WORLD TRADE G/TBT/Notif.97.765
31December 1997
ORGANIZATION
(97-1938)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: CANADA
Ifapplicable, name oflocalgovernment involved (Articles 3.2and7.2):
2. Agency responsible: Department ofHealth
Agency orauthority designated tohandle comments regarding thenotification shall be
indicated ifdifferent from above: National Enquiry Point
3. Notified under Article 2.9.2 [X],2.10.1 [],5.6.2 [],5.7.1 [],other:
4. Products covered (HSorCCCN where applicable, otherwise national tariff heading.
ICSnumbers maybeprovided inaddition, where applicable): Conjugated estrogens
5. Title, number ofpages andlanguage(s) ofthenotified document: Proposed Amendment
totheFood andDrug Regulations (873) (pages 3693-3697)
6. Description ofcontent: Thisregulatory Amendment establishes anupdated standard for
conjugated estrogens inDivision 6oftheFood andDrug Regulations. Conjugated
estrogen preparations consist ofamixture ofnaturally occurring orsynthetically
produced estrogens. They areindicated fortherelief ofmenopausal symptoms andfor
theprevention ofosteoporosis which mayoccur altermenopause.
Astandard describes thespecifications towhich adrug must bemanufactured
andrepresented. TheFood andDrugs Actrequires thatadrug meet oneofthe
following three types ofstandards: astandard prescribed inregulation, acompendial
standard, oraprofessed standard.
Ifastandard isprescribed inregulation, thedrugmust meet thatstandard. The
Canadian Standard Drug (CSD) forconjugated estrogen substance waslastupdated in
1982. Itdiffered from theUSPStandard inrespect tothemethodology usedaswellas
therequirements tobemet. The1982 CSD wasestablished based onaminimum of
7.0percentofthelabelclaim forathirdcomponent, sodium 17a-dihydroequilin sulfate.
Gaschromatography wastheanalytical method employed fortheidentification testing in
USPXX(1980) andfortheassay inUSPXIX(1985). Developments indruganalysis,
including capillary column gas chromatography and high-performance liquid
chromatography improved specificity, precision andaccuracy characteristics, thereby
outdating theoriginal colorimetric method described inthe1970 USP. USPXXIII
describes themethodology thatshould beusedtoday.
./.G/TBT/Notif.97.765
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6. Description ofcontent: (cont'd):
InCanada, genetic conjugated estrogen products have been approved andhave
been marketed since 1963. Review bytheTherapeutic Products Directorate ofthe
extensive market experience aswell asrecent scientific information supports the
establishment ofuniquely Canadian standard withCanadian specifications. Itisthis
standard which conjugated estrogen drug substances andconjugated estrogen drug
products must meetinorder togainapproval forsaleontotheCanadian market.
7. Objective andrationale, including thenature ofurgent problems where applicable:
Protection ofhuman health andsafety
8. Relevant documents: Canada Gazette, PartI,29November 1997
9. Proposed dateofadoption:
Proposed dateofentry intoforce:Notstated
10. Final dateforcomments: 10February 1998
11. Texts available from: National enquiry point [X]oraddress, e-mail andtelefax number
ofother body: