European regulatory guidance

European regulatory requirements are based on legal requirements, which are, in the pharmaceutical sector, now effected at the European level by means of Regulations (which are directly binding on the concerned parties) and Directives (which are binding on the member states to which they are addressed in terms of the effect to be achieved, but which allow a degree of freedom as to the precise method of national implementation) and in guidance (often included in... 

The text will be based on an interpretation of the legislative requirements and will include consideration of many of the available guidance documents. In addition, consideration has also been taken of published EPARs and the author s own experience of the European regulatory system (which extends over some 25 years). In case of doubt or disagreement, readers are referred to the original texts of the legislation, notes for guidance, and EPARs. 

Consequently, the environmental risk assessment (ERA) of medicinal products has to be evaluated and appropriate legislation and regulatory guidance has been issued in the European Union (EU). Recently, Directive 2001/83/EC [12], as amended by Directive 2004/27/EC [13], requires an evaluation of the potential environmental risks to be performed for every application for each active ingredi-ent/excipients from every medicinal product to be authorized. However, the... 

Furthermore, ISPE is in the process of establishing guidance on process transfer. This is the result of a collaboration with the U.S. FDA and the American Association of Pharmaceutical Scientists (AAPS), with input from European regulatory authorities and the Japanese MHLW. This technology transfer guide is designed to present a standardized process and recommends a minimum base of documentation in support of the transfer request. 

Technical Guidance Document and Water Framework Directive approaches EU member state, North American, and other international approaches) and the way in which they are implemented (e.g., mandatory pass or fail probabilistic, e.g., 95th percentiles or tiered risk assessment frameworks). Soil and water standards were considered, as were values for the protection of human health and the natural environment. The focus was on European regulatory frameworks, although expert input was sought from other jurisdictions internationally. Chemical standards for aquatic (water and sediment) and terrestrial (soil and groundwater) systems were the main focus for the meeting. This workshop built on, and included some participants from, a 1998 SETAC workshop Re-evaluation of the State of the Science for Water-Quality Criteria Development (Reiley et al. 2003). 

European GMP Directives and associated regulatory guidance have very similar expectations. Recent Inspection Findings... 

ICH. International Conference on Harmonisation. An international forum for regulatory authorities in the European Union, Japan and the United States established in 1990. The ICH has issued more than 60 documents of regulatory guidance divided into the major areas of Quality (Q), Safety (S), Efficacy (E) and Multidisciplinary (M). Many of these are relevant to this book but the most relevant is ICH E9 Statistical Principles for Clinical Trials. 

In 1995, discussions among the United States, the European Community (EC), and Japan occurred to achieve harmonization of dmg and dmg product standards and to provide guidance to the worldwide pharmaceutical industry for acceptance of global regulatory filings. The International Committee on Harmonization (ICH) has proposed initial guidelines for the estabUshment of stabihty studies. 

At this stage the guideline or recommendation embodying the scientific consensus leaves the ICH process and becomes the subject of regulatory consultation in the three parts of the world. In the European Union, it Is published as a draft Committee for Proprietary Medicinal Products (CPMP) Guideline, in the United States, it is published as a draft guidance in the Federal Register, and in Japan, it is translated and issued by MHLW, for internal and external consultation. 

---