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Magnetic Resonance Imaging
Magnetic Resonance Imaging
Malta Medicines Authority
The 10-year period after the marketing authorisation of an orphan medicine, during which similar medicines for the same indication cannot be placed on the market. Market exclusivity should not be confused with market protection or data exclusivity, market exclusivity refers only to orphan medicines.
In this period, the EMA (the Agency™) and the member states shall not accept another application for a marketing authorisation, or grant a marketing authorisation or accept an application to extend an existing marketing authorisation, for the same therapeutic indication, in respect of a similar medicinal product. This protects the original marketing authorisation holder from market competition with similar medicines with similar indications once they are approved and is intended to encourage the development of medicines for rare diseases.
The period of market exclusivity is extended by two years for medicines that also have complied with an agreed paediatric investigation plan (PIP).
Marketing authorisation (MA) refers to the approval for a medicine to be marketed.
A system of marketing authorisation was put in place to protect public health. Marketing authorisations are granted only when a competent authority (or regulatory authority™) has conducted a scientific evaluation, and is satisfied that a medicine is sufficiently safe and effective, and of high enough quality.
Different procedures exist to obtain a MA. The EMA (the Agency™) is responsible for the centralised procedure™. A single application is submitted to the EMA for evaluation by the Agency™s Scientific committees. If the assessment is positive, a single marketing authorisation is issued by the European Commission. The Marketing Authorisation Holder can then legally begin to market the medicine in all EEA (European Economic Area) countries (EU member states and the three EEA EFTA States (Iceland, Liechtenstein, and Norway).
National Competent™ Authorities (NCAs) are responsible for evaluation of marketing authorisation applications and granting MAs for medicines that fall outside the scope of the centralised procedure. Companies can apply for authorisation of these medicines in several countries simultaneously, using the decentralised procedure™. Or, once a medicine is authorised in one EU member state, a company can apply for this authorisation to be recognised in other EU countries (the mutual recognition procedure™). These procedures result in national MAs for each member state involved.
Marketing Authorisation Application
Marketing Authorisation Application
Marketing Authorisation Holder
A Marketing Authorisation Holder (MAH) is a company, firm or non-profit organisation that has been granted a marketing authorisation. The marketing authorisation allows the holder to market a specific medicinal product, in one or more EU member states. Once a medicinal product is marketed and in use by patients, the MAH continues to be responsible for monitoring safety (pharmacovigilance). Any suspected adverse reactions must be reported to the body which granted the marketing authorisation, in the form of a periodic safety update report (PSUR).
Maximum Tolerated Dose
The maximum tolerated dose (MTD) is the highest dose of a medicine or treatment that will produce the desired effect without resulting in unacceptable side effects. It is determined in clinical trials by testing increasing doses on different groups of people until the highest dose with acceptable side effects is found. Establishing the maximum tolerated dose is the main objective of Phase I clinical trials.
A medical device is an instrument, apparatus, implant, software or related article used to diagnose, prevent, or treat disease or other conditions. It must not achieve its primary intended action in or on the human body through pharmacological, immunological or metabolic means, but may be assisted in its function by such means.
Medical devices vary greatly in complexity and application. They are intended by the manufacturer to be used for:
Medical Products Agency
Medical Subject Headings
Medical Subject Headings (MeSH) is an online controlled vocabulary that lists words, groups of synonyms and related concepts, for the purpose of indexing journal articles and books in the life sciences that facilitates searching.
It was created and updated by the United States National Library of Medicine (NLM), it permits searching at various levels of specificity and allows retrieval of documents in different languages. MeSH is also used by ClinicalTrials.gov registry to classify which diseases are studied by trials registered in ClinicalTrials.gov.
Medical technology assessment
The objective evaluation of a medical technology regarding its safety and performance, its (future) impact on clinical and non-clinical patient outcomes as well as its interactive effects on economical, organizational, social, juridical and ethical aspects of healthcare. Medical technologies are assessed both in absolute terms and in comparison to other (combinations of) medical technologies, procedures, treatments or doing-nothing.
Medicines and Healthcare products Regulatory Agency
The term medicines development refers to the scientific and regulatory processes put in place in the attempt to bring a new medicine to the market. It is often used synonymously with drug development. EUPATI has chosen to use the term medicines development throughout its texts.
Medicines Evaluation Board
Medicines regulation is a system that promotes and protects public health. It applies scientific knowledge and is based on national and international laws, to prevent the use of medicines that do not work, are of poor quality, and/or that may be harmful.
Systems vary around the world but generally medicines regulation aims to:
Meta-analysis refers to methods used to compare and combine results from different, completed (reported or published), independent studies. It aims to identify patterns, to verify results, and to identify relevant relationships arising from multiple studies.
Meta-analysis can be thought of as conducting research about previous research™. In its simplest form, meta-analysis is done by identifying a common statistical measure that is shared between studies, and calculating an average of that common measure.
The reason for doing a meta-analysis is to achieve a higher statistical power, as opposed to a less precise measure calculated from a single study. In performing a meta-analysis, an investigator must make many choices which can affect the results. Such choices may include, for example, how to search for studies, how to select or exclude studies, how to deal with incomplete data, and how best to analyse the data.
The metabolome is the complete set of small molecule chemicals found in a specific cell, organ, or organism at a given time. The metabolome may include small molecule chemicals naturally produced by an organism (some sugars, vitamins, and pigments for example) as well as those not naturally produced by an organism (for example medicines, environmental contaminants, and food additives).
The metabolome can change over a period of just seconds or minutes, and changes can be caused by a huge number of things. For example, the metabolome might change as a result of changes in the organism™s environment, or after taking in food or changing activity levels.
Metabolomics is the scientific study of the metabolome.
Metastasis is the spread of tumour cells from the original site (the primary site) to another part of the body. Tumours can metastasise by invading nearby tissue, or by spreading through the circulation (blood and lymphatic system).
DNA microarray analysis is a technique that scientists use to determine whether genes are switched on or off. If a gene is switched on, it is known as gene expression. Scientists use DNA microarrays to measure the expression levels of thousands of genes at the same time. The result is known as an expression profile. This technique is used in many areas of biological and medical research. It can give valuable information about, for example, what genetic changes are responsible for tumour growth in specific individuals, or whether the expression profile of an individual makes them suitable for a specific treatment.
Microgram (Ојg) is a metric system unit of mass. A µg is equal to one millionth (1Г—10€’6) of a gram. Micrograms are typically used in a laboratory setting in early medicines development, or when measuring the concentration of a medicine in the blood.
Minimal Anticipated Biological Effect Level
The Minimal Anticipated Biological Effect Level (MABEL) is the anticipated dose needed to result in a biological effect in participants of a clinical trial. It is a safety window based on pharmacological threshold. The minimal anticipated biological effect level is recommended as a useful approach to calculate the Safe Starting Dose, as it is the lowest dose that is active.
Ministry of Health – Department of Pharmaceutical Services
Ministry of Health, Labour and Welfare
Japanese Health Ministry. http://www.mhlw.go.jp/"
Scientific misconduct is unethical behaviour or the failure to follow established guidelines (such as Good Clinical Practice) in scientific research.
Misconduct includes making things up, changing or lying about research, or copying the work of others (plagiarism). It also includes the failure to follow established guidelines where that failure is deliberate or dangerous “ researchers have a duty of care to participants in clinical trials and must take reasonable steps to protect their health and data privacy.
Scientists could be found guilty of misconduct in research if they conceal misconduct by others. The MRC's definition does not include honest error or honest differences in designing or carrying out research. Similarly, it does not include poor research unless there is 'intention to deceive'.
A biological marker, or biomarker, is something that can be measured, which points to the presence of a disease, a physiological change, response to a treatment, or a psychological condition.
A molecular biomarker is a molecule that can be used in this way for example, glucose levels are used as a biomarker in managing diabetes. Non-molecular biomarkers include medical images (for example, MRI brain images can provide information about the progression of multiple sclerosis).
Biomarkers are used in many scientific fields. They are used in different ways at different stages of medicines development, including in some cases as a surrogate endpoint to indicate and measure the effect of medicines in trials. For example, haemoglobin levels have been used in Phase III trials to support development of therapies for Type 1 Gaucher disease. This is a rare disease that affects multiple organ systems and shortens life expectancy, but it can take years to show any clinical changes. Therefore clinical changes are not a good way to evaluate the impact of new treatments for this disease, and biomarkers that show earlier changes required.
Multi-Arm Multi-Stage (MAMS) trials have a specific design that allows for several different treatments to be evaluated simultaneously against the standard treatment in a single trial.
Multiple Ascending Dose
Multiple Ascending Dose
Multiplicity occurs in clinical trials when a single clinical trial has several objectives, such as:
Multiplicity can affect statistical analyses and therefore undermine trial conclusions if it is not addressed.
Multiplicity can increase the Type I error rate. A number of statistical methods can be used to control the Type 1 error rate. The methods to be used in a clinical trial should be detailed in the study protocol or the statistical analysis plan for that trial.
Mutual recognition procedure