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INTRODUCTION
This page is intended to help make sense of the various regulatory and industry websites relevant to those in pharmacovigilance. This page is intended as a guide only. Any feedback on improvements can be sent to: interneteditor@pipaonline.org
REGULATORY BODIES
EUROPE
The European Commission (EC) is responsible for setting legislation and corresponding guidance for those countries in the European Union (EU). Centrally authorised and mutual recognition products are covered by this legislation and guidance. The EC governing body responsible for the pharmaceutical industry is the European Medicines Agency (EMEA) http://www.emea.europa.eu
Relevant guidance for industry includes but is not limited to Eudralex - Volume 9 http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol9_en.htm.
Countries in the EU still have their own National Competent Authorities (NCAs) who are bound by the legislation set down by the EC, but may also add or modify the requirements within that particular country. Any nationally approved product will fall under the remit of the NCA of the country that that product is licensed in. For the United Kingdom (UK) the NCA is the Medicines Health Regulation Authority (MHRA) http://www.mhra.gov.uk/index.htm. Other NCAs in Europe include but are not limited to AFSSaPs in France http://translate.google.co.uk/translate?hl=en&sl=fr&u=http://afssaps.sante.fr/&sa=X&oi=translate&resnum=1&ct=result&prev=/search%3Fq%3Daffsaps%26hl%3Den%26sa%3DG (English translation) and Bfarm in Germany http://www.bfarm.de/cln_030/EN/Home/homepage__node.html__nnn=true (English translation). For more information on all the NCAs try these websites: http://www.hma.eu or http://www.pharmweb.net/pwmirror/pwk/pharmwebk.html.
UNITED STATES of AMERICA (USA)
In America the governing body responsible for the pharmaceutical industry is called the Food and Drug Administration (FDA) and the relevant guidance in the Code of Federal Regulations (CFR) is CFR 21 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm (in particular part 312 and 314).
OTHER REGIONS OF THE WORLD
Outside of Europe and USA, each country has a NCA responsible for providing legislation and guidance for industry, with most countries' NCAs having regular communication with the EMEA and the FDA. Some of those NCAs include Health Canada http://www.hc-sc.gc.ca/index-eng.php , Ministry of Health, Labour And Wealfare (MHLW) in Japan http://www.mhlw.go.jp/english/index.html and the Therapeutic Goods Administration (TGA) in Australia http://www.tga.gov.au/ .As above for websites on the NCAs around the world or try these websites; http://www.hma.eu or http://www.pharmweb.net/pwmirror/pwk/pharmwebk.html
INDUSTRY BODIES - UNITED KINGDOM
Within the UK there are many industry associated bodies, all with slightly different purposes to guide pharmaceutical companies. These include, but are not limited to (ABPI) http://www.abpi.org.uk/ , generic companies (BGMA) http://www.britishgenerics.co.uk/ , over the counter (OTC) medicines (PAGB) http://www.pagb.co.uk/ , Devices http://www.abhi.org.uk, Diagnostics http://www.bivda.co.uk, Quality http://www.barqa.com/cms.php?categoryid=251, Vaccines http://www.uvig.org and importantly, providing support, information and training of Medical Information and Pharmacovigilance individuals: PIPA http://www.pipaonline.org.
IMPORTANT BODIES OR INSTITUTIONS
Most of the regulations in Europe are based on the guidance of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) http://www.ich.org/cache/compo/276-254-1.html and the COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES (CIOMS) http://www.cioms.ch/
