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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.
Pharmacovigilance, also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilare. As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
The presence of the logo on commercial products indicates that the manufacturer or importer affirms the goods' conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certification mark. The CE marking is required for goods sold in the European Economic Area (EEA); goods sold elsewhere may also carry the mark.
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).
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.
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.
The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, reported, and archived. These principles apply to the non-clinical safety testing of substances found in various products to ensure the quality and integrity of the safety data submitted to regulatory authorities globally.
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.
An online pharmacy, internet pharmacy, or mail-order pharmacy is a pharmacy that operates over the Internet and sends orders to customers through mail, shipping companies, or online pharmacy web portal.
EudraLex is the collection of rules and regulations governing medicinal products in 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 European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia.
Pharmacy in China involves the activities engaged in the preparation, standardization and dispensing of drugs, and its scope includes the cultivation of plants that are used as drugs, the synthesis of chemical compounds of medicinal value, and the analysis of medicinal agents. Pharmacists in China are responsible for the preparation of the dosage forms of drugs, such as tablets, capsules, and sterile solutions for injection. They compound physicians', dentists', and veterinarians' prescriptions for drugs. Pharmacological activities are also closely related to pharmacy in China.
A counterfeit medication or a counterfeit drug is a medication or pharmaceutical item which is produced and sold with the intent to deceptively represent its origin, authenticity, or effectiveness. A counterfeit drug may contain inappropriate quantities of active ingredients, or none, may be improperly processed within the body, may contain ingredients that are not on the label, or may be supplied with inaccurate or fake packaging and labeling. Counterfeit drugs are related to pharma fraud. Drug manufacturers and distributors are increasingly investing in countermeasures, such as traceability and authentication technologies, to try to minimise the impact of counterfeit drugs. Antibiotics with insufficient quantities of an active ingredient add to the problem of antibiotic resistance.
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 online distribution of counterfeit medicines has been growing during the last decades. The role of Internet as an unregulated medicine market is the main reasons behind this phenomenon, especially the effectiveness of "spam" as a tool for advertising and promoting these products. Websites and social media are new powerful instruments that organized criminal groups could exploit to conduct their illicit businesses. The spread of this emerging threat worldwide poses a very high risk for the health and safety of unaware consumers.
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).
Drug disposal is the discarding of drugs. Individuals commonly dispose of unused drugs that remain after the end of medical treatment. Health care organizations dispose of drugs on a larger scale for a range of reasons, including having leftover drugs after treating patients and discarding of expired drugs. Failure to properly dispose of drugs creates opportunities for others to take them inappropriately. Inappropriate disposal of drugs can also cause drug pollution.
The distribution of medications has special drug safety and security considerations. Some drugs require cold chain management in their distribution.
The European Medicines Verification Organisation was established by the European Commission to administer the Falsified Medicines Directive in 2015. The legal basis is Regulation (EC) No. 726/2004 and Directive 2001/83/EC.
References
- ↑ "European Medicines Agency - Public health threats - Falsified medicines". www.ema.europa.eu. Retrieved 23 June 2017.
- ↑ "Understanding the Compliance Expectations for the Falsified Medicines Directive". R&D. 20 September 2018. Retrieved 21 September 2018.
- ↑ "New measures against fake medicines set to hit workload, warn GP leaders". Pulse. 19 December 2018. Retrieved 21 December 2018.
- ↑ "Almost 1,500 pharma firms could miss FMD deadline, warns body in charge". Pharmaceutical Journal. 10 August 2018. Archived from the original on 21 September 2018. Retrieved 21 September 2018.
- ↑ "Bolton pharmacy claims to be first in UK to become FMD compliant". Pharmaceutical Journal. 6 December 2018. Retrieved 20 January 2019.
- ↑ "HOLOGRAMS JUST THE MEDICINE FOR PHARMA PROTECTION IN POST EU LANDSCAPE". Pharmiweb. 15 March 2021. Retrieved 21 March 2021.