The deadlines for regional implementation are now imminent, however pharmacopoeial harmonisation, as a concept, is not new. From the informal discussions within the pharmaceutical industry over 20 years ago, came the formation, in 1989, of the Pharmacopoeial Discussion Group (PDG), consisting of representatives from the pharmacopoeial authorities of Japan, USA and Europe (Britain withdrew in 1992 having aligned with Europe).

The goal was to attempt to harmonize the differing standards and specifications contained within the regional compendia. It is to such specifications that the true test of harmonization is applied, i.e. for a given set of analytical procedures and acceptance criteria (APAC) the same accept/reject decision should be made regardless of geographical location. In terms of patient welfare this is a significant progression, as the extra work (and cost) involved in the current licensing of pharmaceuticals between jurisdictional boundaries inevitably results in delays to the availability of medicines.

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At about the same time as the formation of the PDG and, recognizing the need for a joint regulatory-industry forum, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was formed in April 1990. Members of the ICH are as follows:

• European Medicines Agency (EMEA)
  
• European Federation of Pharmaceutical Industries and Associations (EFPIA)
  
• Ministry of Health, Labour and Welfare, Japan (MHLW)
  
• Japan Pharmaceutical Manufacturers Association (JPMA)
  
• US Food and Drug Administration (FDA)
  
• Pharmaceutical Research and Manufacturers of America (PhRMA)
  
  

Also present at ICH meetings are the organizations acting as observers and providing the link to non-ICH regions, these include:

• World Health Organization (WHO)
  
• International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
  

The PDG is not a member of the ICH, however as both organizations operate in a similar process driven way, they have evolved to meet in parallel and report freely. It is recognized that the PDG is the primary source of harmonized texts. The IHC, through its expert working groups (EWG) then facilitates the regulatory involvement and approval. The Q4B EWG was specifically set up to address the regulatory acceptability of pharmacopoeial proposals.