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Never miss these while 

writing the  
"​Common Technical 
Document (CTD)  
for Pharmaceutical​" 
 

© 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent
PEPGRA Healthcare Pvt Ltd
INDIA: Nungambakkam, Chennai, 600 034.
UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX.
Email:info@pepgra.com, Web:www.Pepgra.com.
Scientific Regulatory writing​ is a complex process due to its dossier size, data complexity, 
and submission deadlines and it requires specialized domain specific knowledge, 
understanding of drug development process, pharmacology, statistical and writing skills 
to develop superior regulatory documents as per the exact requirements of the 
regulatory authority. Besides, the scientific writer must be familiar with technical 
guidelines prevailing in countries like European Union (EU), USA, Japan that includes ICH 
E3 to write clinical study reports, periodic safety reports (ICH E2C), publication guidelines 
(e.g. CONSORT, STROBE, PRISMA), the International Committee of Medical Journal Editors 
(ICMJE) guidelines for manuscripts.  

Common Technical Documentation(CTD) 

The ​Common Technical Document ​(CTD) is an international standard for the summary 
documents relating to quality, safety and efficacy information of medicinal products. The 
CTD is mandatory for the registration of medicines. International Council for 
Harmonization (ICH) mandates to obtain regulatory approval of new drug applications of 
Pharmaceutical companies operating in European Union states. The main aim of CTD is 

© 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent
PEPGRA Healthcare Pvt Ltd
INDIA: Nungambakkam, Chennai, 600 034.
UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX.
Email:info@pepgra.com, Web:www.Pepgra.com.
to achieve greater harmonization in new drugs development and registration. The 
standard encompasses the entire spectrum of documentation to be integrated into a 
regulatory submission dossier, thereby offering complete guidance to pharmaceutical 
companies as to how formulation and manufacturing information supporting the quality 
parameter as well as the results of non-clinical and clinical research needs to be 
organized and presented.  

While developing CTD dossier, the regulatory writer needs to possess a complete 
understanding of the various requirements and supporting documents in order to avoid 
getting rejected by the regulatory authority for missing important sections and 
resubmission.  

Scientific ​Regulatory writing services​ offer great assistance to pharmaceutical 


companies in preparing high-quality CTD and its timely submission, resulting in early 
approval of new drugs from the regulatory authorities.  

CTD dossier​ consists of five main modules 

● Module 1​ : Administrative information and prescribing information; 


● Module 2​ : Overviews and summaries of Modules 3–5;  
● Module 3​ : Quality (pharmaceutical documentation);  
● Module 4​ : Non-clinical reports relating to pharmacology, toxicology  
● Module 5​ : Clinical study reports (clinical trials). 

© 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent
PEPGRA Healthcare Pvt Ltd
INDIA: Nungambakkam, Chennai, 600 034.
UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX.
Email:info@pepgra.com, Web:www.Pepgra.com.
Important areas not to be missed in ​CTD document 

Module 1 of CTD dossier needs to contain region-specific documents. Module 2 provides 


overview and summaries of modules 3, 4 and 5. This section needs to provide a general 
introduction about the new drug applied along with its mechanism of action and 
proposed clinical use.   

Clinical summaries section needs to sum up information from individual studies including 
summaries and detailed study reports that focus on data summarization and integration.  

It is advisable for the pharmaceutical companies to take the assistance of ​Scientific 


regulatory writers​ for writing clinical overview and a clinical summary section of module 2 
of CTD dossier, as it requires both short summaries and detailed study reports. 

About ​Pepgra 

Pepgra is a quality-driven Contract Research Organisation (CRO) comprising advanced 


regulatory writers capable of delivering clinical study protocols and study reports in 
complete compliance with the ICH GCP guidelines. Pepgra offers complete assistance to 
the pharmaceutical and medical device companies to develop scientifically accurate CTD 
document and has extensive experience in  

➢ Full Dossier development 


o Clinical overview (eCTD Modules 2.5) including Literature Review 
o Module 2.3: Quality Overall Summary (QOS) 
o Module 2.4/2.6: Non-Clinical Overview/ Summary 
o Module 2.5/2.7: Clinical Overview / Summary 

Thus, Pepgra can be immense help in ​developing clinical trials​ for their new drug 
development process and Pepgra’s ​clinical trial scientific regulatory writers​ ​provide 
well-written documents resulting huge savings in time and money.  

About Author 
Dr.Nancy, 

Editor-in-chief, 

PEPGRA Healthcare Pvt Ltd​. 

© 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent
PEPGRA Healthcare Pvt Ltd
INDIA: Nungambakkam, Chennai, 600 034.
UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX.
Email:info@pepgra.com, Web:www.Pepgra.com.