TY - BOOK PY - 2014 DA - 2014// TI - Guidance for industry ANDA submissions — content and format of abbreviated new drug applications, ed. Rockville, USA ID - ref1 ER - TY - BOOK PY - 2014 DA - 2014// TI - First ed. Selangor Darul Ehsan, Malaysia National Pharmaceutical Control Bureau Ministry of Health, Malaysia ID - ref2 ER - TY - CHAP PY - 2011 DA - 2011// TI - Guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format BT - WHO expert committee on specifications for pharmaceutical preparations. Annex 5 (WHO technical report series, No. 961) ID - ref3 ER - TY - STD TI - European Medicines Agency. Guideline on the investigation of bioequivalence secondary guideline on the investigation of bioequivalence. 2010. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf. Accessed 15 June 2015. UR - http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf ID - ref4 ER - TY - JOUR AU - Polli, J. E. PY - 2008 DA - 2008// TI - In vitro studies are sometimes better than conventional human pharmacokinetic in vivo studies in assessing bioequivalence of immediate-release solid oral dosage forms JO - AAPS J VL - 10 UR - https://doi.org/10.1208/s12248-008-9027-6 DO - 10.1208/s12248-008-9027-6 ID - Polli2008 ER - TY - BOOK PY - 2015 DA - 2015// TI - Guidance for industry: waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. Rockville, USA ID - ref6 ER - TY - BOOK PY - 2014 DA - 2014// TI - Guidance document: biopharmaceutics classification system based biowaiver PB - Health Products and Food Branch, Health Canada CY - Ottawa ID - ref7 ER - TY - STD TI - Health Sciences Authority Singapore. Guidance on medicinal product registration in Singapore. 2011. http://www.hsa.gov.sg/content/hsa/en.html. Accessed 1 June 2015. UR - http://www.hsa.gov.sg/content/hsa/en.html ID - ref8 ER - TY - BOOK AU - Hill, S. AU - Johnson, K. PY - 2004 DA - 2004// TI - Emerging challenges and opportunities in drug registration and regulation in developing countries. Access to medicines PB - Fretwells Ltd CY - London ID - Hill2004 ER - TY - BOOK PY - 2016 DA - 2016// TI - Legislation: National Medicines Regulatory Authority Act, no. 5 of 2015 Colombo, Sri Lanka ID - ref10 ER - TY - BOOK AU - Fund, T. G. PY - 2018 DA - 2018// TI - Quality assurance policy for pharmaceutical products ID - Fund2018 ER - TY - BOOK AU - Thambawita, D. AU - Mannapperuma, U. AU - Galappatthy, P. AU - Dissanayeke, S. AU - Benaragama, B. V. S. H. AU - Jayakody, R. L. PY - 2015 DA - 2015// TI - Compliance of selected drug dossiers submitted for registration, as per drug regulatory authority requirements and WHO recommendations. Proceedings of international medical congress, Sri Lanka medical association ID - Thambawita2015 ER - TY - BOOK AU - Wharf, C. PY - 2016 DA - 2016// TI - EMA procedural advice for users of the centralised procedure for generic/hybrid applications ID - Wharf2016 ER - TY - STD TI - United States Food and Drug Administration. What are generic drugs?. 2015. https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/default.htm. Accesssed 01 July 2016. UR - https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/default.htm ID - ref14 ER - TY - BOOK PY - 2012 DA - 2012// TI - Generic medicines ID - ref15 ER - TY - BOOK PY - 2013 DA - 2013// TI - Guidance on Biopharmaceutics Classification System (BCS) based biowaiver PB - Ministry of Health Malaysia CY - Malaysia ID - ref16 ER - TY - BOOK PY - 2012 DA - 2012// TI - Approval review of generic drugs in Japan. Second international generic drug regulators meeting ID - ref17 ER - TY - BOOK PY - 2016 DA - 2016// TI - Approval process ID - ref18 ER - TY - STD TI - Therapeutic Goods Administartion, Australia. Australian regulatory guideline for over-the-counter medicines. 2012.https://www.tga.gov.au/publication/australian-regulatory-guidelines-otc-medicines-argom. Accessed 2 Oct 2016. UR - https://www.tga.gov.au/publication/australian-regulatory-guidelines-otc-medicines-argom ID - ref19 ER - TY - BOOK PY - 2014 DA - 2014// TI - Common Technical Document (CTD) ID - ref20 ER - TY - BOOK PY - 2011 DA - 2011// TI - Draft guidance for industry:preparation of comparative bioavailability information for drug submissions in the CTD format ID - ref21 ER - TY - BOOK PY - 2008 DA - 2008// TI - Release of Health Canada’s revisions to “1.6 electronic review documents” in draft guidance for industry: preparation of new drug submissions in the CTD format ID - ref22 ER - TY - BOOK PY - 2004 DA - 2004// TI - ICH topic M 4, common technical document for the registration of pharmaceuticals for human use –organisation CTD secondary ICH topic M 4, common technical document for the registration of pharmaceuticals for human use –organisation CTD ID - ref23 ER - TY - CHAP PY - 2005 DA - 2005// TI - Guidance for industry on submission of clinical trial application for evaluating safety and efficacy BT - Ministry of Health ID - ref24 ER - TY - BOOK PY - 2010 DA - 2010// TI - Guidance for industry on preparation of common technical document for import/manufacture and marketing approval PB - Family Welfare Govt. of India CY - New Delhi ID - ref25 ER - TY - BOOK PY - 2015 DA - 2015// TI - CH-M4 CTD (common technical document) ID - ref26 ER - TY - BOOK PY - 2015 DA - 2015// TI - Guidance for industry: M4: organization of the CTD ID - ref27 ER - TY - STD TI - Ministry of Food and Drug Safety Republic of Korea. Guide to drug approval system in Korea. 2017.http://www.masung.co.kr/bbs/board.php?bo_table=s03_01_eng&wr_id=1. Accessed 10 June 2017. UR - http://www.masung.co.kr/bbs/board.php?bo_table=s03_01_eng&wr_id=1 ID - ref28 ER - TY - STD TI - National Pharmaceutical Bureau Ministry of Health Malaysia. Generic products containing drug substances/active pharmaceutical ingredients (api) that may be considered for biowaiver. 2014. http://npra.moh.gov.my/images/Guidelines_Central/Guidelines_on_Bioequivalence_BE/Guidance-on-BCS-Based-Biowaiver.pdf. Accessed 7 June 2016. UR - http://npra.moh.gov.my/images/Guidelines_Central/Guidelines_on_Bioequivalence_BE/Guidance-on-BCS-Based-Biowaiver.pdf ID - ref29 ER - TY - STD TI - Health Sciences Authority in Singapore. Guidance on medicinal product registration in Singapore. 2011. http://www.hsa.gov.sg/content/dam/HSA/HPRG/Western_Medicine/Overview_Framework_Policies/Guidelines_on_Drug_Registration/Updates%20for%20Guidance%20on%20Medicinal%20Product%20Regist. Accessed 15 June 2016. UR - http://www.hsa.gov.sg/content/dam/HSA/HPRG/Western_Medicine/Overview_Framework_Policies/Guidelines_on_Drug_Registration/Updates%20for%20Guidance%20on%20Medicinal%20Product%20Regist ID - ref30 ER - TY - STD TI - Cosmetics Devices and Drugs Regulatory Authorty. Application Forms. Secondary Application Forms. http://nmra.gov.lk/index.php?option=com_content&view=article&id=86&Itemid=84&lang=en. Accessed 5 May 2014. UR - http://nmra.gov.lk/index.php?option=com_content&view=article&id=86&Itemid=84&lang=en ID - ref31 ER - TY - STD TI - Thambavita D, Galappatthy P, Jayakody R. Requirement for bioequivalence and biowaiver data for regulatory decision making: a comparative study of regulatory authorities. Proceeding of the annual scientific session of the Sri Lanka Association of Clinical Pharmacology and Therapeutics Colombo, Sri Lanka: Sri Lanka Association of Clinical Pharmacology and Therapeutics. 2016. p. 24. ID - ref32 ER - TY - BOOK AU - Melchior, R. PY - 2011 DA - 2011// TI - How transparent are regulatory agencies with regard to review timelines? A global review PB - Thomson Reuters France CY - Chicago ID - Melchior2011 ER - TY - BOOK PY - 2015 DA - 2015// TI - FDA/GPhA quarterly meeting on GDUFA ID - ref34 ER - TY - JOUR AU - Kuribayashi, R. AU - Matsuhama, M. AU - Mikami, K. PY - 2015 DA - 2015// TI - Regulation of generic drugs in Japan: the current situation and future prospects JO - AAPS J VL - 17 UR - https://doi.org/10.1208/s12248-015-9777-x DO - 10.1208/s12248-015-9777-x ID - Kuribayashi2015 ER - TY - BOOK PY - 2015 DA - 2015// TI - Quality guidelines ID - ref36 ER - TY - BOOK PY - 2001 DA - 2001// TI - The impact of implementation of ICH guidelines in non-ICH countries ID - ref37 ER - TY - BOOK AU - Ratanawijitrasin, S. AU - Wondemagegnehu, E. PY - 2002 DA - 2002// TI - Effective drug regulation a multicountry study PB - World Health Organization CY - Geneva ID - Ratanawijitrasin2002 ER - TY - BOOK AU - Martin, H. PY - 2010 DA - 2010// TI - Harmonization and standardization of the ASEAN medical industry. Council, US-ASEAN business ID - Martin2010 ER - TY - BOOK PY - 2011 DA - 2011// TI - Marketing authorization of pharmaceutical products with special reference to multisource (generic) products: a manual for drug regulatory authorities. 2 ed. Geneva Switzerland ID - ref40 ER - TY - JOUR AU - Davit, B. M. AU - Kanfer, I. AU - Tsang, Y. C. PY - 2016 DA - 2016// TI - BCS biowaivers: similarities and differences among EMA, FDA, and WHO requirements JO - AAPS J VL - 18 UR - https://doi.org/10.1208/s12248-016-9877-2 DO - 10.1208/s12248-016-9877-2 ID - Davit2016 ER - TY - BOOK PY - 2016 DA - 2016// TI - Guideline on quality of oral modified release products ID - ref42 ER - TY - JOUR AU - Kashyap, U. N. AU - Gupta, V. AU - Raghunandan, H. PY - 2013 DA - 2013// TI - Comparison of drug approval process in United States & Europe JO - J Pharm Sci Res VL - 5 ID - Kashyap2013 ER - TY - JOUR AU - Hirako, M. AU - McAuslane, N. AU - Salek, S. PY - 2007 DA - 2007// TI - A comparison of the drug review process at five international regulatory agencies JO - Drug Inf J VL - 41 UR - https://doi.org/10.1177/009286150704100302 DO - 10.1177/009286150704100302 ID - Hirako2007 ER - TY - BOOK AU - Galappatthy, P. AU - Mythily, S. AU - Wickramarathna, T. N. PY - 2016 DA - 2016// TI - Availability, prices and registration status of the most commonly prescribed medicines in private pharmacies in Sri Lanka: an island wide survey. Proceedings of the Sri Lanka Association of Clinical Pharmacology and Therapeutics PB - Sri Lanka Association of Clinical Pharmacology and Therapeutics CY - Colombo ID - Galappatthy2016 ER - TY - BOOK PY - 2001 DA - 2001// TI - Note for guidance on the investigation of bioavailability and bioequivalence ID - ref46 ER - TY - STD TI - United States Food and Drug Administration. Guidance for industry- waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. 2000. https://www.fda.gov/downloads/Drugs/Guidances/ucm070246.pdf. Accessed 20 Sept 2016. UR - https://www.fda.gov/downloads/Drugs/Guidances/ucm070246.pdf ID - ref47 ER - TY - BOOK PY - 2013 DA - 2013// TI - CFR-code of Federal Regulations-Bioavailability and bioequivalence requirements ID - ref48 ER - TY - JOUR AU - Anand, K. AU - Mallu, U. R. AU - Kuraku, M. PY - 2013 DA - 2013// TI - Pharmaceutical drug products approval procedure in Australia JO - Exp VL - 11 ID - Anand2013 ER - TY - CHAP PY - 2013 DA - 2013// TI - Guidance for industry-Management of Drug Submissions BT - Therapeutic products directorate PB - Minister of Public Works and Government Services Canada CY - Ontario ID - ref50 ER - TY - BOOK PY - 2016 DA - 2016// TI - The centralised procedure at the EMA. Secondary the centralised procedure at the EMA ID - ref51 ER - TY - BOOK PY - 2016 DA - 2016// TI - Pharmaceutical and API product registration in the other Asian countries ID - ref52 ER - TY - BOOK PY - 2014 DA - 2014// TI - CDSCO Timelines ID - ref53 ER -