Australian Drug Categories - Revision history

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	The original Australian Drug Evaluation Committee (ADEC) formed in 1963 was replaced in 2010 by the ~~'''~~Advisory Committee on Prescription Medicines~~'''~~ (ACPM).		The original Australian Drug Evaluation Committee (ADEC) formed in 1963 was replaced in 2010 by the Advisory Committee on Prescription Medicines (ACPM), replaced in 2017 by the [[Australian_Drug_Categories#Advisory Committee on Medicines\|Advisory Committee on Medicines]] (ACM).

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	\|}		\|}

	==~~Australia -~~ Advisory Committee on ~~Prescription~~ Medicines==		==Advisory Committee on Medicines==

	~~The~~ Australian Drug Evaluation Committee (ADEC) was established in 1963 following the thalidomide experience ~~and in~~ 2010 ~~this~~ committee was replaced by the ~~[http://www.tga.gov.au/committee/acpm.htm~~ Advisory Committee on Prescription Medicines (ACPM)~~]. The new~~ ACPM ~~advises and makes recommendations to~~ the ~~Therapeutic Goods Administration (TGA)~~ on ~~prescription medicines listed on the Australian Register of Therapeutic Goods~~ (~~ARTG~~)~~, established under the Therapeutic Goods Act 1989. There were approximately 54,000 products on the Australian Register of Therapeutic Goods as at 23 May 2008~~.		* '''1963''' - Australian Drug Evaluation Committee (ADEC) was established in 1963 following the thalidomide experience.
			* '''2010''' - the ADEC committee was replaced by the Advisory Committee on Prescription Medicines (ACPM)
			* '''2017''' - ACPM committee was replaced by the Advisory Committee on Medicines (ACM).

	~~Advisory Committee on Prescription Medicines~~		:''The ACM provides independent medical and scientific advice to the Minister for Health and the Therapeutic Goods Administration (TGA) on issues relating to the safety, quality and efficacy of medicines supplied in Australia including issues relating to pre-market and post-market functions for medicines.''
	* inclusion of a prescription medicine on the ~~Australian Register of~~ Therapeutic Goods (~~the Register~~)
	* changes to ~~an entry of a prescription medicine on~~ the ~~Register~~
	* removal or retention of ~~a prescription medicine on the Register~~

			{{Australian Drug Categories}}

			{{Drug Testing table}}

	:'''Links:''' [~~http~~://www.tga.gov.au/committee/~~acpm.htm~~ Advisory Committee on ~~Prescription~~ Medicines]
			:'''Links:''' [https://www.tga.gov.au/committee/advisory-committee-medicines-acm Advisory Committee on Medicines]

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	==Prescribing Medicines in Pregnancy Database==		==Prescribing Medicines in Pregnancy Database==
			The TGA database must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases.

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	[[File:TGA_logo.jpg\|thumb\|Therapeutic Goods Administration logo.]]		[[File:TGA_logo.jpg\|thumb\|Therapeutic Goods Administration logo.]]
	Legal drugs are classified, usually by each country's appropriate regulatory body, on the safety of drugs during pregnancy. In Australia, the Therapeutic Goods Authority (TGA) has classes (A, B1, B2, B3, C, D and X) to define legal drugs safety.		Legal drugs are classified, usually by each country's appropriate regulatory body, on the safety of drugs during pregnancy. In Australia, the Therapeutic Goods Authority (TGA) has classes (A, B1, B2, B3, C, D and X) to define legal drugs safety.

			The Australian categorisation system differs from the [[USA Drug Categories\|US FDA categorisation]]. The categorisation of medicines for use in pregnancy does not follow a hierarchical structure.

			* Human data are lacking or inadequate for drugs in the B1, B2 and B3 categories
			* Subcategorisation of the B category is based on animal data
			* The allocation of a B category does not imply greater safety than a C category
			* Medicines in category D are not absolutely contraindicated during pregnancy (e.g.anticonvulsants)


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	:'''Examples:''' Misoprostol, Dienoestrol, Raloxifene, Finasteride, Ribavirin, Tretinoin (Oral), Isotretinoin, sodium phosphate P<sup>32</sup>		:'''Examples:''' Misoprostol, Dienoestrol, Raloxifene, Finasteride, Ribavirin, Tretinoin (Oral), Isotretinoin, sodium phosphate P<sup>32</sup>

			==Prescribing Medicines in Pregnancy Database==


			:'''Links:''' [https://www.tga.gov.au/prescribing-medicines-pregnancy-database#searchname Prescribing Medicines in Pregnancy Database]

	==Drug Testing==		==Drug Testing==
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	{{External Links}}		{{External Links}}
	* Australia [http://www.tga.gov.au/ Therapeutic Goods Authority]		* Australia [http://www.tga.gov.au/ Therapeutic Goods Authority]
			** [https://www.tga.gov.au/prescribing-medicines-pregnancy-database#searchname Prescribing Medicines in Pregnancy Database]
	** [http://www.tga.gov.au/about/committees-acpm.htm Advisory Committee on Prescription Medicines (ACPM)]		** [http://www.tga.gov.au/about/committees-acpm.htm Advisory Committee on Prescription Medicines (ACPM)]
	** [http://www.tga.gov.au/hp/medicines-pregnancy.htm Prescribing Medicines in Pregnancy]		** [http://www.tga.gov.au/hp/medicines-pregnancy.htm Prescribing Medicines in Pregnancy]
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	{{Footer}}		{{Footer}}

	[[Category:Abnormal Development]] [[Category:Environmental Abnormalities]] [[Category:Human Embryo]] [[Category:Human Fetus]]		[[Category:Abnormal Development]] [[Category:Environmental Abnormalities]] [[Category:Human Embryo]] [[Category:Human Fetus]]

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	* USA [http://toxnet.nlm.nih.gov/ TOXNET] - Databases on toxicology, hazardous chemicals, environmental health, and toxic releases. [http://toxnet.nlm.nih.gov/pda/ mobile]		* USA [http://toxnet.nlm.nih.gov/ TOXNET] - Databases on toxicology, hazardous chemicals, environmental health, and toxic releases. [http://toxnet.nlm.nih.gov/pda/ mobile]



			==Terms==

			{{Drug terms}}

	{{Glossary}}		{{Glossary}}

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	\| The Declaration of Helsinki was developed by The World Medical Association (WMA) as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The Declaration is intended to be read as a whole and each of its constituent paragraphs should not be applied without consideration of all other relevant paragraphs. It is widely regarded as the cornerstone document on human research ethics. It is named after the location of its initial adoption in Helsinki, Finland, in June 1964.		\| The Declaration of Helsinki was developed by The World Medical Association (WMA) as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The Declaration is intended to be read as a whole and each of its constituent paragraphs should not be applied without consideration of all other relevant paragraphs. It is widely regarded as the cornerstone document on human research ethics. It is named after the location of its initial adoption in Helsinki, Finland, in June 1964.
	\|}		\|}

			==Australia - Advisory Committee on Prescription Medicines==

			The Australian Drug Evaluation Committee (ADEC) was established in 1963 following the thalidomide experience and in 2010 this committee was replaced by the [http://www.tga.gov.au/committee/acpm.htm Advisory Committee on Prescription Medicines (ACPM)]. The new ACPM advises and makes recommendations to the Therapeutic Goods Administration (TGA) on prescription medicines listed on the Australian Register of Therapeutic Goods (ARTG), established under the Therapeutic Goods Act 1989. There were approximately 54,000 products on the Australian Register of Therapeutic Goods as at 23 May 2008.

			Advisory Committee on Prescription Medicines
			* inclusion of a prescription medicine on the Australian Register of Therapeutic Goods (the Register)
			* changes to an entry of a prescription medicine on the Register
			* removal or retention of a prescription medicine on the Register



			:'''Links:''' [http://www.tga.gov.au/committee/acpm.htm Advisory Committee on Prescription Medicines]

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	Typical testing of new drug compound today involves a lengthy series of animal and human studies.		Typical testing of new drug compound today involves a lengthy series of animal and human studies.

	~~'''~~Animal ~~studies'''~~		===Animal Studies===

	Usually tested in at least two mammalian species (rats and guinea pigs) using both single and repeated doses. For determining reproductive effects, tests on both male and female animals with dosing begins 4 weeks prior to mating are conducted to determine effects on fertility in both sexes, on embryogenesis, and on fetal malformation.		Usually tested in at least two mammalian species (rats and guinea pigs) using both single and repeated doses. For determining reproductive effects, tests on both male and female animals with dosing begins 4 weeks prior to mating are conducted to determine effects on fertility in both sexes, on embryogenesis, and on fetal malformation.

	~~'''~~Human Clinical ~~trials'''~~		===Human Clinical Trials===

	Following animal studies to determine dose, efficacy and apparent safety, human studies can commence. Clinical trials are carried out under very strict conditions, set by international regulatory bodies in agreement with the principles espoused in the Declaration of Helsinki. There are four phases to the trials.		Following animal studies to determine dose, efficacy and apparent safety, human studies can commence. Clinical trials are carried out under very strict conditions, set by international regulatory bodies in agreement with the principles espoused in the Declaration of Helsinki. There are four phases to the trials.

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	* '''Phase IV trials''' - (post-registration) conducted in 1000’s of patients over several years, these trials are randomised controlled trials undertaken after the drug has been registered.		* '''Phase IV trials''' - (post-registration) conducted in 1000’s of patients over several years, these trials are randomised controlled trials undertaken after the drug has been registered.

			===Government Regulatory Authorities===
	After phase I to III the pharmaceutical company compiles all study data for independent assessment by government regulatory authorities in each country:		After phase I to III the pharmaceutical company compiles all study data for independent assessment by government regulatory authorities in each country:
	* [~~http~~://www.~~fda~~.gov~~/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default~~.~~htm FDA~~] ~~in the USA, Therapeutic Goods Administration~~ ([~~https~~://www.~~tga~~.~~gov~~.~~au TGA~~]) ~~in Australia,~~ [http://www.medsafe.govt.nz Medsafe] in New Zealand, Medicines & Healthcare products		* Australia - Therapeutic Goods Administration ([https://www.tga.gov.au TGA])
	Regulatory Agency ([https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency MHRA]) ~~in the UK, and Health Products and Food Branch (~~[http://www.~~hc-sc~~.~~gc.ca~~/~~dhp-mps~~/~~prodpharma~~/~~activit~~/~~fs-fi/reviewfs_examenfd-eng~~.~~php HPFB~~]~~) in Canada.~~		* Canada - Health Products and Food Branch ([http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/fs-fi/reviewfs_examenfd-eng.php HPFB])
			* New Zealand - [http://www.medsafe.govt.nz Medsafe] in New Zealand
			* UK - Medicines & Healthcare products Regulatory Agency ([https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency MHRA])
			* USA - [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm FDA]

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	The drug examples given on this current page are not a comprehensive list within the drug classification, and are derived from '''Prescribing medicines in pregnancy'''.<ref>[http://www.tga.gov.au/docs/html/mip/medicine.htm Prescribing medicines in pregnancy, 4th edition]</ref>		The drug examples given on this current page are not a comprehensive list within the drug classification, and are derived from '''Prescribing medicines in pregnancy'''.<ref>[http://www.tga.gov.au/docs/html/mip/medicine.htm Prescribing medicines in pregnancy, 4th edition]</ref>


			This page also includes a brief generic description of current drug testing procedures.

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	{{Environmental}}		{{Environmental}}
	==Pregnancy Category==		==Pregnancy Category==
			{{Australian Drug Categories}}
	===Pregnancy Category A===		===Pregnancy Category A===
	Have been taken by a large number of pregnant women and women of childbearing age without an increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.		Have been taken by a large number of pregnant women and women of childbearing age without an increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.