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| BROMI | | Better Regulation of Medicines Initiative (a UK, MHRA initiative to reduce the regulatory burden for industry for minor changes to pharmaceutical products) |
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| CA | | Competent Authority (the body responsible in EU member state for the authorising of medicinal products) |
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| CE Mark | | The European mark of approval for medical devices |
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| CHMP | | Committee for Medicinal Products for Human Use (the body responsible for preparing the European Medicines Agency opinions on all questions concerning medicinal products for human use) |
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| CMDh | | The Coordination Group for Mutual Recognition and Decentralised Procedures - Human |
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| CMS | | Concerned Member State (one of the countries involved in a DCP or MRP) |
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| CTD | | Common Technical Document (a format prescribed for submission of data for a MAA, in use for premarketing approval of medicinal products in Europe, USA, Japan and elsewhere) |
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| DCP | | Decentralised Procedure (one of the procedures available for authorisation of a medicinal product in Europe) |
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| DMF | | Drug Master File |
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| eCTD | | Electronic Common Technical Document (specification for an electronic version of the CTD) |
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| EDQM | | European Directorate for the Quality of Medicines and Healthcare (incorporating the European Pharmacopoeia and Certificates of Suitability database) |
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| EMEA | | European Medicines Evaluation Agency |
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| EPAR | | European Public Assessment Report (information published about the products assessed by the CHMP following the granting of a Marketing Authorization by the European Commission) |
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| GHFT | | Global Harmonisation Task Force (established in 1992 to achieve greater uniformity between medical devices regulatory systems) |
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| ICH | | International Conference for Harmonisation (a procedure set up to harmonise regulatory requirements for pharmaceuticals across Europe, USA and Japan) |
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| IVDD | | In Vitro Diagnostic Devices Directive (Directive 98/79/EC) |
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| MA | | Marketing Authorisation (permission required before marketing a medicinal product in EU member states) |
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| MAA | | Marketing Authorisation Application |
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| MDD | | Medical Devices Directive (Directive 93/42/EEC which covers the placing on the market and putting into service of medical devices) |
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| MHRA | | Medicines and Healthcare Products Regulatory Agency (the Competent Authority in the UK) |
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| MRP | | Mutual Recognition Procedure (one of the procedures available for authorisation of a medicinal product in Europe) |
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| NeeS | | Non eCTD electronic submission of a Marketing Authorisation Application |
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| NIBSC | | National Institute for Biological Standards and Control |
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| PAGB | | Proprietary Association of Great Britain (the UK trade association representing manufacturers of over-the-counter medicines and food supplements) |
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| PDCO | | Paediatric Committee (responsible for assessment of Paediatric Investigation Plans or PIPs) |
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| PSUR | | Periodic Safety Update Report (submitted at defined timepoints post-authorisation to the Competent Authority for a medicinal product registered in the EU) |
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| QOS | | Quality Overall Summary ( a summary in Module 2, of the quality data included in support of a Marketing Authorisation Application for a medicinal product) |
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| RMS | | Reference Member State (the lead / coordinating country involved in a DCP or MRP) |
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| SPC or SmPC | | Summary of Product Characteristics for a medicinal product included in Module 1 of a Marketing Authorisation Application |
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| TOPRA | | The association for regulatory affairs professionals |
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| UKPAR | | United Kingdom Public Assessment Report (see EPAR) |
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