Richtlinien & Normen
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Richtlinien & Standards
| Standard/ Guideline | Name |
| Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities | AAMI ST79 |
| Sterilization of health care productsRadiation sterilization—Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits | AAMI TIR35:2016/(R)2021 |
| Sterilization of health care products - Radiation - Guidance on sterilization of human tissue-based products | AAMI TIR37: 2013 |
| Sterilization of health care products-Radiation | AAMI TIR40:2018 |
| Guidelines on the Calibration of Temperature and/or Humidity Controlled Enclosures | AFNOR NF X 15-140 |
| Dry heat (heated air) sterilizers | ANSI/AAMI ST50:2004/(R)2018 |
| Table-top steam sterilizers | ANSI/AAMI ST55:2016/(R)2023 |
| Comprehensive guide to steam sterilization and sterility assurance in health care facilities | ANSI/AAMI ST79 |
| Hospital steam sterilizers | ANSI/AAMI ST8:2013/(R)2018 |
| Sterilization of health care products - Radiation | ANSI/AAMI/ISO 11137-03: 2017 |
| Sterilization of health care products—Biological indicators—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes | ANSI/AAMI/ISO 11138-5:2017/(R)2024 |
| Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD | ANSI/AAMI/ISO 13004:2022 |
| Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices | ANSI/AAMI/ISO 14937:2009/(R)2013 |
| Sterilization of health care products -Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices | ANSI/AAMI/ISO 11135:2014 |
| Sterilization of health care products - Moist Heat | ANSI/AAMI/ISO TIR17665-2:2009/(R)2016 |
| Sterilization of health care products - Chemical indicators | CAN/CSA-ISO 11140-3 |
| Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards | CSA ISO 11139 |
| Sterilization of health care products - Microbiological methods | CSA ISO 11737-1 |
| Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010, IDT) | CSA ISO 20857 |
| Sterilization of health care products - Moist heat | CSA Z17665-1 |
| Electrical laboratory devices - Heating ovens and incubators | DIN 12880 |
| Requirements for the validation of cleaning and disinfection processes | DIN 58341 |
| Sterilization of health care products - Radiation - Confirmation of selected sterilization dose: Method | DIN CEN ISO/TS 13004 |
| Biotechnology - Performance criteria for steam sterilizers and autoclaves | DIN EN 12347 |
| Temperature recorders for the transport, storage and distribution of temperature | DIN EN 12830 |
| Sterilization - Steam sterilizers - Large sterilizers | DIN EN 13060 |
| Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing | DIN EN 14180 |
| Controlled environment storage cabinet for processed thermolabile endoscopes | DIN EN 16442 |
| Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing | DIN EN 17180 |
| Sterilization - Steam sterilizers - Large sterilizers | DIN EN 285 |
| Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization | DIN EN 550 |
| Sterilization of medical devices - Validation and routine control of sterilization by moist heat | DIN EN 554 (replaced by DIN ISO 17665) |
| Sterilization of medical devices | DIN EN 556 |
| Environmental testing | DIN EN 60068 |
| Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers | DIN EN 867-5 |
| General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices | DIN EN ISO 14937 |
| Sterilization of health-care products - Ethylene oxide; Requirements for the development, validation and routine control of a sterilization process for medical devices | DIN EN ISO 11135 |
| Sterilization of health care products - Biological indicators | DIN EN ISO 11138 |
| Sterilization of health care products - Chemical indicators | DIN EN ISO 11140 |
| Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results | DIN EN ISO 15882 |
| Washer-disinfector; Performance requirements and test method criteria for demonstrating cleaning efficacy. | DIN EN ISO 15883 |
| Sterilization of health care products - Biological and chemical indicators - Test equipment | DIN EN ISO 18472 |
| Specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices | DIN EN ISO 20857 |
| Sterilizers for medical purposes - Small steam sterilizers | DIN EN ISO 13060 |
| Calibration of Climatic Chambers | DKD-R 5-7 |
| Manufacture of Sterile Medicinal Products | EU GMP Annex 01 |
| Manufacture of Biological Medicinal Products for Human Use | EU GMP Annex 02 |
| Manufacture of Radiopharmaceuticals | EU GMP Annex 03 |
| Computerised Systems | EU GMP Annex 11 |
| Qualification and Validation | EU GMP Annex 15 |
| Pharmaceutical Quality System | EU GMP Chapter 1 |
| Premises and Equipment | EU GMP Chapter 3 |
| Production | EU GMP Chapter 5 |
| Quality Control | EU GMP Chapter 6 |
| Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs | FDA 21 CFR part 210 |
| Current Good Manufacturing Practice for Finished Pharmaceuticals | FDA 21 CFR part 211 |
| Regulations on electronic records and electronic signatures | FDA 21 CFR part11 |
| FDA Guide to Inspections of Lyophilization of Parenteral | FDA Inspection Guide |
| FDA Guide to Inspections of Sterile Drug Substance Manufacturers | FDA Inspection Guide |
| FDA Guide to Inspections of Pharmaceutical Quality Control Labs | FDA Inspection Guide |
| FDA Guide to Inspections of Foreign Medical Device Manufacturers | FDA Inspection Guide |
| FDA Guide to Inspections of Foreign Pharmaceutical Manufacturers | FDA Inspection Guide |
| FDA Inspection Technical Guide Water for Pharmaceutical Use | FDA Inspection Guide |
| FDA Instection Technical Guide Expiration Dating and Stability Testing for Human Drug Products | FDA Inspection Guide |
| Validation and periodic testing of the various sterilization processes used in hospitals, laboratories and other healthcare facilities | HTM 2010 |
| Stability testing of active pharmaceutical ingredients and finished pharmaceutical products | ICH Guideline - Annex10 |
| Targeted Revisions of the ICH Stability Guideline Series | ICH Guideline - Q1/Q5C EWG |
| Pharmaceutical Quality System | ICH Guideline - Q10 |
| Stability testing of Biotechnological / Biological products | ICH Guideline - Q1A |
| Stability testing of New Drug Substances and Products | ICH Guideline - Q5C |
| Quality Risk Management | ICH Guideline - Q9 |
| Stability Testing of new drug substances and products | ICH Q1A (R2) |
| Environmental testing | IEC 60068 |
| Thermocouples | IEC 60584-1 |
| Industrial Platinum Resistance Thermometers | IEC 60751 |
| ILAC Guidelines for Measurement Uncertainty in Testing | ILAC G17 |
| Measurement management systems — Requirements for measurement processes and measuring equipmen | ISO 10012 |
| Sterilization of health care products; requirements for validation and routine control; industrial moist heat sterilization | ISO 11134 |
| Sterilization of health care products - Radiation | ISO 11137 |
| Sterilization of health care products - General requirements for characterization of a sterilizing agent and for the development, validation and routine control of a sterilization process | ISO 14937 |
| Sterilization of health care products - Moist heat | ISO 17665 |
| Testing and calibration laboratories | ISO/IEC 17025 |
| Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical d | ISO/WD 22441 |
| Controlled Temperature Chamber Mapping and Monitoring | ISPE Good Practice Guide |
| Validation of Moist Heat Sterilization Processes Cycle Design, Development, Qualification and Ongoing Control | PDA Technical Report No. 01 |
| Validation of Dry Heat Processes Used for Depyrogenation and Sterilization | PDA Technical Report No. 03 |
| Design Concepts For the Validation of a Water for Injection System | PDA Technical Report No. 04 |
| Parametric Release of Pharmaceuticals and Medical Device Products Terminally Sterilized by Moist Heat | PDA Technical Report No. 30 |
| Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products | PDA Technical Report No. 34 |
| Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification | PDA Technical Report No. 48 |
| Implementation of Quality Risk Management For Pharmaceutical and Biotechnology Manufacturing Operations | PDA Technical Report No. 54 |
| Process Validation: A Lifecycle Approach Annex 1: Oral Solid Dosage/Semisolid/ Dosage Forms | PDA Technical Report No. 60 |
| Data Integrity Management System for Pharmaceutical Laboratorie | PDA Technical Report No. 80 |
| Guide to Good Manufacturing Practice for Medicinal Products | PIC/S (PE 009-17) |
| Chapters on Good Storage and Distribution Practices | USP (1079) Series |
| Monitoring Devices—Time, Temperature, and Humidity | USP〈1118〉 |
| WHO Guidelines on quality and risk management | WHO Guidelines |
Organisationen
| Name | Website |
| AALAS (American Association for Laboratory Animal Science) | https://www.aalas.org |
| AAMI (Association for Advancedment of Medical Instrumentation) | https://www.aami.org |
| AAMI (Association for the Advancement of Medical Instrumentation) | https://www.aami.org |
| AFAR (Association francaise des affaires rékemntaires) | https://www.afar.asso.fr |
| CEN (European Commitee for Standardization) | https://www.cencenelec.eu |
| DIN (German Institute for Standardization) | https://www.din.de |
| EDQM (European Directorate for the Quality of Medicines & HealthCare) | https://www.edqm.eu |
| EMA (European Medicines Agency) | https://www.ema.europa.eu |
| EuropaBio (European Association for Bioindustries) | https://www.europabio.org |
| GCCA (Global Cold Chain Alliance) | https://www.gcca.org |
| HMA (European Heads of Medicines Agencies) | https://www.hma.eu |
| ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Hu | https://www.ich.org |
| ISO (International Organization for Standardization) | https://www.iso.org |
| ISPE (International Society for Pharmaceutical Engineering) | https://ispe.org |
| ispe (International Society for Pharmacoepidemilogy) | https://www.pharmacoepi.org |
| NCSL (National Conference of Standards Laboratories) | https://www.ncsl.org |
| NIST (National Institute of Standards and Technology) | https://www.nist.gov |
| OECD (Organisation for Economic Co-operation and Development: Good Laboratory Practice (GLP)) | https://www.oecd.org |
| PDA (Parenteral Drug Association) | https://www.pda.org |
| PIC/S (Pharmaceutical Inspection Co-operation Scheme) | https://picscheme.org |
| PTB (Physikalisch-Technische Bundesanstalt) | https://www.ptb.de |
| SIARV (Società Italiana Attività Regolatorie, Accesso, FarmacoVigilanza ) | https://www.siarv.it |
| TOPRA (Professionals in Regulatory Affairs) | https://www.topra.org |
| WHO (World Health Organization) | https://www.who.int |
| DAkkS (German Accreditation Body) | https://www.dakks.de |
Branchenverbände Pharma
| By Region | Name |
| Global Trade Associations | IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) |
| Central America | Fedefarma (Federation of Central American Pharmaceutical Laboratories) |
| Europe | Medtech Europe (Medical Devices Association) |
| Europe | EFPIA (European Federation of Pharmaceutical Industries and Associations) |
| Gulf | PhRMAG (Pharmaceutical Research and Manufacturers Association Gulf) |
| Middle East and Africa | PhRMA MEA (Pharmaceutical Research & Manufacturers of America Middle East & Africa) |
| By Country | Name |
| Algeria | UNOP (National Association of Pharmaceutical Corporations) |
| Argentina | CAEMe (Argentine Chamber of Medical Specialties) |
| Australia | Medicines Australia (Pharmaceutical Industry Association) |
| Austria | PHARMIG (Pharmaceutical Industry Association) |
| Austria | FOPI (Pharmaceutical Industry Association of researching pharma companies in Austria) |
| Austria | OVIH (Austrian Association of Vaccine Manufacturers) |
| Belarus | BAIPM (Belarus Association of International Pharmaceutical Manufacturers) |
| Belgium | pharma.be (Belgian Pharmaceutical Trade Association) |
| Belgium | Essenscia (Federation of Chemistry & Life Science Industry) |
| Brazil | Interfarma (Association of Pharmaceutical Research-based Industry) |
| Canada | IMC (Innovative Medicines Canada) |
| Chile | CIF (Chamber of Pharmaceutical Industry) |
| China | RDPAC (R&D-based Pharmaceutical Association Committee) |
| Colombia | AFIDRO (Association of Pharmaceutical R&D companies) |
| Czech Republic | AIFP (Association of the Innovative Pharmaceutical Industry) |
| Denmark | LIF (The Danish Association of the Pharmaceutical Industry) |
| Dominican Republic | ARAPF (National Association of Pharmaceutical Companies) |
| Ecuador | IFI (Pharmaceutical R&D Industry Association) |
| Egypt | Pharmaceutical Cosmetics & Appliances Chamber |
| Finland | PIF (Pharmaceutical Industry Finland) |
| France | LEEM (French Pharmaceutical Industry Association) |
| Germany | BAH (Federation of Pharmaceutical Manufacturers) |
| Germany | Vfa (Trade Association for Research-based Pharmaceutical Companies) |
| Greece | SFEE (Hellenic Association of Pharmaceutical Companies) |
| Hong Kong | HKAPI (Hong Kong Association of the Pharmaceutical Industry) |
| Ireland | IPHA (Irish Pharmaceutical Healthcare Association) |
| India | OPPI (Organisation of Pharmaceutical Producers of India) |
| Indonesia | IPMG (International Pharmaceutical Manufacturers Group) |
| Israel | The Association of Research-based Pharmaceutical Companies |
| Italy | Farmindustria (Association of Pharmaceutical Companies) |
| Japan | JPMA (Japan Pharmaceutical Manufacturers' Association) |
| Japan | Japanese Association of Vaccine Industries |
| Kazakhstan | AIPM (Association of International Pharmaceutical Manufacturers) |
| Kenya | KAPI (Kenya Association of Pharmaceutical Industry) |
| Korea | KRPIA (Korea Research-based Pharmaceutical Industry Association) |
| Korea | KOBIA (Korea Biomedicine Industry Association) |
| Korea | KPTA (Korea Pharmaceutical Traders Association) |
| Luxembourg | APL (Pharmaceutical Association of Luxembourg) |
| Malaysia | PhAMA (Pharmaceutical Association of Malaysia) |
| Mexico | AMIIF (Mexican Association of Pharmaceutical Research Industries) |
| Morocco | LEMM (Les Entreprises du Médicament Marocaines - Research-based Pharmaceutical Assoc |
| Netherlands | Association for Innovative Medicines |
| Netherlands | HollandBio |
| New Zealand | Medicines New Zealand |
| Nigeria | NIROPHARM (Association of Representatives of Overseas Pharmaceutical Manufacturers) |
| Nigeria | PMG - MAN (Pharmaceutical Manufacturers Group of the Manufacturers Association of Nige |
| Norway | LMI (The Pharmaceutical Industry Association) |
| Pakistan | Pharma Bureau |
| Peru | ALAFARPE (National Association of Pharmaceutical Laboratories) |
| Philippines | PHAP (Pharmaceutical and Healthcare Association of the Philippines) |
| Poland | INFARMA (Employers’ Union of Innovative Pharmaceutical Companies) |
| Portugal | APIFARMA (Portuguese Association of Pharmaceutical Industry) |
| Russia | AIPM (Association of International Pharmaceutical Manufacturers) |
| Saudi Arabia | RPCC (Research-based Pharmaceutical Companies Group) |
| Singapore | SAPI (Singapore Association of Pharmaceutical Industries) |
| South Africa | IPASA (Innovative Pharmaceutical Association SA) |
| Spain | Farmaindustria (R&D Pharmaceutical Association) |
| Sri Lanka | Sri Lanka Chamber of Pharmaceutical Industry |
| Sweden | LIF (The Research-based Pharmaceutical Industry Association) |
| Switzerland | Scienceindustries |
| Switzerland | Interpharma (Pharmaceutical Industry Association) |
| Taiwan | IRPMA (International Research-based Pharmaceutical Manufacturers' Association) |
| Taiwan | CAPA (Chinese Association for Pharmaceutical Agents) |
| Thailand | PreMA (The Pharmaceutical Research and Manufacturers' Association) |
| Tunisia | SEPHIRE (Association of Innovative Pharmaceutical Research Companies) |
| Turkey | AIFD (Association of Research-based Pharmaceutical companies) |
| UK | ABPI (Association of the British Pharmaceutical Industry) |
| UK | BIA (BioIndustry Association) |
| Ukraine | APRaD (Association of Pharmaceutical Research and Development) |
| Uruguay | CEFA (Chamber of Pharmaceutical and Related Specialties) |
| USA | PhRMA (Pharmaceutical Research and Manufacturers of America) |
| USA | BIO (Biotechnology Industry Organisation) |
| Venezuela | CAVEME (Venezuelan Chamber of Medicines) |
| Vietnam | Pharma Group (The Pharmaceutical Sector Committee of EuroCham) |
Lokale Behörden
| Country | Authorities | Website |
| Argentina | National Administration of Drugs, Foods and Medical Devices | www.argentina.gob.ar/anmat |
| Armenia | Scientific Center of Drug and Medical Technologies Expertise (SCDMTE) | www.pharm.am |
| Australia | Therapeutic Goods Administration (TGA) | www.tga.gov.au |
| Austria | Australian Pesticides and Veterinary Medicines Authority (APVMA) | apvma.gov.au |
| Austria | Austrian Agency for Health and Food Safety | www.ages.at |
| Austria | Austrian Federal Office for Safety in Health Care | www.basg.gv.at |
| Azerbaijan | Azerbaijan Ministry of Health, Analytical Expertise Center | www.sehiyye.gov.az/ |
| Belarus | Center for Examinations and Tests in Health Service | www.rceth.by |
| Belgium | Federal Agency for Medicines and Health Products (FAMHP) | www.afmps.be |
| Brazil | Brazilian Health Regulatory Agency | www.gov.br/anvisa |
| Bulgaria | Bulgarian Drug Agency | www.bda.bg |
| Bulgaria | Bulgarian Food Safety Agency, Veterinary medicinal products | www.babh.government.bg |
| Canada | Health Canada (HC) / Santé Canada (SC) | www.canada.ca/health-canada |
| Croatia | Agency for Medicinal Products and Medical Devices of Croatia | www.halmed.hr |
| Croatia | Ministry of Agriculture, Veterinary and food safety directorate | www.veterinarstvo.hr |
| Cuba | Center for State Control of Drugs, Equipment and Medical Devices | www.cecmed.cu |
| Cyprus | Ministry of Health, Pharmaceutical Services | www.moh.gov.cy |
| Czech Republic | State Institute for Drug Control | www.sukl.cz |
| Czech Republic | Institute for State Control of Veterinary Biologicals and Medicaments | www.uskvbl.cz |
| Denmark | Danish Medicines Agency | laegemiddelstyrelsen.dk |
| Egypt | Egyptian Drug Authority (EDA) | norcb.gov.eg/?page_id=1360 |
| Estonia | State Agency of Medicines | ravimiamet.ee |
| Finland | Finnish Medicines Agency (fimea) | www.fimea.fi |
| France | French National Agency for Medicines and Health Products Safety | ansm.sante.fr |
| France | The French Agency for Veterinary Medicinal Products / French Agency for Food, Environmental and Occupational Health & Safety | www.anses.fr |
| Germany | Federal Institute for Drugs and Medical Devices | www.bfarm.de |
| Germany | Federal Institute for Vaccines and Biomedicines | www.pei.de |
| Germany | Federal Office of Consumer Protection and Food Safety | www.bvl.bund.de |
| Greece | National Organization for Medicines | www.eof.gr |
| Hungary | National Institute of Pharmacy and Nutrition | ogyei.gov.hu |
| Hungary | National Food Chain Safety Office, Directorate of Veterinary Medicinal Products | www.nebih.gov.hu |
| Iceland | Icelandic Medicines Agency (IMA) | www.ima.is |
| India | Central Drugs Standard Control Organization (CDSCO) | cdsco.gov.in |
| Indonesia | National Agency of Drug and Food Control (NA-DFC) | www.pom.go.id |
| Iran | Iran’s Food and Drug Administration (IFDA) | www.fda.gov.ir |
| Ireland | Health Products Regulatory Authority (HPRA) | www.hpra.ie |
| Ireland | Department of Agriculture, Food and the Marine | www.agriculture.gov.ie |
| Israel | Ministry of Health - Pharmaceutical Division | www.health.gov.il |
| Italy | Italian Medicines Agency | www.aifa.gov.it |
| Italy | National Institute of Health | www.iss.it |
| Italy | Ministry of Health, Directorate-General for animal health and veterinary medicinal products | www.salute.gov.it |
| Japan | Pharmaceuticals and Medical Devices Agency (PMDA) | www.pmda.go.jp |
| Kazakhstan | National Center for Expertise of Medicines and Medical Devices | www.ndda.kz |
| Latvia | State Agency of Medicines of Latvia | www.zva.gov.lv |
| Latvia | Food and Veterinary Service | www.pvd.gov.lv |
| Liechtenstein | Office of Health/Dpt. of Pharmaceuticals | www.llv.li |
| Lithuania | State Medicines Control Agency | www.vvkt.lt |
| Lithuania | State Food and Veterinary Service; | vmvt.lt |
| Lithuania | National Food and Veterinary Risk Assessment Institute | nmvrvi.lrv.lt |
| Luxembourg | Ministry of Health | www.ms.etat.lu |
| Malaysia | National Pharmaceutical Regulatory Agency (NPRA) | npra.gov.my |
| Malta | Malta Medicines Authority (MMA) | www.medicinesauthority.gov.mt |
| Malta | Veterinary Regulation Directorate | agrifish.gov.mt |
| Mexico | Federal Commission for the Protection against Sanitary Risk | www.gob.mx/cofepris |
| Netherlands | Medicines Evaluation Board (MEB) | www.cbg-meb.nl |
| New Zealand | New Zealand Medicines and Medical Devices Safety Authority (Medsafe) | www.medsafe.govt.nz |
| Norway | Norwegian Medicines Agency (NOMA) | legemiddelverket.no |
| People’s Republic of Chi | National Medical Products Administration (NMPA) | www.nmpa.gov.cn |
| Philippines | Food and Drug Administration Philippines | www.fda.gov.ph |
| Poland | Chief Pharmaceutical Inspectorate | www.gif.gov.pl |
| Poland | Office for Registration of Medicinal Products, Medical Devices and Biocidal Products | urpl.gov.pl/pl |
| Portugal | INFARMED – National Authority of Medicines and Health Products, IP | www.infarmed.pt |
| Portugal | Food and Veterinary Directorate General | www.dgav.pt |
| Romania | National Agency of Medicines and Medical Devices | www.anm.ro |
| Romania | Institute for Control of biological products and veterinary medicines | www.icbmv.ro |
| Russia | Ministry of Health of Russian Federation | minzdrav.gov.ru |
| Russia | Federal Service for Surveillance in Healthcare | roszdravnadzor.gov.ru |
| Saudi Arabia | Saudi Food and Drug Authority (SFDA) | www.sfda.gov.sa |
| Serbia | Medicines and Medical Devices Agency of Serbia (ALIMS) | www.alims.gov.rs |
| Singapore | Health Sciences Authority (HSA) | www.hsa.gov.sg |
| Slovakia | State Institute for Drug Control (SIDC) | www.sukl.sk |
| Slovakia | Institute for State Control of Veterinary Biologicals and Medicaments | www.uskvbl.sk |
| Slovenia | Agency for Medicinal Products and Medical Devices of the Republic of Slovenia | www.jazmp.si |
| South Africa | South African Health Products Regulatory Authority (SAHPRA) | www.sahpra.org.za |
| South Korea | Ministry of Food and Drug Safety (MFDS) | www.mfds.go.kr |
| Spain | Spanish Agency of Medicines and Medical Devices | www.aemps.gob.es |
| Sweden | Medical Products Agency | www.lakemedelsverket.se |
| Switzerland | Swissmedic | www.swissmedic.ch |
| Tajikistan | Ministry of Health and Social Protection of the Population of the Republic of Tajikistan | moh.tj |
| Thailand | Food and Drug Administration (Thai FDA) | www.fda.moph.go.th |
| Turkey | Turkish Medicines and Medical Devices Agency (TMMDA) | www.titck.gov.tr |
| Ukraine | State Service of Ukraine on Medicines and Drugs Control (SMDC) | www.dls.gov.ua |
| United Kingdom | Medicines and Healthcare products Regulatory Agency (MHRA) | https://www.gov.uk |
| United Kingdom | Veterinary Medicines Directorate (VMD) | www.gov.uk |
| United States | U.S. Food and Drug Administration (FDA) | www.fda.gov |