Pharmaceutical/Biotech Information, Equipment Manufacturing Regulations & Industry Resources

Government Pharmaceutical Manufacturing Regulations | Biotech and Pharmaceutical Industry Associations and Affiliations | Pharmaceutical Manufacturing and Engineering Regulations and Standards

Links to the world government agencies that provide regulations and guidance for the pharmaceutical and biotech industries.

Australia

Therapeutics Goods Administration (TGA) Home Page –Australia’s regulatory agency for medical drugs and devices for the pharmaceutical and biotech industries.
www.tga.gov.au
Government Department of Health
www.health.gov.au
Australian Pesticides & Veterinary Medicines Authority
www.apvma.gov.au
Australian Quarantine Inspection Service (AQIS) Home Page – Biocontainment and import/export of products and materials.
www.aqis.gov.au
Office of Gene Technology Regulator (OGTR) Home Page – the regulating body for genetically modified organisms.
www.ogtr.gov.au

	Government Pharmaceutical Manufacturing Regulations

	Pharmaceutical Manufacturing and Engineering Standards

	Biotech and Pharmaceutical Industry Associations & Affiliations

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New Zealand

Medsafe - New Zealand Medicines and Medical Devices Safety Authority
www.medsafe.govt.nz
Australian New Zealand Therapeutics Products Authority (ANZTPA) Home Page – A joint scheme is underway between Australia and New Zealand to regulate medicines (including complimentary medicines) and medical devices. Refer to the ANZTPA for progress.
www.anztpa.org
Ministry of Agriculture and Forestry (MAF) Home Page – Includes veterinary medicines.
www.maf.govt.nz

United States of America

Food and Drug Administration (FDA) Home Page–America’s regulatory agency for the pharmaceutical and biotech industries.
www.fda.gov
Centre of Veterinary Medicines (CVM) Home Page
www.fda.gov/cvm

Europe

European Agency for the Evaluation of Medinical Products (EMEA) Home Page – European pharmaceutical and biotech evaluation body. Individual countries have additional regulating bodies – please contact the Business Biotics Group for a detailed list of country specific governing bodies.
www.emea.eu.int

The home page includes links to the Committee for Medicinal Products for Human Use (CHMP) and Committee for Medicinal Products for Veterinary Use (CVMP).

China

State Food and Drug Administration (SFDA) Home Page – Formerly the State Drug Adminstration (SDA), China’s governing body for the manufacture, trade and registration of pharmaceuticals and biotech products.
www.sfda.gov.cn

India

Central Drugs Standard Control Organisation (CDSCO) Home Page – Regulatory and licensing government department for India pharmaceutical and biotech industries.
www.cdsco.nic.in

For government regulating agencies of other countries please contact the Business Biotics Group

Links to the Associations and Affiliations including general pharma, engineering, scientific and project management.

General Pharmaceutical

Pharmaceutical Inspection Cooperation Scheme (PIC/S)
www.picscheme.org
World Health Organisation (WHO)
www.who.int
Parental Drug Association (PDA) Home Page – Intramuscular and Intravenous drug news and information.
www.pda.org
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) – scientific and technical aspects of product registration.
www.ich.org

Engineering

International Society of Pharmaceutical Engineering (ISPE) Home Page – worlds largest non-profit professional organisation serving pharmaceutical and biotech manufacturing professionals.
www.ispe.org
Engineers Australia Home Page – Revised and updated Institution of Engineers Australia (IEAust) Home Page. General information and news for all aspects of engineering in Australia.
www.engineersaustralia.org.au
Association of Professional Engineers, Scientists and Managers, Australia (APESMA) Home Page
www.apesma.asn.au

Scientific

Biospectrum Asia Home Page – Informative website on the pharma/biotech industries in Asia.
www.biospectrumasia.com
Australia’s Biotechnology Organisation (Ausbiotech) Home Page – Australia wide biotechnology information website.
www.ausbiotech.org
BioGeelong Home Page – News, links and information on the growing Geelong Biotechnology industry.
www.biogeelong.com.au

Project Management

Project Management Institute (PMI) Home Page – Project Management resource website including standards, seminars, education programs and case studies.
www.pmi.org

High level list of Australian and International pharmaceutical regulations and standards

REGULATIONS

Australian

Australian Code of Good Manufacturing Practice for Medicinal Products – Therapeutics Goods Administration 16 August 2002.

Australian Code of Good Manufacturing Practice for Veterinary Chemical Products – Australian Pesticides & Veterinary Medicines Authority.

Australian Regulatory Guidelines for Complementary Medicines – Therapeutics Goods Administration June 2005.

Australian Medical Device Guidelines – Therapeutics Goods Administration

International

United States
Code of Federal Regulations 21CFR 210 - cGMP in Manufacturing, Processing, Packing, or holding of Drugs; General – U.S. Food & Drug Administration

Code of Federal Regulations 21CFR 211 cGMP for Finished Pharmaceuticals – U.S. Food & Drug Administration

Code of Federal Regulations 21CFR 600 - Biologics – U.S. Food & Drug Administration

Europe
Eudralex Volume 4 - Medicinal Products for Human and Veterinary Use : Good Manufacturing Practice – European Commission

STANDARDS

Australian

Australian Standards Home Page.
www.standards.com.au

International Standards

United States Pharmacopeia (USP)
www.usp.org

British Pharmacopoeia (BP)
www.pharmacopoeia.org.uk

European Directorate for the Quality of Medicines (EDQM)
www.pheur.org

International Standards Organisation (ISO)
www.iso.org

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