Pharmaceutical legislation and regulation

Countries nevertheless spell out their policy intentions in their dmg legislation, or incorporate their pharmaceutical policy into national planning documents. For example, Tunisia s national pharmaceutical policy is incorporated into its five-year economic development plan. In Malaysia, dmg legislation and regulations and a system for selection, procurement and distribution of essential dmgs all serve to describe that country s policy regarding the pharmaceutical sector. 

The procurement agency should ensure that the pharmaceutical products purchased are received and stored correctly and in compliance with applicable legislation and regulations. Products should be received and stored in in such a way that their quality and integrity is preserved, batch traceability is maintained and stock can be rotated. This module focuses on quality assurance and quality control during receipt and storage of products. 

The Ministry of Health, Labour and Welfare is the governmental body responsible for enacting legislation for pharmaceutical affairs. The regulation of clinical trials and new drug approval in Japan is based on the Pharmaceutical Affairs Law and related ordinances. The objective of the Ministry is to secure a safe medical environment through a consolidated structure of accurate reviews of pharmaceuticals and medical devices and postmarketing safety measure implementation. 

High- and medium-value products such as pharmaceuticals and foods are manufactured within a regulated environment which imposes various legislation and guidelines on manufacturers. These regulatory constraints will also influence the choice of bioseparation equipment. For example, to maintain appropriate levels of cleanliness or sterility for certain products requires specialized equipment at a premium cost. 

Pharmaceutical regulation in the United Kingdom (UIQ has, since accession in 1973 to the European Union (EU), followed the requirements of the many directives that have been agreed in this field. Most of the pharmaceutical legislation now introduced in the UK emanates from the EU. Nevertheless, some specifically national laws still apply, and many national practices and procedures which have evolved over the yeeu s are specific to the UK. This chapter is intended to provide an overview of those key national requirements which are of particular relevcince to the pharmaceutical industry. The author has had personal experience of many of the practices, procedures, and regulations discussed nevertheless the reader is advised to consult the official texts and if necessary seek specific advice in the interpretation of current requirements. 

The tests to be performed to assess both efficacy and toxicity of drugs are highly regulated in the EU, as in most countries in the world. The EU rules and regulations governing medicinal products are compiled in a ten-volume legislation called Eudralex available from the website of the EC (http //ec.europa.eu/health/ documents/eudralex/index en.htm). Specific requirements on acute and chronic systemic toxicity testing of pharmaceuticals are addressed later in this chapter. 

All interested parties, such as the national authorities, the European Commission and the EFPIA, have considered these findings and offered their solutions. These have been actively debated and discussed. The EC has now proposed comprenensive reform of the EU pharmaceutical legislation. These proposals can be accessed on the EMEA website at http //pharmacos.eudra.org/F2/review/index.htm. This involves significant amendments to Directive 2001/83/EEC (for human medicines) and Council Regulation EEC/2309/93. 

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