Medicine and medical products

Table 13.3 List of authorized medicinal and medical products containing dimethicone or simethicone.

The number of products registered with the TGA is approximately 60 000 items (including prescription drugs, OTC medicines, complementary medicines and medical devices). Only approximate data for human pharmaceutical products are shown here. 

In this, the fifth edition of this textbook, the title of the present chapter has been changed to The Safety of Medical Products in order to include devices which are now included in the remit of the Medicines and Healthcare Products Regulatory Agency (MHRA). It has also been decided to revise the chapter so as to reflect more closely the current needs of the pharmaceutical physician whose experience may have been entirely in the field of clinical medicine. 

On the 12 September 2002, the Health Minister, Lord Philip Hunt announced that the MCA and the Medical Devices Agency (MDA) would merge with effect from 1 April 2003. The merged agency would be known as the Medicines and Healthcare products Regulatory Agency (MHRA). 

Taken together, these provisions are intended to ensure that where doubt exists over whether a product - those on the Ijorderline between, for example, medicines and medical devices, medicines and cosmetics, medicines and food supplements, etc., - should be regulated under medicines or other sectoral legislation, the stricter medicines regulatory regime should apply. 

The term therapeutic goods includes prescription medicines, non-prescription medicines, complementary medicines and medical devices. The TGA also develops and implements national policies and controls for chemicals, gene technology, blood and blood products. 

Attention is drawn to the Guidelines for Company Sponsored Safety Assessment of Marketed Medicines (SAMM) which have been produced jointly by the ABPI, the British Medical Association, the Committee on Safety of Medicines, the Medicines and Healthcare products Regulatory Agency and the Royal College of General Practitioners. These state that SAMM studies should not be undertaken for the purposes of promotion. 

Companies must prepare detailed briefing material for medical representatives on the technical aspects of each medicine which they will promote. A copy of such material must be made available to the Medicines and Healthcare products Regulatory Agency and the Prescription Medicines Code of Practice Authority on request. Briefing material must comply with the relevant requirements of the Code and, in particular, is subject to the certification requirements of Clause 14. 

Copies of the published reports are sent to the Medicines and Healthcare products Regulatory Agency, the Office of Fair Trading, the British Medical Association, the Royal Pharmaceutical Society of Great Britain and the Editors of the BMJ and The Pharmaceutical Journal. Copies of the published reports are also available to anyone on request. 

The views of the Prescription Medicines Code of Practice Authority and the Code of Practice Appeal Board must be sought on any proposal to amend the Code or this Constitution and Procedure. The views of the Medicines and Healthcare products Regulatory Agency, the British Medical Association and the Royal Pharmaceutical... 

Drugs.com. Drug Information Online. Available online. URL http // www.drugs.com. Downloaded June 16, 2009. Self-identified as a free, accurate, and independent source of information on 24,000 prescription drugs, OTC medicines, and natural products, this Web site does indeed contain an enormous amount of information on prescription drugs. The descriptions of drugs are clearly written and detailed, and daily medical news stories and pharmaceutical industry news offer added information. Without a specific topic or question of interest, however, the sheer amount of information makes the material overwhelming. 

The FDA is an agency within the PHS, which in turn is a part of the DHHS. The FDA regulates over 1 trillion worth of products, which account for 25 cents of every dollar spent annually by American consumers. The FDA touches the lives of virtually every American, every day, for it is FDA s job to see that the food we eat is safe and wholesome, the cosmetics we use will not harm us, the medicines and medical devices we use are safe and effective, and radiation-emitting products such as microwave ovens will not cause harm. Feed and drugs for pets and farm animals also come under FDA scrutiny. The FDA also ensures that all of these products are labeled truthfully with the information people need to use them properly. 

European medical device requirements are defined in EU Directive 93/42/EEC published in 1994. National legislation and regulatory authorities such as the U.K. Medicines and Healthcare products Regulatory Authority (MHRA) enforce this directive. Four classes of device are defined, each of which requires a visible CE marking of conformity. CE marking of conformity means that the manufacturer is satisfied that the medical device conforms to relevant EU Directives and that it is fit for purpose. Technical documentation supporting conformity related to automated devices includes ... 

The role of Medsafe in ensuring the safe and effective use of therapeutic products is encapsulated by its mission statement Healthy New Zealanders, by regulating medicines and medical devices to maximise safety and benefit. As a small agency with limited resources, Medscife generally applies a risk assessment-based approach to regulatory control, in order to maximise the benefit risk equation for therapeutic products. 

The Compliance Team monitors overall compliance with the legislation relating to therapeutic products in New Zealand. The team conducts various activities in order to minimise the risk to the public from the use of medicines and medical devices and to ensure the integrity of the manufacture and distribution chain for medicines. This is conducted by staff in the Wellington office and by Medicines Control Advisors based in each of the five Regional Licensing Offices. 

The new Reg. 726/2004 now makes the authorisation procedure compulsory for orphan medicinal products and medical products for human use containing an entirely new active substance for the treatment of AIDS, cancer, neurodegenerative disorder or diabetes. See Annex to Regulation listing all products now requiring Community authorisation and those needing it as of 2008. 

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