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CLINICAL RESEARCH AND PHARMACOVIGILANCE WEBSITE DATA INPUTS – RESOURCES

The following are some useful regulatory websites accorss the globe.

EDUCATIONAL RESOURCES

Clinical Research, Pharmacovigilance (PV) and Regulatory Website Listing.

Clinical Research, PV and RA Links

Sl. NoRegulatory Authority (RA) / Independent Authority (IA)RA/IARegulatory Authority Links & Sub LinksBrief Explanation regarding the link
Europe
1European Medicine Agency (EMA)RAhttp://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)
2European Medicine Agency (EMA)RAhttp://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
3European Medicine Agency (EMA)RAhttp://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).
4Medicines & 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.
5Medicines & Healthcare products
Regulatory Agency (MHRA, UK)
RA (National Competent Authority)https://www.gov.uk/
drug-safety-update
This link includes Drug safety updates
6Federal 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.
7State instituute for drug control (Czech Republic)RA (National Competent Authority)http://www.sukl.eu/index.phpThis link includes medicines, medical devices, pharmacies, healthcare facilities, pharmaceutical industries, distribution and functions of State institute for drug control
8National 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).
9Federal 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.
10Italian Medicines AgencyRA (National Competent Authority)http://www.agenziafarmaco
.gov.it/en
This link includes about AIFA, activities and director general.
11Spanish Agency for Medicines and Health ProductsRA (National Competent Authority)http://www.aemps.gob.es/This link includes Surveillance, clinical research, legislation and publications
12Medical Products Agency (MPA)RA (National Competent Authority)https://lakemedelsverket.se/This link includes health care, pharmacy and trade, public, Business, press
13Swiss Agency for Therapeutic productsRA (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
14The 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.
15Health Canada (Canada)RAhttp://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.
16USA (U.S. Food and Drug Administration)RAhttp://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
17Drug administration of Vietnam (Vietnam RA)RAhttp://www.dav.gov.vn/
Default.aspx
English version is under construction
Australia
18Therapeutic Goods Administration (TGA), AustraliaRAhttps://www.tga.gov.au/This link gives information on safety, useful information to health professionsal & consumers, pharmaceutical industry & regulatry authority in Australia.
China
19China Food and Drug Administration (CFDA)RAhttp://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
20Egyptian Drug Authority (EDARAhttp://www.eda.mohealth.gov.eg/This link provides information about Egyptian Drug Authority (EDA), legislation, safety & quality etc.
Indonesia
21The National Agency of Drug & Food Control (NA-DFC)RAhttp://www.pom.go.id
/index.php/home/en
This link provides information about Indonesia regulatory authority (NA-DFC).
Pakistan
22Drug Regulatory Authority of Pakistan (DRAP)RAhttp://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
23Food And Drug Administration PhilippinesRAhttp://www.fda.gov.ph/
about-food-and-drug-administration
This link provides general infrormation Philippines drug regulatory authority.
24Food And Drug Administration PhilippinesRAhttp://www.fda.gov.ph/consumers-corner/registered-drugs-2This link provides infrormation on drugs approved in Philippines.
25Food And Drug Administration PhilippinesRAhttp://www.fda.gov.ph/This link provides infrormation on registered vaccines and biological products in Philippines.
Korea
26Korea Food and Drug Administration (KFDA)RAhttp://eng.kfda.go.kr/index.htmlThis link provides general infrormation Korea drug regulatory authority.
Japan
27Pharmaceuticals & Medical devices Agency (PMDA)RAhttp://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 trailshttp://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 Datahttp://www.centerwatch.com/
Clinical Research and the HIPAA Privacy Rulehttp://privacyruleandresearch.nih.gov/clin_research.asp
E6 Good Clinical Practice Consolidated Guidancehttp://www.fda.gov/
RegulatoryInformation/Guidances/default.htm
Association of Clinical Research Professionalswww.acrpnet.org
Regulatory Affairs Professional Societywww.raps.org
American Medical Writer Associationwww.amwa.org
American Association of Pharmaceutical Scientistswww.aaps.org
Society for Clinical Data Managementwww.scdm.org

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SAS Press and SAS Documentation Example Code and Data

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Clinical – Resource Weblinks

Global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata

http://www.cdisc.org/

U.S. Food and Drug Administration (FDA)

http://www.fda.gov

ClinicalTrials.gov - registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.

http://www.clinicaltrials.gov/

EMEA

http://www.ema.europa.eu

Society for Clinical Data Management

http://scdm.org/

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