Discovery & Approval
DRUG
Regulatory authorities need to perform the watchdog role to ensure that animal studies comply with Good Laboratory Practice (GLP), clinical trials are performed in accordance with Good Clinical Practice (GCP) and drugs are manufactured under current Good Manufacturing Practice (cGMP) conditions.
Safe
effective
The regulatory authorities generate regulations and guidelines for pharmaceutical compainies in order to obtain a balance between the theperapeutics advantages and the potential risk to patients. (Hill, R., & Rang, H. P, 2013)
Everyone want the drug being prescribed to be
SAFE
and
EFFECTIVE !!
Regulatory Authorities
Reference
1. Hill, R., & Rang, H. P. (2013). Drug discovery and development : Technology in transition (2nd ed.). Edinburgh ; New York: Elsevier.
2. ICH, 2015, 'Vision' ICH, available from, http://www.ich.org/about/vision.html
OMG!
That's scary
OMG!
That's scary
Vioxx is considered to be the largest drug recall in history, and one which elicited one of the greatest public outcries. Vioxx, prescribed to more than 20 million people as a pain reliever for arthritis, was found to be responsible for increased risk of heart attack and stroke. Both Merck and the FDA were roundly criticized for ignoring evidence of the dangers of Vioxx before its eventual recall in 2004, after 5 years being on the market. The Lancet reported that as many as 140,000 people could have suffered from serious coronary heart disease from taking the drug in the US alone. Merck settled Vioxx litigation in the US for $4.8 billion, with close to $1 billion in legal expenses. (EDT,2010)
Rofecoxib (vioxx)
Vioxx is considered to be the largest drug recall in history, and one which elicited one of the greatest public outcries. Vioxx, prescribed to more than 20 million people as a pain reliever for arthritis, was found to be responsible for increased risk of heart attack and stroke. Both Merck and the FDA were roundly criticized for ignoring evidence of the dangers of Vioxx before its eventual recall in 2004, after 5 years being on the market. The Lancet reported that as many as 140,000 people could have suffered from serious coronary heart disease from taking the drug in the US alone. Merck settled Vioxx litigation in the US for $4.8 billion, with close to $1 billion in legal expenses. (EDT,2010)
TErfendine (seldane)
Seldane was a popular antihistamine brought to market in 1985 to treat allergies without causing drowsiness. The FDA sought a recall in 1997(after 13 years being on the market) from the manufacturer, Hoechst (known as Aventis now) after cases of cardiac arrhythmia (abnormal electrical activity in the heart) appeared in patients taking Seldane with other drugs. The recall is notable mostly for its scale; more than 100 million patients worldwide used Terfenandine as of 1990. Seldane was a big moneymaker for Hoechst for a long periods (the year before it was pulled from the market, it sold $440 million worth of Terfenadine worldwilde) (EDT,2010)
BECAUSE,
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Harm to consumers
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Destroyed reputation
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Huge expenses
Communication, logistics, refunds, destruction, replacements, loss of sales and market, legal costs, compensation etc…
Recalls are disasters!!!!!!
A recall is when a product is removed from the market or a correction is made to the product because it is either defective or potentially harmful. (FDA, 2015)
Every countries have their own regulatory authorities. In this website, only US, Europe, Australia,
and Japan regulatory authorities are discussed as well as world regulatory bodies such as ICH and WHO. All the regulatory processes are complexed and lengthly. Therefore, this website only provides brief introduction and some background knowledge associated to their corresponding laws and guidelines. Besides, in this website, all the laws and guidelines required for developing a drug are mainly based on US unless otherwise stated.
EMA
European Medicines Agency
FDA
Food and Drug Administration
TGA
Therapeutic Goods Administration
MHLW
Ministry of Health, Labor, and Welfare
Although all the countries have their own regulatory authorities, the regulatory requirments are shown to be harmonized. ICH, International Conference on Harmonization, launched in 1990, aims to "to make recommendations towards achieving greater harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration, thereby reducing or obviating duplication of testing carried out during the research and development of new human medicines." (ICH, 2015)
ICH
International Conference on Harmonization
WHO
World Health Organization
The World Health Organization (WHO) is a specialized agency of the United Nations. WHO is not a regulatory agency; it is aims for:
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'To give worldwide guidance in the field of health'.
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'To set global standards for health'.
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'To cooperate with governments in strengthening national health programs'.
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'To develop and transfer appropriate health technology, information and standards'.