International Medicinal Products

The WHO has set up the International Medicinal Products Anti-Counterfeiting Taskforce (IMPACT) with all 193 member states to combat counterfeit drugs. Five key areas were identified ... 

IMPACT International Medicinal Products Anti-Counterfeiting... 

The overall objective of clinical trials is to establish a drug therapy that is safe and effective in humans, to the extent that the risk-benefit relationship is acceptable. The ICH process has developed an internationally accepted definition of a clinical trial as Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy. ... 

The innovative pharmaceutical industry is one of the clearest exponents of the familiar process of the globalization of the economy. The reasons for this are obvious first, companies need to recover the huge investment in R D that is necessary to get an innovative medicinal product with added therapeutic value onto the market. Second, the cost of transporting pharmaceuticals is usually low in comparison with the economic value of the product, which facilitates the geographical extension of markets. Finally, the company does not even need to transport goods, as it can limit itself to selling technology, especially if the innovation is protected by a system of patents, and this facilitates international expansion even more. 

EU (2001) EU directive 2001/83/EC. http //eur-lex.europa.eu/LexUriServ/site/en/consleg/2001/L/ 02001L0083-20070126-en.pdf. Cited 30 Dec 2008 EMEA (2008) European Medicines Agency. EPARs for authorised medicinal products for human use. http //www.emea.europa.eu/htms/human/epar/a.htm. Cited 30 Dec 2008 ICH (2008) The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). http //www.ich.org. Cited 30 Dec 2008 ISMP (2005) The Institute for Safe Medication Practices. List of confused drug names. http //www.ismp.org/Tools/confuseddrugnames.pdf. Cited 30 Dec 2008... 

FDA International Conference on Harmonization Guideline on detection of toxicity to reproduction for medicinal products. Federal Register, September 22, 1994, Vol. 59, No. 183. 

Ancient papyrus provided written records of early Egyptian medical knowledge. The Ebers papyrus (from around 3000 bc) provided 877 prescriptions and recipes for internal medicine, eye and skin problems, and gynecology. Another record, from the Kahun papyrus of around ISOObc, detailed treatments for gynecological problems. Medications were based mainly on herbal products such as myrrh, frankincense, castor oil, fennel, sienna, thyme, linseed, aloe, and garlic. 

It would be wrong to give the impression that the PAT initiative is confined to the FDA. The FDA has increased its collaboration with international health and regulatory partners, including the International Conference on Harmonisation for the Technical Requirements for Registration of Pharmaceuticals (ICH) and the International Cooperation on Harmonisation of Technical Requirements for Veterinary Medicinal Products (VICH). 

Placebo-controlled trial of a new active medicinal product, if positive, means that the trial was capable of detecting a difference, and that the test treatment is, at least, more efficacious than placebo. This achieves two outcomes provision of an internal validity check of the trial methods, and provision to regulatory authorities of a basis on which to judge the difference between a statistically significant but clinically inadequate effect that would probably lead to the drug not being licensed. 

International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). Topic E8 Note for Guidance on General Considerations for Clinical Trials, CPMP/ICH/291/95. London European Agency for the Evaluation of Medicinal Products, 1997. 

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. 

Under Directive 2004/27/EC, there are various changes to the information to be included on the product label and certain provisions relating to the product s package leaflet. There is also a new requirement for the name of the medicinal product to be expressed in Braille format on the label. For products containing up to three active substances, the legislation specifies that the international non-proprietary name (INN) must also appear on the labelling. The MAH must also ensure that the package leaflet is made... 

Manufacturing sites within Australia must comply with the Australian Code of GMP for Medicinal Products - August 2002, which is based entirely on the international standard Guide to Good Manufacturing Practices for Medicinal Products, Version PHl/97 (Rev.3) 15 January 2002, published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S). The ICH GMP Guide for Active Pharmaceutical Ingredients has also been adopted. 

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