A pharmacopoeia, pharmacopeia, or pharmacopoea, in its modern technical sense, is a book containing directions for the identification of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.
A regulation is a legal act of the European Union which becomes immediately enforceable as law in all member states simultaneously. Regulations can be distinguished from directives which, at least in principle, need to be transposed into national law. Regulations can be adopted by means of a variety of legislative procedures depending on their subject matter.
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.
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 International Pharmacopoeia is a pharmacopoeia issued by the World Health Organization as a recommendation, with the aim to provide international quality specifications for pharmaceutical substances and dosage forms, together with supporting general methods of analysis, for global use. Its texts can be used or adapted by any WHO member state wishing to establish legal pharmaceutical requirements.
EudraLex is the collection of rules and regulations governing medicinal products in the European Union.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia.
The following outline is provided as an overview of and topical guide to clinical research:
A drug reference standard or pharmaceutical reference standard is a highly characterized material suitable to test the identity, strength, quality and purity of substances for pharmaceutical use and medicinal products.
Marketing authorisation is the process of reviewing and assessing the evidence to support a medicinal product, such as a drug, in relation to its marketing, finalised by granting of a licence to be sold.
The term environmental persistent pharmaceutical pollutants (EPPP) was first suggested in the nomination in 2010 of pharmaceuticals and environment as an emerging issue in a Strategic Approach to International Chemicals Management (SAICM) by the International Society of Doctors for the Environment (ISDE). The occurring problems from EPPPs are in parallel explained under environmental impact of pharmaceuticals and personal care products (PPCP). The European Union summarizes pharmaceutical residues with the potential of contamination of water and soil together with other micropollutants under "priority substances".
The Committee on Herbal Medicinal Products (HMPC), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on herbal medicines.
Drug nomenclature is the systematic naming of drugs, especially pharmaceutical drugs. In the majority of circumstances, drugs have 3 types of names: chemical names, the most important of which is the IUPAC name; generic or nonproprietary names, the most important of which are international nonproprietary names (INNs); and trade names, which are brand names. Under the INN system, generic names for drugs are constructed out of affixes and stems that classify the drugs into useful categories while keeping related names distinguishable. A marketed drug might also have a company code or compound code.
Because of the uncertain nature of various alternative therapies and the wide variety of claims different practitioners make, alternative medicine has been a source of vigorous debate, even over the definition of "alternative medicine". Dietary supplements, their ingredients, safety, and claims, are a continual source of controversy. In some cases, political issues, mainstream medicine and alternative medicine all collide, such as in cases where synthetic drugs are legal but the herbal sources of the same active chemical are banned.
Official Medicines Control Laboratory (OMCL) is the term coined in Europe for a public institute in charge of controlling the quality of medicines and, depending on the country, other similar products (for example, medical devices). They are part of or report to national competent authorities (NCAs).
Formularium Slovenicum is Slovenian addendum to the European Pharmacopoeia. It promotes Slovenian pharmaceutical terminology and the regulations affecting the field of pharmacy in Slovenia. It has been regularly published by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia.
