With respect to Japan, its whole administrative branch will undergo major downsizing in the year 2001, when the Ministry of Health and Welfare is to merge with the Labour Ministry, and will assume a new name. I believe that a number of representatives here face similar situations. Beyond domestic concerns, we must also consider the international context. In particular, we are required to accommodate trends in international harmonization, such as those of the ICH. Furthermore, there is a general trend towards deregulation.

Last, but not least, our decision-making process must be transparent. The information utilized and the way in which decisions are made should be open to the public as far as possible. This is a process that requires considerable resources.