Student Resources

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
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
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

Contact Us