Pharmaceutical Registration Dossier & Format

 

Pharmaceutical Dossier is an Important & Critical part of Product Registration process, which is need to submit in Food & Drug Administration of the concerned Ministry of Health, of Regulatory Authority.


Different Regulatory Authority published their Standard format according to country Guidelines.


Common Pharmaceutical Dossier which is widely used in the Pharmaceutical Industry are:


CTD Dossier

ACTD Dossier

eCTD Dossier

Country Specific Registration Dossier


CTD Format Dossiers

This Format of Dossier is an Important & widely used Dossier format in most of the country, This format of any registration application for Marketing Authorization Dossier is submitted to Food and Drug Authority or Ministry of health or any other equivalent authority along with other required documents.

SGPRC provide registration file for drug product registration in various countries all over the world for many Pharmaceutical Company in INDIA & for our International Business Associates.

SGPRC Provides Registration Dossier service in  Dossier Compilation, Dossier Preparation & Dossier Review in accordance to the respective Regulatory Authority Guidelines.

Pharmaceutical Dossier Compilation, Review and writing as per CTD Format

(Common technical Document)


Common Technical Document Consists of the following Modules with the number of the

required Documents.

Module 1 – Administrative Information & Prescribing Information
Module 2 - Common Technical Documents Summaries
Module 3 –Quality
Module 4 – Non Clinical Study Report
Module 5 – Clinical Study Report

CTD Format Dossier is widely used in semi regulated & regulated market like CIS Countries, Middle East countries, European Union, USA , Australia, African Countries, Canada, Japan, etc

ACTD Format Dossiers


ACTD Format Dossier is also Described  as ASEAN CTD Dossier, ASEAN Common Technical Dossier (ACTD) provides a common format for the preparation of well-structured Common Technical Dossier applications for submission in ASEAN regulatory authorities for the registration of pharmaceuticals for human use. ACTD format significantly reduce the time and resources needed to compile applications for registration.  Regulatory reviews and communication with the applicant is facilitated by a standard document of common elements.


This guideline merely demonstrates an appropriate write-up format for acquired data. However,applicants can modify, if needed, to provide the best possible presentation of the technical information, in order to facilitate the understanding and evaluation of the results upon pharmaceutical registration.


Dossier writing and compilation as per ACTD Format.

Asian Common Technical Documents consists of following parts.

Part I – Administrative Data and Product Information
Part II – Quality Documents
Part III – Non Clinical Documents
Part IV – Clinical Documents.

ACTD Format is Asian harmonization for Common technical Documents used in

Asian Countries like Vietnam, Thailand, Singapore, and Malaysia, Philippines

& in Member States.

eCTD Format Dossier


This format of Registration Dossier is an electronic format for CTD Dossier, Submission in eCTD format should be in accordance with the current ICH M2 EWG eCTD specification,  Electronic files should be in accordance with the Guidance for Industry on Providing Regulatory Information in Electronic Format. The eCTD is an interface for the pharmaceutical industry to transfer regulatory information with various regulatory agencies. The content is based on the Common Technical Document (CTD) format. It was developed by the International Conference on Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG).















The US FDA and Europe EMEA announced that the eCTD is the preferred format for electronic submission (eSubmisson) of Drug Dossiers. The drug manufacturer has to submit the drug dossier in eCTD format.


NeeS format Dossier

Requirements for the submission of Non-eCTD electronic Submissions (NeeS). A separate EU guidance document covering eCTD submissions, which is regarded as the principal electronic submission format in EU.


A NeeS format submission can normally be started with any initial, variation or renewal MA submission.













Once the switch to this electronic format is made it is expected that further applications and responses relating to the particular medicinal product are submitted in NeeS format. Applicants can switch from NeeS to eCTD at the start of any new regulatory activity. Applicants should however not change from eCTD back to NeeS.

There is no requirement to reformat the whole dossier into NeeS format when switching from paper to NeeS, but this could be done at the applicant’s discretion.
.

Country Specific Format


This format of Registration Dossier is in accordance with the Specific Country Regulatory Guidelines.


SGPRC help you to compile and write entire dossier of specified modules as per Guidelines provided by the Government Regulatory Authorities, we also help Pharmaceutical companies to establish their Document Management and writing system by guiding them draft templates on BPR, BMR, COA , Standard Testing Procedure, Packing Procedures, and other technical documents. We can provide these documents as per company requirement. Good for startup companies or scale up companies.