Good Practices in Management of deficiencies in CTD dossier and comparative study for US, EU and Australia
This topic aims at reviewing the drug and drug product filing and obtaining USFDA EMEA and TGA approval and its effective role to improve the standards which are laid by them. The respective Regulatory Agency approves the new/generic drug products that govern respective market before introduction of particular product into the market. The Regulatory Agency approves the entire new drug product to be safe and effective before marketing. USFDA is the Regulatory Agency which is responsible for the regulation of food and drug product in USA. EMEA is the Regulatory Agency which is responsible for the regulation of food and drug product in Europe. TGA is the Regulatory Agency which is responsible for the regulation of therapeutic goods in Australia.
A dossier contains detail information about the drug substance and drug product and result of studies that are carried out in development process. For getting market authorization has to be submitted to the respective regulation bodies. Due to various regulations, ICH introduced CTD for such countries that come under it. CTD is critical for dossier submission. For regulatory submission that is to be accepted in all ICH countries.
CTD provides standardized structure. CTD makes filing easier globally. But there are differences in dossier submission requirements in these countries i.e. Module I is country specific and other regional guideline are also considered while compiling dossier application.
2. M4: The Common Technical Document [Internet]. ICH; 2019 [cited 2019 Sept 06]. Available from:
3. Patel DH, Badjatya JK, Patel AA. Preparation and Review of Chemistry, Manufacturing and Control (CMC) sections of CTD Dossier for Marketing Authorization. International Journal of Drug Regulatory Affairs. 2017; 5(2):1-12.
4. Gupta RM. Top 50 Deficiencies in CTD Dossiers [Internet]. [Cited 2019 April 09].Available from: http://www.perfectdossier.com/pdf/Top%2050%20Deficiencies%20in%20CTD%20Dossiers.pdf
5. Pisano DJ, David M. Overview of Drug Development and the FDA. In: Pisano DJ, FDA Regulatory Affairs: A guide for Prescription Drugs, Medical Devices, and Biologics. Florida: CRC Press LLC; 2004.p.2-20
6. United State Food and Drug Administration. New Drug Application. [Internet]. FDA; 2019 Oct 06 [Cited 2019 Oct 18].Available from:
7. Kashyap UN, Gupta V, Raghunandan HV. Comparison of drug Approval Process in United States and Europe. Journal of Pharmaceutical science and Research. [Internet]. 2013 [cited 2019 Sept 07]; 5(6):131-6. Available from:
8. Rick NG. Drugs from discovery to approval. 2nd ed. Hoboken, New Jersey:John Wiley & Sons, Inc; 2009. p. 212-14
9. Vishal P, Goswami R, Makvana P. A Review on Drug Approval Process for US, Europe and India. International Journal of Drug Regulatory Affairs. 2014; 2(1):1- 11.
10. Berry Ira R, Martin RP, editors. The Pharmaceutical Regulatory Process. 2nd ed. USA:CRC Press; 2008 Dec.p. 50
11. Berry Ira R, Martin RP, editors. The Pharmaceutical Regulatory Process. 2nd ed. USA:CRC Press; 2008 Dec.p. 51
12. Rick NG. Drugs from discovery to approval. 2nd ed. Hoboken, New Jersey:John Wiley & Sons, Inc; 2009. p. 218-20
13. Berry Ira R, Martin RP, editors. The Pharmaceutical Regulatory Process. 2nd ed. USA:CRC Press; 2008 Dec.p. 49
14. Mahapatra AK, Samreeja NH and Murthy PN. Drug Approval Process- In United States of America, European union and India: A Review. Applied Clinical Research, Clinical Trials & Regulatory Affairs; 2014.p.13-22
15. Rick NG. Drugs from discovery to approval. 2nd ed. Hoboken, New Jersey:John Wiley & Sons, Inc; 2009. p. 215-17
16. Therapeutic Goods Administration. Prescription Medicines Registration Process, Version 2.3. [Internet]. TGA; 2018 Mar [cited 2019 Sept 12]. Available from:
17. Lifecycle Management: EU and US variation Requirements. Issue 1(1): pp:i-iv [Internet]. TOPRA; 2017 [cited 2019 Sept 23]. Available from: https://www.topra.org/topra/topra_member/pdfs/Lifecycle%20CPD%20-%20Jan%202017.pdf
18. Tamboli AM, Todkar P, Zope P and Sayyad FJ. An Overview on Bioequivalence: Regulatory Consideration for Generic Drug Products. Journal of Bioequivalence & Bioavailability [Internet]. 2010 [cited 2019 Sept 05]; 2(4):086-092. Available from: https://www.longdom.org/open-access/an-overview-on-bioequivalence-regulatory-consideration-for-generic-drug-products-jbb.1000037.pdf
19. Bioavailability and Bioequivalence studies submitted in NDAs and INDs [Internet]. US: CDER, FDA; 2014 Mar [cited 2019 Oct 23]. Available from:
20. Guideline on investigation of Bioequivalence, European Medicine Agency, Doc. Ref.: CPMP/EWP/QWP/1401/98 Rev. 1/ Corr [Internet]. London: EMEA; 2010 Jan 20 [cited 2019 Sept 18]. Available from:
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM