Global Regulations

REGULATORY APPROVALS – SERVICES OFFERED -1. Product licensing ; 2. Site licensing ; 3.Good manufacturing practices ; 4. Labelling ; COMPLIANCE – 1. Compliance Policy for NHP ; 2 NHP Compliance Guide

LICENSING – 1 Licensed NHP Database ; 2 License Applications & Submissions Site License Process ; 3. Product License Process (NPN or DIN-HM)

Useful Links:

ASSOCIATION OF SOUTHEAST ASIAN NATIONS (ASEAN) www.aseansec.org

AGRI-FOOD & VETERINARY AUTHORITY (AVA) Food Labeling

HEALTH SCIENCES AUTHORITY (HSA) Health Supplements

MALAYSIA (1)Ministry of Health  (2)Food Safety and Quality Division standards  (3)Drug Control Authority – establishment

VIETNAM MINISTRY OF HEALTH www.moh.gov.vn

EUROPA Food Safety – From the Farm to the Fork

EUROPEAN FEDERATION OF ASSOCIATIONS OF HEALTH PRODUCT MANUFACTURERS (EPHM) Health Claims

THE EUROPEAN FOOD INFORMATION COUNCIL www.eufic.org

EUROPEAN FOOD SAFETY ASSOCIATION (EFSA) www.efsa.eu.int

DELEGATION OF THE EUROPEAN COMMISSION TO THE U.S.A. www.eurunion.org

FOOD STANDARDS AGENCY (1)www.food.gov.uk  (2)European Legislation

THE HISTORY OF THE EU: THE EUROPEAN CITIZENSHIP Treaty of Rome

UNIVERSITY OF CALIFORNIA BERKELEY EU Internet Resources

WORLD INSTITUTE OF NATURAL HEALTH SCIENCES Legislation

THE HONG KONG HEALTH FOOD ASSOCIATION (HKHFA) www.hkhfa.org/index.html

MODERNIZED CHINESE MEDICINE INTERNATIONAL ASSOCIATION www.mcmia.org

PHARMACEUTICAL SERVICE DEPARTMENT OF HEALTH (1)www.psdh.gov.hk  (2)Food and Health Bureau  (3)Department of Health  (4)Chinese Medicine Council of HK  (5)Pharmaceutical Product Licensing

MINISTRY OF HEALTH, LABOUR AND WELFARE (1) www.mhlw.go.jp   (2) Food with Nutrient Function Claim  (3) Agri-Food Trade Service

KOREAN (1) Regulations for HFF  (2) Health Functional Food Acts  (3) Agri-food Trade Service

TAIWAN (1) Food-related Laws and Regulations  (2) Taiwan’s Compendium on Medicinal Plants  (3) Report on Regulation of Health Food in Taiwan  (4) Department of Health  (5) Agri-food Trade Service

CORNELL UNIVERSITY LAW SCHOOL Code of Federal Regulations

DEPARTMENT OF AGRICULTURE National Nutrient Database

DEPARMENT OF COMMERCE www.osec.doc.gov

DSHEA (1) Implementation of the DSHEA of 1994  (2)Guidance, Compliance & Regulatory Information  (3) Who is responsible?

ENVIRONMENTAL PROTECTION AGENCY www.epa.gov

FEDERAL TRADE COMMISSION www.ftc.gov

GPO ACCESS Code of Federal Regulations

US FOOD AND DRUG ADMINISTRATION (1) www.fda.gov  (2) FDA’s role

FAO/WHO FOOD STANDARDS (1) www.codexalimentarius.net  (2) Official Standards Lis