European union medicinal regulatory authorities

The European Union drug regulatory authorities network (EudraNet) is an internetworking service provided to EU medicinal regulatory authorities in collaboration with the European Commission Directorate-General for Industry. Part of the EudraNet is accessible to industry and the general public. 

The Committee was informed by the European Medicines Agency (EMEA) of a proposed approach to facilitate inspections and to avoid duplication of inspections. A GMP database was being established in the European Union by Member States that would provide information on and outcome of inspections. The database was expected to be released in 2006. Access rights were being discussed with WHO, the Pharmaceutical Inspection Cooperation Scheme (PIC/S), the European Directorate for the Quality of Medicines (EDQM) and other organizations. Different levels of access will exist including one for public access and others for national medicine regulatory authorities, WHO and PIC/S. 

Some regulatory authorities have foreseen the future impact of TM and set up appropriate guidelines. The European Union has legislation for traditional herbal products. Another example is the Therapeutic Goods Administration of Australia, which has set up a complementary medicine section that controls the regulatory practices for TM. 

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... 

In 1996, the VICH program was officially launched among the European Union, Japan, and the United States (52). Among the objectives of the VICH is to provide a forum for a constructive dialogue between regulatory authorities and the veterinary medicinal products industry on the real and perceived differences in the technical requirements for product registration in die three jurisdictions, with tlie expectation that such a process may serve as a catalyst for a wider international harmonization. VICH should identify areas in which modifications... 

Dr. Mircheva was instrumental in the passing of the first Medicines Law of 1995 and initiated Collaboration Agreement between Drug Regulatory Authorities in European Union Associated Countries (CADREAC). She has been a visiting scientist in Germany and is a member of a number of scientific societies and on the editorial boards of scientific and regulatory journals. 

Six parties to ICH represent the regulatory bodies and research-based industry in the three regions, Europe, Japan, and the United States, where the vast majority of new medicines are currently developed. These Six Parties are directly involved in the decision making process and were selected as they represent the regulatory bodies and the research-based industry in the European Union, Japan, and the United States. However, the Conference, its preparations, and follow-up activities are conducted in an open and transparent manner and the presence of observers from other regulatory authorities and WHO is welcomed as a means of ensuring that the benefits of progress towards harmonization can be utilized worldwide. The Six Parties are as follows ... 

The European Medicines Agency (EMEA) is a decentralized body of the European Union created with the objective to harmonize regulatory activities in Europe. EMEA began its activities in 1995, when the European system for authorizing medicinal products was introduced, providing for a centralized and a mutual recognition procedure. Its main responsibility is the protection and promotion of public and animal health through the evaluation and supervision of medicines for human and veterinary use. 

In 1996 and 1997 the International Conference on Harmonization (ICH) published guidelines for analytical method validation [18]. These documents present a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of registration applications submitted within the European Union, Japan, and the United States. Regulatory agencies have emitted documents, largely inspired by ICH documents. It is the case of the FDA [19, 20], the European Medicines Agency (EMA) [21,24], and the Australian Pesticides and Veterinary Medicines Authority [25], to name just a few. 

The definitions of MD and drug (or medicinal product) differ, and the purpose of this chapter is not to give an overview of the different definitions of MD and drug adopted worldwide by various regulatory authorities. However, defining what is meant by drug and MD is useful to the subsequent discussions, so we limit ourselves to the definitions adopted by the Food and Drug Administration (FDA) and the European Union (EU). 

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