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

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