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This is the study on the transition of the standards and test methods for barbiturates drugs (Bar-d) between JP IV (1920) and JP XII (1991). The results are as follows: Many new Bar-d appeared between JP VI (1951) and JP VIII (1971). Then many kinds of test methods for Bar-d were studied between JP VII (1961) and JP VIII (1971) and common and precise test methods were established. It is thought that Bar-d were used widely as hypnotics and sedatives in the 1960's in Japan, but some Bar-d were eliminated since JP IX (1976). The test methods for Bar-d were never revised after JP VIII (1971). It is thought that the first choice drugs for hypnotics and sedatives in Japan have transferred from Bromides and Bar-d to Benzodiazepines and the demand of Bar-d as hypnotics and sedatives has declined.
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It was proposed as early as in 1860 that a common pharmacopoeia should be worked out in the Nordic countries but it took more than a hundred years before such a pharmacopoeia was published and put into force. Ever since that early date the Nordic countries have, however, been striving for common regulations in the drug field with more or less intensity. The accomplishment of the common pharmacopoeia is therefore to be regarded only as a milestone on the long way to complete conformity of the different national drug regulations. The Nordic Pharmacopoeia has definitely broken through the borderlines of the earlier national pharmacopoeias, which were designed for the activities of the pharmacies, and has obtained recognition as a work on drug standards possible to apply in the manufacture and control of drugs no matter where they are produced or controlled. The Nordic Pharmacopoeia thus has wider functions and a greater responsibility than the earlier pharmacopoeias. This depends partly on the pharmacopoeia itself, partly on the development in the field of drug control. On the other hand the Nordic Pharmacopoeia has left some of the tasks of the earlier pharmacopoeias to different national formularies, manuals and other sources of information. This applies especially to galenical preparations. As expected the Nordic Pharmacopoeia has facilitated drug trade in the Nordic countries to a certain extent and it is no doubt of greatest value in the different control activities of the national health authorities. It is also a guide-book and a reference work for manufacturers and control laboratories of different kinds. But this is what it should be, what it is intended to serve as. In addition to that the Nordic Pharmacopoeia has played an essential role in many other respects; not least as initiator of different progressive work and drawer of guide-lines for future development in the drug field.
The role of a modern pharmacopoeia is to furnish quality specifications for drug substances and general requirements for dosage forms. The existence of such specifications and requirements is necessary for the proper functioning or regulatory control of drugs. Parmacopoeial requirements form a base for establishing quality requirements for individual pharmaceutical preparations in their final form. One hundred and forty independent countries are at present employing some 30 national and 3 regional pharmacopoeias. The aim of the international Pharmacopoeia issued by the World Health Organization as a recommendation, is to achieve a possibly wide global uniformity of quality specifications. The actual second edition of the International Pharmacopoeia was published in 1967 followed by a supplement in 1971. The Expert Committee on Specifications for Pharmaceutical Preparations, which is the body established by the World Health Organization to advise on quality specifications for drugs, during its 25th meeting, held in November 1974, recommended that the new edition of the International Pharmacopoeia should primarily include: -specifications for raw material comprising active and inactive ingredients used in pharmaceutical products; -general methods and tests necessary to support such specifications. Work on the new edition of the International Pharmacopoeia will comprise the revision of existing specifications and requirements, establishing specifications for new pharmaceutical substances, as well as establishing chemical reference substances, necessary to support such specifications. The actual procedure foresees appropriate consultations among the members of the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations. Extensive consultations with pharmacopoeia commissions are taking place to achieve a possibly high degree of unanimity on a global scale towards the quality requirements for pharmaceutical substances.
In every country drug control depends on the existence of technical norms which are generally represented by the Pharmacopoeia. In effects, since the beginning of XIII century, when the profession of pharmacist was for the first time established by law, pharmacopoeias have had not only the purpose of supplying the composition and the preparation of drugs, but also to establish and enforce the quality of the drugs. In the present times the pharmacopoeias adopted throughout the world by the different countries are intended mainly as a codex of specifications for the control of drug quality. These pharmacopoeias are national, regional and international. Nevertheless several difficulties can be found in the use of the pharmacopoeias for control of drugs, owing to the fact that not all the drugs, allowed and in therapeutical use are included in pharmacopoeias, and also because, in some cases, the final control is not sufficient to establish drug quality especially in the case of biological preparations. The existence of a Formulary or "Codex", beyond pharmacopoeia, may be of help for the control authorities but generally is not sufficient. Some suggestions are made in order to envisage a modern pharmacopoeia, considered as a dynamic collection of specifications of drug quality, always up to date, and thus in condition to fulfil its task for the need of the drug control by the health authorities in the aim of a better protection of public health.
Three are the basic features of a medicine legally introduced on the market: efficacy, safety and quality. With regarding to drugs listed in a national or international pharmacopoeia, the ratio between efficacy and safety, within the range of dosage established by the codex, must be considered as official by the industry. As far as quality is concerned, the pharmacopoeia plays a fundamental role in establishing methods of analysis and technical control intended as official reference in case of controversy. The quality of drugs, pharmaceutical adjuvants or preparations listed in a modern pharmacopoeia must be considered by the industry as the minimum level of the acceptable standard for medical use, to ensure efficacy under proper storage conditions. In fact, the specifications are largely based upon suggestions made by manufacturers. Pharmaceutical specialties, being registered by Health Authorities following suitable documentation, do not have to be subjected to the standards established by the pharmacopoeia for new drugs or formulation adjuvants. The constant effort of the manufacturers to minimize risks leads to optimum quality levels, considering that samples used for control by the Health Authorities are usually picked from commercial packages containing a small number of units. To ensure statistical compliance of every sample with official pharmacopoeial standards, manufacturers are forced to exercise the highest care in every process of production and packaging. There cannot possibly be a guarantee that every single unit at the consumer's disposal will actually comply with the quality level established by a modern pharmacopoeia. Optimum quality level in every package of medical products can be achieved by following the "Good Manufacturing Practice" sponsored by the WHO; this goal requires skilled people and sophisticated equipment. The practice of quality control as an essential part of the manufacturing process in a wide range of pharmaceuticals, provides an excellent experience that may be useful to the pharmacopoeial commissions. Therefore a closer co-operation between health officials and industry's experts must be considered the best way to improve the specifications, to speed-up the revision of monographs and to collect reports on stability tests. The part of a modern pharmacopoeia, devoted to tests and standards appears today as the most important for the pharmaceutical industry because, when a controversy arises about drugs, the official methods established by the pharmacopoeia play a fundamental role in the enforcement of law. The task of compiling each new edition of a modern pharmacopoeia is becoming increasingly difficult; to speed revision any time a problem arises, the revision committees may seek advice from the numerous experts of the pharmaceutical industry thus achieving a most profitable collaboration.
The last 30 years have seen profound changes in the organisation of the European people and the regulation of medicinal products. Thirty years ago, each country had its own regulations, with all the possible variations between the various national pharmacopoeias. Today, the European Pharmacopoeia, with its 1500 monographs and nearly 250 general methods of analysis, has replaced the major part of these national regulations: the European Pharmacopoeia Convention has now been signed by 27 states(1) and by the Commission of the European Communities; moreover 16 European and non-European countries(2) and the WHO have observer status. Close relations are maintained with the licensing authorities of the European Economic Area, where integration is developing via the implementation of common directives and guidelines on medicines for human and veterinary use. In addition, in 1990, the European Pharmacopoeia co-founded, with the Japanese Pharmacopoeia and the US Pharmacopoeia, the Pharmacopoeial Discussion Group (PDG); this group is working assiduously for harmonisation at world level.