ACROSS THE WORLD
CLINICAL RESEARCH AND PHARMACOVIGILANCE UPDATE
The following are some useful regulatory websites accorss the globe.
EDUCATIONAL RESOURCES
Clinical Research, Pharmacovigilance (PV) and Regulatory Website Listing.
- World Health Organization – http://www.who.int/en/
- ICH – http://www.ich.org/home.html
- EUDRALEX – The rules governing the use of medicines in the EU
http://ec.europa.eu/ - EUDRAVIGILANCE – http://eudravigilance.ema.europa.eu/
- NICE – (National Institute of Clinical Excellence) http://www.nice.org.uk/
- EMA – http://www.ema.europa.eu/ema/
- MHRA – http://www.mhra.gov.uk/
- FDA – http://www.fda.gov/
- MHLW – http://www.mhlw.go.jp/english
- PMDA (Japan) – http://www.pmda.go.jp/english/index.html
- KFDA (Korean) – http://eng.kfda.go.kr/index.html
Clinical Research, PV and RA Links
| Sl. No | Regulatory Authority (RA) / Independent Authority (IA) | RA/IA | Regulatory Authority Links & Sub Links | Brief Explanation regarding the link | |
|---|---|---|---|---|---|
| Europe | |||||
| 1 | European Medicine Agency (EMA) | RA | http://www.ema.europa.eu/ema/ | This link includes patient safety, new medicines and public consultations (link sub tabs includes find medicine, human regulatory, veterinary regulatory, committee, news and events, partners and networks) | |
| 2 | European Medicine Agency (EMA) | RA | http://www.ema.europa.eu/ema/ index.jsp?curl=pages/about_us/ general/general_content_000217.jsp |
This links includes ommittees, working parties and other groups | |
| 3 | European Medicine Agency (EMA) | RA | http://www.ema.europa.eu/ema/ index.jsp?curl=pages/regulation/landing/ human_medicines_regulatory.jsp |
This links provides information for companies and individuals involved in developing and marketing medicines for human use in the European Union (EU). | |
| 4 | Medicines & Healthcare products Regulatory Agency (MHRA, UK) |
RA (National Competent Authority) | https://www.gov.uk/government/ organisations/medicines-and- healthcare-products-regulatory-agency |
This link includes Drug and Device alert, Drug safety updates, Report a problem with a medicine or medical device, Blood regulation and safety, Marketing authorizations and licensing guidance, Patient information leaflets and summaries of product characteristics, Drug Analysis Prints (DAPs), Public assessment reports and Medical devices regulation and safety Contact MHRA and All MHRA services and information. | |
| 5 | Medicines & Healthcare products Regulatory Agency (MHRA, UK) |
RA (National Competent Authority) | https://www.gov.uk/ drug-safety-update |
This link includes Drug safety updates | |
| 6 | Federal Agency for Medicines and Health Products (Belgium) | RA (National Competent Authority) | http://www.fagg-afmps.be/en/ | This link includes human medicine, veterinary medicines information for the public notification of adverse reactions or incidents. | |
| 7 | State instituute for drug control (Czech Republic) | RA (National Competent Authority) | http://www.sukl.eu/index.php | This link includes medicines, medical devices, pharmacies, healthcare facilities, pharmaceutical industries, distribution and functions of State institute for drug control | |
| 8 | National Agency for the Safety of Medicine and Health Products (France) | RA (National Competent Authority) | http://ansm.sante.fr/ | This link includes health products, report an adverse reactions, services, publications, records, activities and function of ANSM (National Agency for the Safety of Medicine and Health Products). | |
| 9 | Federal Institute for Drugs and Medical Devices (Federal Institute for Drugs and Medical Devices) | RA (National Competent Authority) | http://www.bfarm.de/EN/ Home/home_node.html |
This link includes about Bfarm agnecy, medicinal products, medical device, Federal opium agency, research and services. | |
| 10 | Italian Medicines Agency | RA (National Competent Authority) | http://www.agenziafarmaco .gov.it/en |
This link includes about AIFA, activities and director general. | |
| 11 | Spanish Agency for Medicines and Health Products | RA (National Competent Authority) | http://www.aemps.gob.es/ | This link includes Surveillance, clinical research, legislation and publications | |
| 12 | Medical Products Agency (MPA) | RA (National Competent Authority) | https://lakemedelsverket.se/ | This link includes health care, pharmacy and trade, public, Business, press | |
| 13 | Swiss Agency for Therapeutic products | RA (National Competent Authority) | https://www.swissmedic.ch/ index.html?lang=en |
This link includes news, medicinal product information, medical devices, authorizations, licensing, market surveillance and functions of agency | |
| North and South America | |||||
| 14 | The Brazilian Health Surveillance Agency (ANVISA-Brazil) | RA | http://portal.anvisa.gov. wps/portal/anvisa-ingles |
This link includes health protection, education and knowledge, news, post marketing surveillance and about agency. | |
| 15 | Health Canada (Canada) | RA | http://www.hc-sc.gc.ca/ index-eng.php |
This link includes about health Canada, consumer product safety, drugs and health products, environmental and work health, food nutrition and science and research. | |
| 16 | USA (U.S. Food and Drug Administration) | RA | http://www.fda.gov/ | This link includes about food, drug, medical devices, radiation-emitting products, vaccines, blood and biologics, animal and veterinary, cosmetics and tobacco products | |
| Asia, The Middle East and Ocean | |||||
| Vietnam | |||||
| 17 | Drug administration of Vietnam (Vietnam RA) | RA | http://www.dav.gov.vn/ Default.aspx |
English version is under construction | |
| Australia | |||||
| 18 | Therapeutic Goods Administration (TGA), Australia | RA | https://www.tga.gov.au/ | This link gives information on safety, useful information to health professionsal & consumers, pharmaceutical industry & regulatry authority in Australia. | |
| China | |||||
| 19 | China Food and Drug Administration (CFDA) | RA | http://eng.sfda.gov.cn/ WS03/CL0755/ |
This link provides information about CFDA, regulatory guide to medical devices, imported products, drug law, food & cosmetics in China. | |
| Egypt | |||||
| 20 | Egyptian Drug Authority (EDA | RA | http://www.eda.mohealth.gov.eg/ | This link provides information about Egyptian Drug Authority (EDA), legislation, safety & quality etc. | |
| Indonesia | |||||
| 21 | The National Agency of Drug & Food Control (NA-DFC) | RA | http://www.pom.go.id /index.php/home/en |
This link provides information about Indonesia regulatory authority (NA-DFC). | |
| Pakistan | |||||
| 22 | Drug Regulatory Authority of Pakistan (DRAP) | RA | http://www.dra.gov.pk/gop /index.php?q=aHR0cDov LzE5Mi4xNjguNzAuMTM2L2RyYXAv |
This link gives information about 1.Drug Regulatory Authority of Pakistan Act, 2012, 2. Drugs Act, 1976 3. SROs4. The Drugs (Labelling and Packing) Rules, 19865. The Drugs (Licensing, Registering & Advertising) Rules, 19766. The Drugs (Appellate Board) Rules, 19767. The Drugs (Research) Rules, 19788. The Drugs (Federal Inspectors, Federal Drug Laboratory & Federal Government Analysts) Rules, 19769. The Drugs (Imports & Exports) Rules, 197610. The Drugs (Specifications) Rules, 197811. The Northern Areas Drugs Rules, 199612. Pharmacy Act, 1967 | |
| Philippines | |||||
| 23 | Food And Drug Administration Philippines | RA | http://www.fda.gov.ph/ about-food-and-drug-administration |
This link provides general infrormation Philippines drug regulatory authority. | |
| 24 | Food And Drug Administration Philippines | RA | http://www.fda.gov.ph/consumers-corner/registered-drugs-2 | This link provides infrormation on drugs approved in Philippines. | |
| 25 | Food And Drug Administration Philippines | RA | http://www.fda.gov.ph/ | This link provides infrormation on registered vaccines and biological products in Philippines. | |
| Korea | |||||
| 26 | Korea Food and Drug Administration (KFDA) | RA | http://eng.kfda.go.kr/index.html | This link provides general infrormation Korea drug regulatory authority. | |
| Japan | |||||
| 27 | Pharmaceuticals & Medical devices Agency (PMDA) | RA | http://www.pmda.go.jp/english/ | This link provides the information pertaining to the Regulatory authority (Japan specific), information useful for healthcare professionals, academic information related to pharmaceuticals & pharmaceuticals business purpose. This link also gives information related to the postmarketing safety measures, releif services for adverse health effect, regulatory science & standard development, & international activities. |
|
| Other Links – Useful Websites and Professional Organizations | |||||
| The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) | http://www.ich.org | ||||
| The National Cancer Institute (NCI) and clinical trails | http://www.cancer.gov/clinicaltrials | ||||
| ClinicalTrials.gov – registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. | http://www.clinicaltrials.gov/ | ||||
| Source for Clinical Research Information and Data | http://www.centerwatch.com/ | ||||
| Clinical Research and the HIPAA Privacy Rule | http://privacyruleandresearch.nih.gov/clin_research.asp | ||||
| E6 Good Clinical Practice Consolidated Guidance | http://www.fda.gov/ RegulatoryInformation/Guidances/default.htm |
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| Association of Clinical Research Professionals | www.acrpnet.org | ||||
| Regulatory Affairs Professional Society | www.raps.org | ||||
| American Medical Writer Association | www.amwa.org | ||||
| American Association of Pharmaceutical Scientists | www.aaps.org | ||||
| Society for Clinical Data Management | www.scdm.org | ||||