| AGIT | Working Group on Information Technology, Switzerland (Arbeitsgruppe Informationstechnologie) |
| ANDA | Abbreviated New Drug Application (FDA) |
| ANMAT | National Administration for Medicines, Food and Medical Technology, Argentina (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) |
| ANVISA | National Agency for Sanitary Monitoring, Brazil (Agência Nacional de Vigilância Sanitária) |
| API | Active Pharmaceutical Ingredient |
| ASEAN | Association of Southeast Asian Nations |
| BA | Bioavailability |
| BCS | Biopharmaceutics Classification System |
| BE | Bioequivalence |
| BPFK | National Pharmaceutical Control Bureau, Malaysia (Biro Pengawalan Farmaseutikal Kebangsaan) |
| CDE | Center For Drug Evaluation, Taiwan |
| CDER | Center for Drug Evaluation and Research (FDA) |
| CDSCO | Central Drugs Standard Control Organization (India) |
| CHMP | Committee for Medicinal Products for Human Use (EMA) |
| CRO | Contract Research Organization |
| CTA | Clinical Trial Application |
| CTD | Common Technical Document (ICH) |
| DCD | Drug Control Division, Thailand |
| DCP | Decentralized Procedure (EU) |
| DKMA | Danish Medicines Agency, Denmark |
| E | Efficacy (ICH) |
| eCTD | Electronic Common Technical Document (CTD) |
| EDA | Egyptian Drug Authority, Egypt |
| EDQM | European Directorate for the Quality of Medicines & HealthCare |
| EMA | European Medicines Agency (formerly European Medicines Evaluation Agency – EMEA) |
| ER | Extended Release |
| EU | European Union |
| EWP | Efficacy Working Party (EMA) |
| FDA | Food and Drug Administration, USA |
| FIM | First-In-Man (Clinical Study) |
| GCP | Good Clinical Practice(s) |
| GLP | Good Laboratory Practice(s) |
| GIF | Graphics Interchange Format |
| GMP | Good Manufacturing Practice(s) |
| HPFB | Health Products and Food Branch, Canada (of Health Canada) |
| HSA | Health Sciences Authority, Singapore |
| HVD | Highly Variable Drug |
| HVDP | Highly Variable Drug Product |
| ICH | International Conference on Harmonization (Technical Requirements for the Registration of Pharmaceuticals for Human Use) |
| IMP | Investigational Medicinal Product |
| IND | Investigational New Drug |
| IR | Immediate Release |
| IRB | Institutional Review Board |
| JFDA | Jordan Food and Drug Administration, Jordan |
| KFDA | Korea Food & Drug Administration, South Korea |
| MA | Marketing Authorization (EU) |
| MCC | Medicines Control Council, South Africa |
| MoH | Ministry of Health |
| MR | Modified Release |
| MRP | Mutual Recognition Procedure (EU) |
| NDA | National Drug Authority, Uganda |
| NfG | Note for Guidance (EMA) |
| NIHS | National Institute for Health Sciences, Japan |
| NIMP | Non Investigational Medicinal Product |
| OECD | Organization for Economic Co-operation and Development |
| OGD | Office of Generic Drugs (FDA) |
| PAHO | Pan American Health Organization |
| PIC/S | Pharmaceutical Inspection Co-operation Scheme |
| PK | Pharmacokinetics |
| Q | Quality (ICH) |
| SFDA | Saudi Food & Drug Authority, Saudia Arabia |
| SFDA | State Food & Drug Administration, China |
| SS | Semisolid |
| SUPAC | Scale-Up and Post-Approval Changes (FDA) |
| TGA | Therapeutic Goods Administration, Australia |
| TPD | Therapeutic Products Directorate (HPFB) |
| WHO | World Health Organization |
