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Post Marketing Commitment Glossary1
Adverse event – Any untoward medical occurrence in a patient, clinical investigation subject, or consumer following administration of a medicine. The event need not necessarily have a causal relationship with the treatment or usage.
Baseline – Information gathered at the beginning of a study from which variations found in the study are measured; a known value or quantity with which an unknown is compared when measured or assessed; and/or the initial time point in a clinical trial, just before subjects begin receiving the experimental treatment being tested.
Blind – A randomized trial is "blind" if subjects and study personnel (investigators, nurses, companies) are not told which arm of the trial the patient is in. A clinical trial is "blind" if subjects and study personnel are unaware of whether they are in the experimental or control (placebo) arm of a study. Blinded studies are used to prevent bias.
Centralized Authorization Procedure (CAP) – A regulatory approval procedure within the European Union (EU). Under the centralized procedure, companies submit a single marketing authorization application to the European Medicines Agency. Once granted by the European Commission, a centralized (or 'Community') marketing authorization is valid in all European Union (EU) and EEA-EFTA states (Iceland, Liechtenstein and Norway).
Clinical trial/Clinical study – A research study to answer specific questions about vaccines, new treatments, or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine the benefit/risk profile of new medicines or treatments. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people.
Committee for Medicinal Products for Human Use (CHMP) – The CHMP is responsible for preparing the European Medicine Agency's opinions on all questions concerning medicinal products for human use and plays a vital role in the marketing procedures for medicines in the European Union: In the 'Community' or 'centralized' procedure, the CHMP is responsible for conducting the initial assessment of medicinal products for which a Community-wide marketing authorization is sought. The CHMP is also responsible for several post-authorization and maintenance activities, including the assessment of any modifications or extensions ('variations') to the existing marketing authorization.
Control group – The standard by which experimental observations are evaluated. In many clinical trials, one group of subjects will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
Dose ranging study – A clinical trial in which two or more doses of an agent (such as a medicine) are tested against each other to determine which dose works best and is least harmful.
Double-blind study – A clinical trial design in which neither the participating subjects nor the study staff knows which subjects are receiving the experimental medicine and which are receiving a placebo or another therapy.
Drug-drug interaction – A modification of the effect of a medicine when administered with another medicine. The effect may be an increase or decrease in the action of either substance, or it may be an adverse event not normally associated with either medicine.
Efficacy (of a medicine or treatment) – The ability of a medicine or treatment to produce a result. A medicine passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the procedure mandated by the FDA, Phase 2 clinical trials gauge efficacy, and Phase 3 trials confirm it.
Epidemiology – The branch of medical science that deals with the study of incidence and distribution and control of a disease in a population or sub-population. Epidemiological studies can also be designed to evaluate medicine safety.
European Medicines Agency – The European Medicines Agency is a decentralized body of the European Union (EU) with headquarters in London. 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. The European Medicines Agency is responsible for the scientific evaluation of applications for marketing authorization for medicinal products for the EU/European Economic Area (the centralized approval procedure).
Follow-up Measure (FUM) – Follow-up Measures are post-approval commitments to be submitted by the marketing authorization holder (MAH) to the European Medicines Agency and the Rapporteur within an agreed timeframe, as detailed in the Letter of Undertaking prepared by the MAH. FUMs can be required for any marketing authorization. FUMs can be requested at the CHMP opinion in relation to the initial marketing authorization application or at the CHMP assessment of any additional data/applications submitted.
Inclusion/exclusion criteria – The medical or social standards determining whether a subject may be chosen to enter a clinical trial or epidemiologic study. These criteria are based on such factors as age, gender, type and stage of disease, previous treatment history, and other medical conditions.
Independent Ethics Committees (IEC) – See Institutional Review Board
Indication – A valid reason to use a certain test, medication, procedure, or surgery. The FDA strictly regulates indications for medications available in the U.S. including the specific information under the “Indications and Usage” section of each medicine’s full U.S. Physician Prescribing Information.
Informed consent – A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate.
Institutional Review Board (IRB) – An independent committee of physicians, statisticians, researchers, community advocates, and others that ensures that a study is ethical and that the rights of study participants are protected. These are known as ethics committees or ethical review boards in the EU. All clinical trials must be approved by an IRB/Ethics Committee before they begin. Every institution that conducts or supports biomedical or behavioral research involving human participants must, by federal regulation, have an IRB that initially approves and periodically reviews the research in order to protect the rights of human participants.
Letter of Undertaking – This is a letter from the MAH in the EU which specifies the post-approval commitment including a brief description of the commitment and the anticipated date of the submission of the required data. The Letter of Undertaking must be dated and signed by the MAH (or by the person authorized for communication on behalf of the MAH).
Marketing Authorization Application (MAA) – This is an EU term and is an application to the relevant health authority within the EU, for example the European Medicines Agency, for approval to market a medicinal product.
Marketing Authorization Holder (MAH) – This is an EU term. The MAH is the company in whose name the marketing authorization has been granted. This party is responsible for all aspects of the product, including quality and compliance with the conditions of the marketing authorization.
Open-label study – A study in which doctors and participants know which medicine or vaccine is being administered.
Outcomes studies – Studies of the end results of particular health care practices and interventions, including effects that subjects experience and care about, such as change in the ability to function. For subjects with chronic conditions, where a cure is not always possible, end results may include quality of life measures, mortality (death), or morbidity (complications).
Pharmacokinetics – The processes in a living organism of absorption, distribution, metabolism, and excretion of a medicine or vaccine.
Phase of study – Studies are conducted in phases of development. Click for definitions of Phase 1, Phase 2 and Phase 3. Phase 4 refers to studies conducted after license approval, and may include post marketing commitments.
Placebo-controlled study – A method of medicine investigation in which an inactive substance (the "placebo") is given to one group of subjects, while the test medicine is given to another group. Results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition.
Post Approval Commitments (PACs) – In the EU PMCs are sometimes referred to as Post Approval Commitments.
Postmarketing Commitment (PMC) – Any study,clinical trial or other activity that an applicant has agreed, in writing, to conduct after the approval of a marketing or licensing application or further application/submission (that is not a PMR).
Postmarketing Requirement (PMR) – This is a US term. Any study, clinical trial or other activity that an applicant is required to conduct after approval of a marketing or licensing application or supplement. Studies or clinical trials may be required under PREA, the Animal Efficacy Rule, accelerated approval, and/or FDAAA.
Pregnancy registries – Surveillance studies that enroll pregnant women after they have been taking medicine and before the birth of the baby. Babies born to women taking a particular medicine are compared with babies of women not taking the medicine. Usually, evaluation of a large number of pregnancies is needed to determine the potential effect of the medicine on the babies.3
Quality of life trial – Exploration of ways to measure comfort and quality of life for individuals with chronic illnesses.
Randomization – A method based on chance by which study subjects are assigned to a treatment group. The method minimizes differences among groups by equally distributing people with particular characteristics among all trial arms.
Rapporteur/Co-Rapporteur – Members of the Committee for Human Medicinal Products (CHMP) appointed to co-ordinate the evaluation of an application for approval of a medicinal product submitted via the Centralized Authorization Procedure in the European Union (EU).
Sample size – The number of patients or experimental units required for a trial.
Side effects – Any undesired action or effect of a medicine or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental medicine must be evaluated for both immediate and long-term effects.
Single-blind study – A study in which one party, either the investigator or subject, does not know the medication being taken by the subject.
Specific Obligations (SO) – This is an EU term. Specific Obligations relate to the post-authorization phase of a medicinal product and are specific to marketing authorizations granted under exceptional circumstances (as defined in the EU legislation). Exceptional circumstances marketing authorizations are granted due to limited efficacy and/or safety data on the product being available at the time of the CHMP opinion because:
- The indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive data or;
- In the present state of scientific knowledge, comprehensive information cannot be provided or;
- It would be contrary to generally accepted principles of medical ethics to collect such information.
The fulfilment of SOs forms the basis of the annual-re-assessment that takes place at the anniversary date of the Commission Decision granting the exceptional circumstances marketing authorization.
Statistical significance – The probability that an event or difference occurred by chance alone. In clinical trials, the level of statistical significance depends on the number of subjects studied and observations made, as well as the magnitude of differences observed.
Study endpoint – A primary or secondary outcome used to judge the effectiveness or safety of a treatment.
Surveillance study – A study designed to obtain additional safety and/or efficacy data. These studies may be clinical trials or non-interventional, and are often conducted as a post marketing (Phase 4) activity.
Toxicity – An adverse event produced by a medicine that is detrimental to the subject’s health. The level of toxicity associated with a medicine varies with the condition for which the medicine is used.
Variation application – This is an EU term for an application to change an aspect of the labelling of an authorized medicinal product (i.e. the summary of product characteristics and patient information leaflet). For example a change to add a new indication for use of the product, a line extension or some new safety information.
1 Clinicaltrials.gov Glossary, .
2 Agency for Healthcare Research and Quality, .
3 U.S. FDA Guide to Pregnancy Registries, .
About the Information Posted on This Web Site:
This Web site contains information about Cheladv74’s post marketing commitments for pharmaceutical products in the US and for medicinal products approved via the CAP in the EU. The post marketing commitments listed here include pre-clinical, clinical and epidemiological studies or testing and for the EU other activities agreed to by Cheladv74 (including its group companies/subsidiaries) and the FDA or European Medicines Agency, and are used to gather additional information about the safety, efficacy, or use of approved Cheladv74 medicines, or help ensure their safe use. This Web site provides the current status of Cheladv74 post marketing commitments listed on the . It includes post marketing commitments established for Cheladv74 medicines in the US since August 1, 2000 and for EU medicinal products approved via the CAP. New post marketing commitments will be added to this Web site as they are established.
This Web site does not contain technical chemistry, manufacturing and control (CMC) commitments, or commitments for medicines for which a Cheladv74 group company is not the license holder. Information about Cheladv74's post marketing commitments is believed to be correct at the time that the information is posted, and is subject to change as progress is made in fulfilling the commitments.
This Web site is updated monthly. The status of post marketing commitments shown on the FDA Web site may differ from information displayed on this site, due to differences in the timing of updates made to the FDA Web site. The number of commitments on the two sites may also differ, due to the frequency of such updates and/or due to multiple reporting of single commitments on the FDA Web site.