European Free Trade Association

At the European level, the national organizations from both the EU (European Union, formerly the EEC) and the EETA (European Free Trade Association) are grouped in the CEN (European Committee for Standardization) and its counterpart for the electrical industries CENELEC. The standards published by these two organizations have authority in all EU countries as well as the EFTA countries who have voted their approval, which means that these standards have replaced their corresponding national standards. 

Founded in 1990, the International Conference on Harmonization (ICH) is comprised of the pharmacopeial manufacturers associations in Europe (EFPIA), Japan (JPMA), the United States (PMA), and the drug regulatory agencies in Europe (EEC), Japan (MHW), and the United States (FDA), with the International Federation of Pharmaceutical Manufacturers Association (IFPMA) serving as secretariat. Pharmacopeias are not members of the ICH, where membership is reserved for three PMAs and three regulatory agencies. Invited observers include Canada, WHO, and the European Free Trade Association (EFTA). 

European Free Trade Association, presently comprising Iceland, Liechtenstein, Norway and Switzerland. European countries, that are not EU Member States, can cooperate with EU via EFTA. 

Contrary to the organizations mentioned so far, the Pharmaceutical Inspection Convention (PIC) was conceived by the health authorities of 10 member countries of the European Free Trade Association (EFTA) in 1970. The main goals of this legal treaty were to harmonize GMP requirements across the member countries and to recognize GMP inspections mutually. The PIC issued Basic Standards for GMP for Pharmaceutical Products in 1973. It was partly based on the WHO standard, partly on national guidelines. In its 1989 revision some basic requirements regarding validation (including definitions of validation and qualification) were spelled out. 

All the above-mentioned legal treatises apply to the European Economic Area (EEA this comprises the 27 EU member states plus Liechtenstein, Iceland, and Norway—Switzerland chose by referendum not to join the EEA, but has certain Swiss-EU bilateral agreements). Switzerland acts as the representative of the European Free Trade Association, which is an observer in the ICH (International Conference on Harmonization) process, accepts ICH guidelines, but is not part of the European Economic Area. There is a legal obligation for the Swiss competent authority, Swiss Agency for Therapeutic Products (Swissmedic), to take account of decisions/authorizations in other territories that have equivalent medicinal product control. 

The European Free Trade Association (EFTA) countries have set up an exchange of Pharmaceutical Experts Reports (PER) between evaluation authorities of participating countries. The Netherlands has been a full member of EFTA since 1991. For The Netherlands the exchange concerns products that have been submitted and registered after 1 January 1991. However, before a report is sent to another country, the marketing authorisation (MA) holder in The Netherlands is asked permission to do so. 

Politically neutral, Switzerland is not a member of the United Nations or the EU but it is a member of the remnants of the European Free Trade Association (EFTA) along with Norway, Iceland and Liechtenstein. Recently, trade links with Canada have been discussed. 

The European Commission (EC) and European Free Trade Association (EFTA) have established a single market in Europe, a free trade of products and services. For machinery... 

Their work is overseen by General Assembly and Technical Boards of representatives of the standard-making bodies of Member States. Member States include EU members, European Free Trade Association (EFTA) members plus affiliates from Eastern European and Middle Eastern countries. 

The ICH committee consists of six members the European Commission of the European Union (EU), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Ministry of Health and Welfare, Japan (MHW), the Japan Pharmaceutical Manufacturers Association (JPMA), the US. Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA). Additional members include observers from the World Health Organization (WHO), European Free Trade Association, and Canada (Health Canada). The International Federation of Pharmaceutical Manufacturers and Associations (IFPM A) has been closely involved with ICH since its inception. This mixture of governmental agencies and professional representatives is performing an exceptional task developing one set of guidelines for three major markets. 

In 1994 the European Union Member States and the countries of the European Free Trade Association (EFTA) (except Switzerland) joined to become the European Economic Area (EEA). 

EU European Union EFTA European Free Trade Association ... 

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