Sukesh Bhardwaj et al. / AJPSR volume 1 issue 5, Oct. 2011 1 Sukesh Bhardwaj et al. / AJPSR volume 1 issue 5, Oct 2011 Available online at www.ordonearresearchlibrary.com ISSN 2249-4898 ASIAN JOURNAL OF PHARMACEUTICAL SCIENCES AND RESEARCH COMPARATIVE STUDY: REQUIREMENTS FOR THE SUBMISSION OF GENERIC DRUG APPLICATION ACROSS US AND EU IN CTD/ECTD FORMAT Sukesh Bhardwaj, Vikaas Budhwar, Vipul K. Gupta Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak (Haryana). Received: 27 Aug. 2011; Revised: 24 Sep. 2011; Accepted: 21 Oct 2011; Available online: 25 Nov 2011 INTRODUCTION Food Drug and administration [1] is the regulatory agency of the United States and the European Union consists of about 27 countries, each nation has its own regulatory agency but EMEA 2 is the centralized regulatory authority applicable to whole Europe. In order to get the approval of the drug product in the particular country by their regulatory authorities, complex procedures had been followed. In Europe, there are three procedures mainly used for filing a drug application, such as, Centralized, decentralized/MRP and National Procedures 3 . There were lots of problems occur for the translation according to the regional language of a same application and are generally very time consuming process. To overcome such problems, a concept of ICH 4 was declared in 1990. This was declared by the cooperation of the three regions US, EU and Japan; which are known as tripartite regions of the ICH. ICH was organized with a major objective to draft, approve and implementation of the guidelines which are accepted throughout the tripartite regions. Such guidelines are made covering all the aspects and parameters related to the drug products i.e. purity, quality, safety, and efficacy point of view. Hence, the guidelines prepared by the ICH are known as tripartite guidelines. According to ICH, all the technical requirements for the application of drug approval were harmonized in CTD format which are scientifically more elaborate by USFDA in Quality Overall Summary (QOS) and Overall efficacy (includes clinical overview and clinical summary). This way of presentation of the registration documents has increased Review Article ABSTRACT The major pharmaceutical markets in the world are United States and European Union, have different requirements for the registration of a pharmaceutical product. To harmonize the requirements as per the regulatory agencies, a concept of common technical and its electric version was implemented by ICH. As the CTD consists 5 modules; some modules are common to all regions. But there are still some differences in the requirements in the common modules as per the regional requirements. In this competitive world of Pharma generics, an attempt is made to highlight the difference between the two major countries registration requirements through CTD and eCTD format in this article. Key words: CTD, eCTD, ANDA, Generic drugs etc.
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Sukesh Bhardwaj et al. / AJPSR volume 1 issue 5, Oct 2011
Available online at www.ordonearresearchlibrary.com ISSN 2249-4898
ASIAN JOURNAL OF PHARMACEUTICAL SCIENCES AND RESEARCH
COMPARATIVE STUDY: REQUIREMENTS FOR THE SUBMISSION OF GENERIC DRUG
APPLICATION ACROSS US AND EU IN CTD/ECTD FORMAT
Sukesh Bhardwaj, Vikaas Budhwar, Vipul K. Gupta Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak (Haryana).
Received: 27 Aug. 2011; Revised: 24 Sep. 2011; Accepted: 21 Oct 2011; Available online: 25 Nov 2011
INTRODUCTION Food Drug and administration [1] is the regulatory agency of the United States and the European Union consists
of about 27 countries, each nation has its own regulatory agency but EMEA2 is the centralized regulatory
authority applicable to whole Europe. In order to get the approval of the drug product in the particular country
by their regulatory authorities, complex procedures had been followed. In Europe, there are three procedures
mainly used for filing a drug application, such as, Centralized, decentralized/MRP and National Procedures3.
There were lots of problems occur for the translation according to the regional language of a same application
and are generally very time consuming process. To overcome such problems, a concept of ICH4 was declared in
1990. This was declared by the cooperation of the three regions US, EU and Japan; which are known as
tripartite regions of the ICH. ICH was organized with a major objective to draft, approve and implementation of
the guidelines which are accepted throughout the tripartite regions. Such guidelines are made covering all the
aspects and parameters related to the drug products i.e. purity, quality, safety, and efficacy point of view.
Hence, the guidelines prepared by the ICH are known as tripartite guidelines. According to ICH, all the
technical requirements for the application of drug approval were harmonized in CTD format which are
scientifically more elaborate by USFDA in Quality Overall Summary (QOS) and Overall efficacy (includes
clinical overview and clinical summary). This way of presentation of the registration documents has increased
Review Article
ABSTRACT The major pharmaceutical markets in the world are United States and European Union, have different requirements for the registration of a pharmaceutical product. To harmonize the requirements as per the regulatory agencies, a concept of common technical and its electric version was implemented by ICH. As the CTD consists 5 modules; some modules are common to all regions. But there are still some differences in the requirements in the common modules as per the regional requirements. In this competitive world of Pharma generics, an attempt is made to highlight the difference between the two major countries registration requirements through CTD and eCTD format in this article. Key words: CTD, eCTD, ANDA, Generic drugs etc.