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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. No Regulatory Authority (RA) / Independent Authority (IA) RA/IA Regulatory Authority Links & Sub Links Brief Explanation regarding the link Format (Link Content)
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) HTML Web Link
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 HTML Web Link
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). HTML Web Link
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. HTML Web Link
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 HTML Web Link
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. HTML Web Link
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 HTML Web Link
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). HTML Web Link
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. HTML Web Link
10 Italian Medicines Agency RA (National Competent Authority) http://www.agenziafarmaco
.gov.it/en
This link includes about AIFA, activities and director general. HTML Web Link
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 HTML Web Link
12 Medical Products Agency (MPA) RA (National Competent Authority) https://lakemedelsverket.se/ This link includes health care, pharmacy and trade, public, Business, press HTML Web Link
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 HTML Web Link
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. HTML Web Link
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. HTML Web Link
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 HTML Web Link
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 HTML Web Link
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. HTML Web Link
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. HTML Web Link
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. HTML Web Link
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). HTML Web Link
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 HTML Web Link
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. HTML Web Link
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. HTML Web Link
25 Food And Drug Administration Philippines RA http://www.fda.gov.ph/ This link provides infrormation on registered vaccines and biological products in Philippines. HTML Web Link
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. HTML Web Link
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. HTML Web Link
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
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

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