1. Abstract References Why CTD ? CTD is an ICH standard that FDA adopted in a consensus process, as a member of ICH, together with other member regions, Europe and Japan. It is currently global format for regulatory Submissions as it is a collection of electronic files organized according to guidelines defining file format, folder/files naming convention, document specifications etc. It Applies to all NDAs, ANDAs, BLAs, INDs and Master files. In July 2003, CTD became the mandatory format for new drug application in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to the FDA. It has been adopted by several other countries including Australia, Canada and Switzerland. CURRENT TRENDS IN REVIEW OF COMMON TECHNICAL DOCUMENT DOSSIER Ishpreet Kaur 1 *, Manu Babbar 2, Harsharan Pal Singh 3 1 Department of Quality Assurance, Delhi Institute of Pharmaceutical Sciences & Research, Pushp Vihar, New Delhi-110017 2 Canton Pharma Consultants, New Delhi 3 Department of Pharmacology, Noida Institute of Engineering & Technology, Greater Noida Email.id – ishpreet1992@gmail.com Electronic Common Technical Document (e-CTD) Electronic Common Technical Document (e-CTD) The ICH M2 EWG has defined the specification for electronic technical common document. e-CTD is composed of two types of specification, Content specification- As defined by ICH and Technical specification – Electronic software’s. e-CTD is highly recommended by USFDA for NDAs, BLAs, DMFs and INDs filing. From year 2010 European union also make compulsory for electronic CTD submissions to all procedures. Advantages of e-CTD  Relieves resource burdens related to paper distribution & storage  Access to applications Rapid reviewer access Facile management access  Facilitates finding information  Facilitates life cycle management  Provides a Standard Reviewing Environment FDA officially stated that the implementation date for the Stability Guidance is June 20, 2014 and not the previously indicated Current FDA Perspective on Leachable impurities in Parentral And Opthalmic Drug Products Current FDA Perspective on Leachable impurities in Parentral And Opthalmic Drug Products Test at least one batch on stability (6M accelerated and long-term through expiry) for leachables. Need proper detection and screening techniques (such as GC or HPLC) with acceptable LOD and LOQ. Leachable analytes may be compared to established in-house standards generated From Extractables study, Knowledge of CCS component composition. Leachable impurities typically reported in units of ppm. www.fda.gov www.ich.org www.esubmission.ema.europa.eu/ectd Molzon J; “The Common Technical Document: the changing face of New Drug Application”; Nature Reviews – Drug Discovery; Volume 2, January 2003; Page 71-74. http://en.wikipedia.org/wiki/Electronic_Commo n_Technical_Document Dossier is a file document submitted based on the requirement of the drug approval process. It is a comprehensive scientific document used to obtain worldwide licensing approval of a drug by diverse health authorities. Its creations, processing, compilation & dispatch to the field by a regulatory affairs department, is dependent upon many interrelated activities and the filling process in the emerging markets depends upon the region. The agreement to assemble all the Quality, Safety and Efficacy information in a common format (called CTD -Common Technical Document ) has revolutionised the regulatory review processes, and has led to harmonised electronic submission that, in turn, enabled implementation of good review practices. Drug regulatory affairs in pharma industries have mandated two types of dossier namely CTD (Common Technical Dossier) and ACTD (Asean Common Technical Dossier). Regulated pharma markets (eg.USA, Europe) markets require submission of dossier in CTD format which has to provide clinical trial and bioequivalence studies. As against this, semi-regulated pharma markets (South East Asian) require ACTD format which does not require exhaustive details like CTD. For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities. P08 Current trends in the CTD Dossier as per various Regulatory Agencies Current trends in the CTD Dossier as per various Regulatory Agencies Maximum permissible quantity of Methyl Paraben and Propyl Paraben as per EMA. Filing of more than 2 batches and 6 month stability data as per US FDA. Current FDA Perspective on Leachable Impurities in Parentral and Ophthalmic Drug products. EU Laws on falsified medicines. Use of Methyl and Propyl Paraben as Excipients in Medicinal Products for Oral Use as per EMA Use of Methyl and Propyl Paraben as Excipients in Medicinal Products for Oral Use as per EMA The European Commission has revised Guideline on excipient in label and package leaflet of medicinal products for human use (CPMP/463/00 rev.1) and a concept paper has been published in 2012 (EMA/CHMP/SWP/888239/2011). Parabens is one of the priorities among excipients under revision. Methyl Paraben and Propyl Paraben should be used inline with reflection paper EMA/CHMP/SWP/272921/2012. -Me Paraben 0.2% (All age groups) -Propyl Paraben 5 mg/kg/day ( Age 2+) CountryNo. BatchesSizeConditionDuration EU2/3Min 1 lac25/60 40/75 6M US1/3Min 1 lac25/60 40/75 6M Canada2Min 1 lac25/60 40/75 6M Australia2/3Min 1 lac25/60 40/75 6M Brazil3Min 50 thousand 30/75 40/75 12M Ecuador, Venezuela, Peru 3-30/75 40/75 12M Other Latam3-30/75 40/75 6M Filing of 3 Batches and 6 Month Stability Data as per US- FDA Filing of 3 Batches and 6 Month Stability Data as per US- FDA January 2, 2014. Under the current requirements ANDAs can be filed with one exhibit batch per strength and three months accelerated stability. After the implementation date ANDA will require three batches per strength (three pilot or two pilot and one lab scale) and six months of accelerated stability before filing an ANDA. EU laws on Falsified Medicines EU laws on Falsified Medicines In July 2011, the EU strengthened the protection of patients and consumers by adopting a new Directive 2011/62/EU on falsified medicines for human use. Falsified medicines are fake medicines that pass themselves off as real, authorised medicines. The European Union (EU) has a strong legal framework for the licensing, manufacturing and distribution of medicines, centred around the Directive on falsified medicines for human use, so that only licensed pharmacies and approved retailers are allowed to offer medicines for sale.