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(CTD vs eCTD Explained – Difference, Structure & Regulatory Submission Guide) |
Regulatory Affairs field me kaam karne wale har professional ko CTD aur eCTD ka clear knowledge hona bahut jaruri hota hai. Jab bhi koi pharmaceutical company apni medicine ko US FDA, EMA ya kisi bhi global authority me submit karti hai, tab submission ka standard format CTD ya eCTD hota hai.
Aaj ke time me manual CTD ki jagah eCTD submission mandatory hota ja raha hai. Is article me hum simple language me samjhenge:
CTD kya hota hai
eCTD kya hota hai
Dono me kya difference hai
Modules ka structure
Career me iska use
CTD ka full form Common Technical Document hai jo ICH (International Council for Harmonisation) ne banaya tha. My main purpose was to create a common format for worldwide regulatory submissions.
eCTD ka matlab hai Electronic Common Technical Document. Yah CTD ka digital version hai jisme XML backbone aur lifecycle management hota hai. Aaj, US, Europe, Canada jaise market mein eCTD compulsory ho chuka hai.
Regulatory Affairs me jo bhi ANDA, NDA, MAH submission hota hai, wo CTD/eCTD format me hota hai. Regulatory executive ka main kaam documents ko correct module me arrange karna, formatting check karna aur agency ke portal par submit karna hota hai.
CTD ek standard structure hai jisme 5 modules hote hain:
Module 1 – Regional Information
Module 2 – Quality Overall Summary
Module 3 – Quality
Module 4 – Non-clinical
Module 5 – Clinical
CTD mainly paper-based ya simple PDF format me hota tha.
eCTD CTD ka electronic version hai jisme:
XML backbone
Hyperlinking
Lifecycle management
Sequence system
Validation rules
Use hote hain.
| Point | CTD | eCTD |
|---|---|---|
| Format | Paper/PDF | Electronic XML |
| Lifecycle | Manual | Automated |
| Submission | Physical | Online portal |
| Tracking | Difficult | Easy |
| Current Use | Limited | Mandatory |
B.Pharm / M.Pharm / Life Science
Regulatory Affairs knowledge
USFDA/EMA guidelines
Computer skills
ICH CTD structure
eCTD software
Document formatting
PDF bookmarking
Validation tools
Attention to detail
Fresher: ₹3 – 4.5 LPA
2–4 years: ₹5 – 8 LPA
Experienced: ₹9 – 14 LPA
CTD modules
eCTD lifecycle
sequence
validation
USFDA rules
ICH M4 guideline
USFDA eCTD guidance
Sample dossier
XML basics
Q1: CTD abhi bhi use hota hai?
Kuch countries me hota hai, lekin major markets me eCTD mandatory hai.
Q2: eCTD software kaun sa hota hai?
Lorenz, Extedo, GlobalSubmit, etc.
Q3: Fresher eCTD me ja sakta hai?
Haan, training ke baad easily.
CTD aur eCTD Regulatory Affairs ki backbone hain. Jo bhi student RA me career banana chahta hai, usko in dono ka practical knowledge hona compulsory hai. Future pura eCTD-based hai isliye digital submission skills sabse important ban chuki hain.
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