ISSN
2277 - 3282
e ISSN
2277 - 3290
Publisher
Journal of Science
STUDY ON THE REGULATORY REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE IN COMMON WEALTH OF INDEPENDENT STATES
Author / Afflication
Praneetha K
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati - 517506, Andhra Pradesh, India.
Prakash B
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati - 517506, Andhra Pradesh, India.
Umasankar K
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati - 517506, Andhra Pradesh, India.
Alagusundaram M
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati - 517506, Andhra Pradesh, India.
Jayachandra Reddy P
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati - 517506, Andhra Pradesh, India.
Keywords
CTD-Common Technical Document ,ASEAN CTD , Non-CTD , CIS countries ,
Abstract
Dossier is a file document submitted based on the requirement of the drug approval process. It is a comprehensive scientific document used to obtained worldwide licensing approval of a drug by diverse health authorities. There are different requirements in different countries for registration of a product. Regulatory agencies require Pharmaceutical Dossiers to gain approval to market drugs. Dossier is a document file which has technical and administrative information. Pharma companies prepare dossier as per CTD / ASEAN CTD / non-CTD (country specific guideline).CIS countries follow their own country specific dossier format.
Volume / Issue / Year
4 , 8 , 2014
Starting Page No / Endling Page No
486 - 504