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The work involved in regulatory affairs tackles all aspects of pharmaceutical development process of medicinal products and the various regulations governing them in a given country. These include pharmaceutical laws, guidelines covering quality, safety and efficacy as well as health authorities’ attitudes and requirements. With a large amount of data filling needed in the process, standard jargon, acronyms and abbreviations have been well established and are used regularly in all forms of communications. Below are some of the basic and common abbreviations and acronyms used in regulatory affairs.
| A | |
| Ack | acknowledgement; usually an electronic acknowledgment of a successful submission |
| ADR | adverse drug reaction; unintentional and harmful response to a medicine |
| AE | adverse event; an unfortunate medical incident after exposure to a medicine but is not necessarily because of that medicine (Source) |
| AEMPS | Agencia Española de Medicamentos y Productos Sanitarios (Spanish Medicines and Healthcare Products Agency); the competent authority that oversees the quality, safety, and efficacy of pharmaceuticals and medical devices in Spain (website) |
| AF | application form; module 1.2 of the EU CTD. See eAF below (website) |
| AGES | Austrian Agency for Health and Food Safety; provide professional and independent scientific expertise related to public health, animal health, food safety, medical and drug safety, food security and consumer protection in Austria (Website) |
| AIFA | Agenzia Italiana del Farmaco (Italian Medicines Agency); is the national competent authority responsible for drugs regulation in Italy (Website) |
| ANSM | Agence nationale de sécurité du médicament et des produits de santé (French Medicines Agency); the competent authority that oversees the quality, safety, and efficacy of pharmaceuticals and medical devices in France (Website) |
| AOB | any other business |
| API | Active pharmaceutical ingredient |
| App | application |
| AR | adverse reaction; see ADR |
| AR | assessment report |
| ASMF | Active Substance Master File; see also DMF |
| ASR | annual safety report |
| ATC | Anatomical Therapeutic Chemical; a unique code assigned to a medicine according to the organ or system it works on and how it works. The classification system is maintained by the World Health Organization. (website) |
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| B | |
| BA | Bioavailability; defined as the extent to which an active ingredient in a medicine is absorbed by the body. (Source) |
| BE | bioequivalence; is when two medicines release the same active ingredient into the body at the same rate and to the same extent under similar conditions (Source) |
| also Belgium | |
| BfArM | Bundesinstitut für Arzneimittel und Medisinprodukte (Federal Institute for Drugs and Medical Devices in Germany); is the competent authority in Germany that operates under the Federal Ministry of Health. (Website) |
| BNF | British National Formulary; is a UK pharmaceutical reference book that contains a wide spectrum of information and advice on prescribing and pharmacology, along with specific facts and details about many medicines available on the UK National Health Service. (website) |
| BOS | break-out session; happens during a DCP/MRP/CP |
| BP | British Pharmacopoeia; is the national pharmacopoeia of the United Kingdom. It is an annual published collection of quality standards for UK medicinal substances. It is used by individuals and organisations involved in pharmaceutical research, development, manufacturing and testing. (website) |
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| C | |
| CA | competent authority; a medicines regulatory authority in the European Union (Source) |
| CAPA | Corrective Action Preventative Action; are improvements to an organisation’s processes taken to eliminate causes of non-conformities or other undesirable situations. |
| CCDS | company core data sheet |
| CCSI | company core safety information |
| CE | Conformité European (CE mark) |
| CEP | Certification of suitability to the Monographs of the European Pharmacopoeia The manufacturer of a substance will be able to provide proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia by means of a certificate of suitability granted by the Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM). This Certificate can be used in place of the entire module 3.2.s in the EU CTD. (website) Also Central Enquiry Point |
| CESP | Common European Submission Platform;The purpose of the system is to:
(website) |
| CHMP | Committee for Medicinal Products for Human Use; responsible for preparing the Agency’s opinions on questions concerning human medicine (Source) |
| CIOMS | Council for International Organisations of Medical Sciences; is an international nongovernmental organsation established jointly by WHO and UNESCO in 1949 to serve the scientific interests of the international biomedical community in general and promulgate guidelines for the ethical conduct of research, among other activities. (website) |
| CMDh | Co-ordination group for Mutual recognition and Decentralised procedures – Human; responsible for the examination and coordination of questions relating to the marketing authorisation of human medicines in two or more Member States in accordance with the mutual recognition or decentralised procedure (website) |
| CMDv | Co-ordination group for Mutual recognition and Decentralised procedures – Veterinary; responsible for the examination and coordination of questions relating to the marketing authorisation of veterinary medicines in two or more Member States in accordance with the mutual recognition or decentralised procedure (website) |
| CMS | concerned Member State; a European Economic Area country in which an application has been submitted for authorisation of the medicine through the mutual recognition or decentralised procedure (Source) |
| CO | clinical overview; module 2.5 of the CTD |
| COMP | Committee on Orphan Medicinal Products; responsible for reviewing applications for orphan designation for medicines that are intended for the diagnosis, prevention or treatment of rare diseases (Source) |
| corresp | correspondence |
| CP | centralised procedure; European Union-wide procedure for the authorisation of medicines, where there is a single application, evaluation and authorisation throughout the European Union. (Source) |
| CPD | continuing professional development |
| CRF | case reporting form |
| CRO | contract research organisation |
| CS | clinical summary; module 2.7 of the CTD |
| CTA | clinical trial application |
| CTD | common technical document/clinical trials directive |
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| D | |
| DCP | decentralised procedure; the procedure for authorising medicines in more than one European Union Member State in parallel (Source) |
| DDD | defined daily dose |
| derm | dermal |
| devt | development |
| DHCP | Dear Healthcare Professional |
| DIBD | development international birth date |
| Dir | Directive; EU legislation that needs to be transposed into national legislation (e.g. Directive 2001/83/EC, as amended) |
| DLP | data lock point |
| DMF | drug master file; see also ASMF |
| DOB | date of birth |
| drps | drops |
| DTD | document type definition |
| DSUR | development update safety report |
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| E | |
| eAF | electronic application form; module 1.2 of the EU CTD. Managed by the EMA and updated regularly. (website) |
| EC | Ethics Committee; (EU) is an independent body in a member state of the European Union, consisting of healthcare professionals and non-medical members, whose responsibility is to protect the rights, safety and well-being of human subjects involved in a clinical trial and to provide public assurance of that protection, by, among other things, expressing an opinion on the clinical trial protocol, the suitability of the investigators involved in the trial and the adequacy of facilities, and on the methods and documents to be used to inform trial subjects and obtain their informed consent. (Source) |
| eCRF | electronic case reporting form |
| eCTD | electronic common technical document; an interface used by applicants of marketing authorisation for medical products to submit regulatory affairs document to the agency concerned. (website) |
| EDQM | European Directorate for the Quality of Medicines & Healthcare; a Directorate of the Council of Europe, committed to achieving harmonisation of the quality standards for safe medicines throughout the European continent and beyond (website) |
| EEA | European Economic Area; is an area of free trade and free movement of peoples comprising the member states of the European Union, in addition to Norway, Iceland and Liechtenstein. (website) |
| EMA | European Medicines Agency; the main agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU (website) |
| EOP | end of procedure |
| EP | European Pharmacopeia; a published collection of monographs which describe both the individual and general quality standards for ingredients, dosage forms, and methods of analysis for medicines (website) |
| ERA | environmental risk assessment; module 1.6 of the EU CTD |
| Esub | electronic submission (website) |
| EudraVigilance | European Union Drug Regulating Authorities Pharmacovigilance; a data processing management system for reporting and evaluating suspected adverse drug reactions (ADRs) during the development and post marketing authorisation approval of medicinal products for human use in the European Economic Area (EEA) (website) |
| EURD | EU reference dates |
| EVMPD | EudraVigilance Medicinal Product Dictionary; European Medicine Agency’s pharmacovigilance system (website) |
| EWG | expert working group |
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| F | |
| FAMHP | Federal Agency for Medicines and Health Products (of Belgium); responsible for the approval and registration of new medications in Belgium and for pharmacovigilance (Website) |
| FAQ | frequently asked question |
| FDA | Food and Drug Administration; Regulatory agency of the USA (website) |
| FIMEA | Finnish Medicines Agency; is the national authority responsible for drugs regulation in Finland (Website) |
| FU | follow up |
| FUM | follow up measures |
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| G | |
| GCP | good clinical practice; A code of international standards concerning the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials. (Source) |
| GLP | good laboratory practice; a code standard concerning the testing of medicines in laboratories during their development (Source) |
| GMO | genetically modified organism |
| GMP | good manufacturing practice; a code standard concerning the manufacturing, processing, packing, release and holding of medicines (Source) |
| GSL | general sales list |
| GVP | good pharmacovigilance practices; a set of measures created to gauge the performance of the safety monitoring of medicines in the EU (Source) |
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| H | |
| HA | health authority |
| HCP | healthcare professional |
| HMA | Heads of Medicines Agencies; the network of heads of the regulatory authorities responsible for the regulation of human and veterinary medicines in the EEA (website) |
| HPLC | high performance liquid chromatography ; is a technique in analytical chemistry used to separate, identify, and quantify each component in a mixture. |
| HPRA | Health Product Regulatory Authority; formerly known as Irish Medicine Board, and is responsible in protecting and enhancing public and animal health by regulating medicines, medical devices and other health products including cosmetics. (Website) |
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| I | |
| IB | investigational brochure |
| ICH | International Council on Harmonisation; bring together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. (Website) |
| ICSRs | individual case safety reports; A document providing information related to an individual case of a suspected side effect due to a medicine. (Source) |
| IDMP | identification of medicinal products; The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standarizaton (ISO) for the identification of medicinal products (IDMP). (website) |
| IMA | Icelandic Medicines Agency; is an independent regulatory authority responsible in issuing marketing authorisations for medicines in Iceland in collaboration with regulatory authorities in the European Economic Area (EEA), ensuring control and surveillance of the pharmaceutical industry in Iceland and providing unbiased information on medicines to health professionals and consumers professional (Website) |
| IMP | investigational medicinal products; a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form” (Source) |
| IMPD | Investigational Medicinal Product Dossier; is one of several pieces of Investigational Medicinal Product (IMP) related data required whenever the performance of a clinical trial is intended in one or more European Union Member States. (Source) |
| infus | infusion |
| inh | inhalation |
| inj | injection |
| INN | international non-proprietary names; identify pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognised and is public property, also known as a generic name (Source) |
| IR | implementing regulation |
| ISO | International Organisation for Standardisation; is an international standard-setting body composed of representatives from various national standards organisations. (Website) |
| IVO | Ivowen |
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| L | |
| LOA | letter of authorisation |
| LoOI | list of outstanding issues; a set of questions addressed to a company during a procedure, such as the evaluation of a marketing authorisation application. Lists of outstanding issues are prepared after a company has already responded to a list of questions (Source) |
| LoQ | list of outstanding questions; set of questions addressed to a company during a procedure, such as a marketing authorisation application. Source) |
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| M | |
| MA | marketing authorisation; the approval to market a medicine in one, several or all European Union Member States (Source) |
| MAA | marketing authorisation application; application made to a European regulatory authority for approval to market a medicine within the European Union (Source) |
| MAH | marketing authorisation holder; company or other legal entity that has the authorisation to market a medicine in one, several or all European Union Member States (Source) |
| manuf | manufacture/manufacturer |
| MAT | marketing authorisation transfer |
| MDA | medical device alert |
| MDN | message disposition notification |
| MEB | Medicines Evaluation Board (Netherlands Medicines Agency); an independent authority that regulates the quality, efficacy and safety of medicines, and encourages better use of medicines for the right patient (Website) |
| MedDRA | Medical Dictionary for Regulatory Activities; is a clinically validated international medical terminology dictionary (and thesaurus) used by regulatory authorities in the pharmaceutical industry during the regulatory process, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation. In addition, it is the adverse event classification dictionary endorsed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (Source) |
| MeSH | Medical Subject Heading; is a comprehensive controlled vocabulary for the purpose of indexing journal articles and books in the life sciences; it serves as a thesaurus that facilitates searching and was created and updated by the United States National Library of Medicine (NLM), it is used by the MEDLINE/PubMed article database and by NLM’s catalog of book holdings. (Source) |
| MHRA | Medicines and Healthcare products Regulatory Agency ; is an executive agency of the Department of Health in the United Kingdom which is responsible for ensuring that medicines and medical devices meet applicable standards of safety, quality and efficacy (Website) |
| MRP | mutual recognition procedure; a procedure through which an authorisation of a medicine in one European Union Member State is recognised by another Member State (Source) |
| MS | Member State |
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| N | |
| NAT | National |
| NCA | National Competent Authority; a medicines regulatory authority in a European Union Member State (Source) |
| NCBI | National Centre for Biotechnology Information; houses a series of databases relevant to biotechnology and biomedicine and is an important resource for bioinformatics tools and services. Major databases include GenBank for DNA sequences and PubMed, a bibliographic database for the biomedical literature (Source) Website |
| NCO | non clinical overview; module 2.4 of the CTD |
| NCS | non clinical summary; module 2.6 of the CTD |
| NeeS | Non-eCTD electronic Submissions |
| NfG | note for guidance |
| NLM | National Library of Medicines; the world’s largest biomedical library that maintains and makes available a vast print collection and produces electronic information resources on a wide range of topics that are searched billions of times each year by millions of people around the globe. It also supports and conducts research, development, and training in biomedical informatics and health information technology. (Website) |
| no. | number |
| NOMA | The Norwegian Medicines Agency; regulatory affairs agency responsible in safeguarding the public and animal by ensuring the efficacy, quality and safety of medicine (Website) |
| notif | notification |
| NSAID | non-steroidal anti-inflammatory drug |
| NtA | notice to applicants; The body of European Union legislation in the pharmaceutical sector is compiled in Volume 1 and Volume 5 of the publication “The rules governing medicinal products in the European Union” (Website) |
| NUI | non urgent information |
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| O | |
| OMS | organisations data management service |
| OTC | over the counter |
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| P | |
| P | pharmacy |
| PAR | public assessment report |
| PASS | post authorisation safety study |
| PBRERS | periodic benefit risk evaluation report |
| portable document format | |
| Pharma | pharmaceuticals |
| PI | product information/principal investigator |
| PIL | patient information leaflet |
| PIP | paediatric investigation plan; a development plan aimed at ensuring that the necessary data are obtained to support the authorisation of a medicine for children, through studies in children (Source) |
| PMID | PubMed identifier is a unique integer value, starting at 1, assigned to each PubMed record; a PMID is not the same as a PMCID which is the identifier for all works published in the free-to-access PubMed Central (Source) |
| POA | power of attorney |
| POM | prescription only medicine |
| PPI | proton pump inhibitor |
| PRAC | Pharmacovigilance Risk Assessment Committee; the European Medicines Agency’s (EMA) committee responsible for assessing and monitoring the safety of human medicines (Source) |
| prep | preparation |
| prod | product |
| PROTECT | Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium; is a collaborative European project that comprises a programme to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance (Website) |
| PSMF | Pharmacovigilance System Master File |
| PSUR | periodic safety update report; a report prepared by the marketing-authorisation holder describing the worldwide safety experience with a medicine at a defined time after its authorisation (Source) |
| PSUSA | PSUR single assessment |
| PT | preferred term |
| Also, Portugal | |
| PUMA | paediatric-use marketing authorisation |
| PV | Pharmacovigilance; science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem (Source) |
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| Q | |
| QA | quality assurance |
| QC | quality control |
| QMS | quality management system |
| QP | quality procedure/qualified person |
| QPPV | qualified person for pharmacovigilance |
| QRD | quality review of document; templates for product information, maintained by the EMA and updated regularly (website) |
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| R | |
| RA | regulatory affairs |
| RAPS | Regulatory Affairs Professionals Society; is the largest global organisation of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products (Website) |
| ref | reference |
| reqd | required/requested |
| Rev1/Rev2/Rev3 | Revision 1, 2, 3 |
| RMP | risk management plan; module 1.8.2 of the EU CTD |
| RMS | reference Member State; the European Union Member State that leads the review of an application in a mutual recognition procedure or decentralised procedure (Source) |
| also, referentials data management service | |
| RP | responsible person |
| RSI | reference safety information |
| RTQ | response to questions |
| Rx | prescription |
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| S | |
| SAE | serious adverse event |
| SAR | serious adverse reaction |
| SDEA | safety data exchange agreement; is a legal written contract ensuring that all safety data regarding a licensed product makes its way back to the marketing authorisation holder, as quickly as possible, so that they may accomplish their legal obligations to collect safety data and to submit safety reports in a timely manner |
| SmPC/SPC | summary of product characteristics; a document describing the properties and the officially approved conditions of use of a medicine (Source) |
| SMQ | Standardised MedDRA Query |
| SOC | system organ class |
| SOP | standard operating procedure |
| SPOR | substance, product, organisation and referential master data; The European Medicines Agency (EMA) is implementing the ISO IDMP standards for the identification of medicinal products in a phased programme, based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) data (website) |
| SSRI | selective serotonin reuptake inhibitor |
| std | standard |
| sub | submission |
| SUKL | Štátny ústav pre kontrolu lieciv (Slovak Republic State Institute for Drug Control)/ Czech State Institute for Drug Control; is the institution of the state authority in the field of human pharmacy and drug precursors which oversees the quality, safety, and efficacy of pharmaceuticals and medical devices in Slovak Republic (Website) |
| SUSAR | suspected unexpected serious adverse reaction |
| susp | suspension |
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| T | |
| TBC | to be confirmed |
| TC | teleconference |
| TOC | Table Of Contents |
| TOPRA | The Organisation for Professionals in Regulatory Affairs; is the professional membership organisation for individuals who work in healthcare regulatory affairs across Europe (Website) |
| TSE | Transmissible Spongiform Encephalopathy; also known as prion diseases, are a group of progressive, invariably fatal, conditions that affect the brain (encephalopathies) and nervous system of many animals, including humans (Source) |
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| U | |
| UDI | unique device identification |
| URPL | Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; regulatory affairs agency in Poland responsible in carrying out procedures and activities involving medicinal products for human use and veterinary medicinal products (Website) |
| USP | United States Pharmacopeia; is a pharmacopeia for the United States published annually by the United States Pharmacopeial Convention, a nonprofit organisation that owns the trademark and copyright (Website) |
| USR | urgent safety restriction |
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| V | |
| VAMF | vaccine antigen master file |
| VHP | voluntary harmonisation procedure; the organisation of coordinated assessment of clinical trials by the CTFG (Source) |
| VMD | Veterinary Medicines Directorate; is an Executive Agency of the Department for Environment, Food and Rural Affairs (Defra) seeking to protect public health, animal health, the environment and promoting animal welfare by assuring the safety, quality and efficacy of veterinary medicines in the United Kingdom (Website) |
| Vol | volume |
| VSI | variation supplementary information |
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| W | |
| WG | working group |
| WHO | World Health Organization; is a specialised agency of the United Nations that is concerned with international public health. (Website) |
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| X | |
| XEVMPD | Extended EudraVigilance Medicinal Product Dictionary |
| XEVPRM | eXtended Eudravigilance Medicinal Product Report Messages |
| XML | extensible markup language |