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5.documents which describe FDA'S policy & regulatory approach to a specific area or issue
6.one of the key areas of ICH supported by pre-clincal trials
7.abbreviations for American organizationf that represents pharmaceutical Research companies and Manufacturers in the ICH
8.abbreviations for reference listed drugs
11.An amendment of a law in USA which lead to introduction of generic drugs(hint 2 words)
12.The Canadian regulation that helps sponsors to apply for an establishment licence
13.one of the key responsibilities of marketed health product directorate
15.Electronic Standards for transmission of Regulatory Information is abbreviated _______________
16.if an application to licence a drug fails to get a notice of compliannce it gets---------(hint 2 words)
18.Directives in Europe are incorporated into the laws of a member country by national legislation through an act of ______________
19.an amendment of USA law that created prescription and over the counter drug(hint 2 words)
1.The operational arm of JMHLW is _________
2.ICH guidelines starting with letter M are______________(hint 2 words)
3.abbreviations for an organization in USA which has the oversight for evaluation of medicines before they are licensed for sale
4.A bbreviations for the Japanese Organization representing the government in the ICH
6.enacted by a legislative body such as parliament or congress
9.a person who introduced an amendment in the USA law that drugs should be proven to be safe and effective before they are approved for sale
10.abbreviations for a canadian government organization responsible for compliance and law enforcement in the pharmaceutical industry
14.one of the ICH areas which deals with chemistry, manufacturing and specifications of the drug substance and drug product
17.one of the key areas of ICH supported by clincal trials

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