EudraLex is the collection of rules and regulations governing medicinal products in the European Union.
EudraLex is the collection of rules and regulations governing medicinal products in the European Union.
EudraLex consists of 10 volumes:
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).
The British Pharmacopoeia (BP) is the national pharmacopoeia of the United Kingdom. It is an annually published collection of quality standards for medicinal substances in the UK, which is used by individuals and organisations involved in pharmaceutical research, development, manufacture and testing.
In the European Economic Area, a supplementary protection certificate (SPC) is a sui generis intellectual property (IP) right that extends the duration of certain rights associated with a patent. It enters into force after expiry of a patent upon which it is based. This type of right is available for various regulated, biologically active agents, namely human or veterinary medicaments and plant protection products. Supplementary protection certificates were introduced to encourage innovation by compensating for the long time needed to obtain regulatory approval of these products.
A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose
Under European Union (EU) law, the qualified person (QP) is responsible for certifying that each batch of a medicinal product meets all required provisions when released from a manufacturing facility within the EU, or imported into the EU. Such provisions include that the batch was manufactured under appropriate standards, and that it passed all required testing.
Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.
In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health through non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.
The European Pharmacopoeia is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them. It is a published collection of monographs which describe both the individual and general quality standards for ingredients, dosage forms, and methods of analysis for medicines. These standards apply to medicines for both human and veterinary use.
Directive 65/65/EEC1 was the first European pharmaceutical directive.
Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products. This directive of the European Union sought to bring the benefits of innovative pharmaceuticals to patients across Europe by introducing the mutual recognition, by Member States, of their respective national marketing authorisations.
Directive 75/319/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products. This directive of the European Union sought to bring the benefits of innovative pharmaceuticals to patients across Europe by introducing the mutual recognition, by Member States, of their respective national marketing authorisations.
Council of the European Communities Directive 93/41/EEC of 14 June 1993 repealed Directive 87/22/EEC on the approximation of national measures relating to the marketing of high-technology medicinal products, as this directive had been superseded by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (5) and by Council Directive 88/182/EEC of 22 March 1988 amending Directive 83/189/EEC laying down a procedure for the provision of information in the field of technical standards and regulations (6).
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relates to medicinal products for human use in mainly countries that are part of the European Union. The Directive dealt with the disparities between certain national provisions, in particular between provisions relating to medicinal products, which directly affected the functioning of the internal market of the European Union.
The Clinical Trials Directive is a European Union directive that aimed at facilitating the internal market in medicinal products within the European Union, while at the same time maintaining an appropriate level of protection for public health. It seeks to simplify and harmonise the administrative provisions governing clinical trials in the European Community, by establishing a clear, transparent procedure.
The Good Clinical Practice Directive lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
The following outline is provided as an overview of and topical guide to clinical research:
The Trade Control and Expert System (TRACES), is a web-based veterinarian certification tool used by the European Union for controlling the import and export of live animals and animal products within and without its borders. Its network falls under the responsibility of the European Commission. TRACES constitutes a key element of how the European Union facilitates trade and improves health protection for the consumer, as laid down in the First Pillar principle. Other countries use computer networks to provide veterinary certification, but TRACES is the only supranational network working at a continental scale of 28 countries and almost 500 million people.
The European Partnership for Alternative Approaches to Animal Testing (EPAA) promotes the application of the 3Rs principles in meeting regulatory requirements for products such as pharmaceuticals, chemicals, soaps, detergents and cosmetics. The EPAA covers research and development, as well as the use of 3Rs approaches in regulatory compliance and communication and dissemination.