United Kingdom pharmaceutical production

Chloroform was used chiefly as an anesthetic and in pharmaceutical preparations immediately prior to World War II. However, these uses have been banned. Annual output in both the United States and the United Kingdom was between 900 and 1350 metric tons. During the war, chloroform production in the United States tripled, largely to meet the requirement for penicillin manufacture. Demand for chloroform continued to increase in the postwar period as its technical appHcations were extended. Consumption continues to increase at a comparatively rapid rate. Chloroform is now used primarily in the manufacture of HCFC-22, monochlorodifluoromethane, a refrigerant, and as a raw material for polytetrafluoroethylene plastics. 

The EU has approved Council Directive No. 92/28/EEClO (of 31 March 1992, now consolidated as Articles 86 to 100 of Directive 2001/83/EC) on the advertising of medicinal products for human use, thus bringing Member States into line with common requirements and standards. The UK regulations have been amended to comply with the Directive. The Directive, Part IV of the UK Medicines Act 1968 as amended by the Advertising Regulations, and the ABPl Code of Practice for the Pharmaceutical Industry are broadly in line with one another. The commentary below on promotion relates primarily to the United Kingdom. While there have been some moves towards the international harmonisation of controls on promotion, these have had only a limited effect, despite the fact that in Europe, Member States all comply with Directive 92/28. 

Applicants are free to solicit advice from individual Member States and according to various surveys conducted by the European Federation of Pharmaceutical Industries and Associations, they often do. Apart from the FDA, these surveys reveal, the EU Member States most often consulted are Germany, France, Sweden and the United Kingdom. Flowever, it is often important to secure a pan-European advice. Article 51 of Council Regulation EEC/2309/93 requires the EMEA to provide the Member States and the institutions of the Commimity with the best possible scientific advice on any question relating to the evaluation of the quality, the safety and the efficacy of medicinal products for human... 

The applications for national authorisations are submitted to the national competent authority which, in the United Kingdom, is the Licensing Authority (LA), whose functions are discharged by the Medicines and Healthcare products Regulatory Agency (MHRA, previously Medicines Control Agency, MCA) of the Department of Health. The LA/MHRA are advised by the CSM, a multidisciplinary scientific body consisting of clinical, preclinical and pharmaceutical members well known for their expertise in their respective fields. Lay members are also included. 

Each Member State of the European Union operates its own policy regarding the pricing of pharmaceutical products. In the United Kingdom, the primary tool is the Pharmaceutical Price Regulation Scheme (PPRS), which is better described as a profit-regulating scheme. This is dealt with in detail in Chapter 26. 

Bennett, B., and Cole, G., Eds. (2003), Pharmaceutical Production. An Engineering Guide, Institution of Chemical Engineers (IChemE), Rugby, Warwickshire, United Kingdom. 

Instrumented tablet presses with computer interfaces allow the pharmaceutical scientist to study the mechanism of compaction and the relationship of the mechanism to tablet-compaction properties and formulations. In addition, automated systems are useful to develop compression profiles for reference purposes, to control weight of tablets during development and production, and to monitor punch wear. This automation reduces the burden on personnel faced with the requirements of quality control. Merck Sharp and Dohme s major production facility in the United Kingdom is fully computerized to manufacture a high-volume tablet product as well as multiple-tablet products. " ... 

The first recorded reference to the use of expert systems in pharmaceutical product formulation was by Bradshaw on the April 27,1989, in the London Financial Times, closely followed by an article in the autumn of the same year by Walko. Both refer to the work then being undertaken by personnel at ICI/Zeneca Pharmaceuticals (now AstraZeneca), United Kingdom (UK) and Logica UK Ltd. to develop expert systems for formulating pharmaceuticals using Formulogic. Since that time, several companies and academic institutions have reported on their experiences in this area (Table 1). This article will review these applications. 

The PMPRB compares prices in Canada with those in seven industrialized nations (France, Germany, Italy, Sweden, Switzerland, the United Kingdom, and the United States) to ensure that Canadian prices are in line with those of comparable countries. There is some controversy that existing drug products are well-controlled regarding prices, but that such is not the case with newly introduced pharmaceuticals. 

There is a fast lane for new drug approvals if the product is already in at least one of the following jurisdictions the United Kingdom, Canada, United States, Sweden, or Australia. Approxmately 85% (by value) of pharmaceuticals go through the nearly 3,000 community pharmacies. Yet, approxmately 80% of the population rely on the public sector for drugs, received through clinics, hospitals, primary care posts, or military facilities. Although there is a 20-year patent period of exclusivity/protection, the parallel imports option effectively defeats this protection. 

Wehrli (1997) stated case reports from Australia, the United States and the United Kingdom and the activities of the Pharmaceutical Security Institute (PSl), which was founded by the majority of ethical pharmaceutical companies and operates under the auspices of the International Federation of Pharmaceutical Manufacturers Association (IFPMA). Wehrli further indicated that an API may be counterfeited in one country, passed by a circuitous route into another for formulation, from there to a third country where the product is sold. 

Jose Santos earned his doctorate in medicine from the Classic University of Lisbon in 1984. He has been a Clinical Research Associate at Lab. Servier and Associate Medical Director at Lab. Pfizer. Since 1992, Dr. Santos has been Medical Director at OM Portuguesa, S.A. He has also been serving ad Medical Rapporteur in the Commission of Revision of Pharmaceutical Products (CREF of the National Institute of Pharmacy and Medicines (INFARMED) since 1995. He is a member of the Portuguese Medical Association of the Pharmaceutical Industry and the Ordem dos Medicos and is a faculty member in pharmaceutical medicine at the Royal College of Physicians in the United Kingdom. 

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