A review on drug approval process in US, Europe and India-dossier, bioavailability and bioequivalence studies

krishna Madagoni, Uppunuri Saidireddy, Himaja .


Pharmaceutical Regulatory Affairs (PRA) is a vital unit in a pharmaceutical company that successfully drives the Research and Development (R&D) efforts of the company to the market. In the present scenario, countries have different regulatory requirements for approval of a new drug. The single regulatory approach for marketing authorization application (MAA) of a new drug product applicable to various countries (on the basis of single dossier) is utmost difficult. Therefore, the knowledge of exact and detailed regulatory requirements for MAA of each country should be known to establish a suitable regulatory strategy. CTD was developed with the aim to provide a common format for the technical documentation that would significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and would ease the preparation of electronic submissions. Bioavailability and bioequivalence testing are essential in the drug development process as they create the foundation for regulatory decision making when evaluating formulation changes and lot-to-lot consistency in innovator products. They also serve as the primary components to demonstrate therapeutic equivalence between generic products and the reference innovator product. This article will focus the similarities and differences in drug approval process & requirements of the documents/CTD specifications to the drug regulatory authorities in the Europe, USA and India also focuses on submission and work flow related to bioavailability and bioequivalence studies.


regulatory approval process; CTD; EU; FDA; bioavailability; bioequivalence;

Full Text:



Debbie Jordan (2014). An overview of the common technical document (CTD) regulatory dossier. Medical Writing. 23(2):101-105.

Martin S. Lipsky, Lisa K. Sharp (2001). From idea to market: the drug approval process. J Am Board Fam Med. 14(5).

Mimansha Patel, Kunjal Patel (2013). An overview to CTD, ACTD and Indian requirements for dossier submission: Differences and similarities. Indo American Journal of Pharmaceutical Research. 3(2):1746-1751.

Monappa R. Sutra, Deepali R. Gawhane, C. R. Tenpe (2013). Study of drug regulatory approval process and comparative requirement of common technical document (CTD) in Europe, USA and India in coordination with drug developmental process. Int. J. Pharm. Sci. Rev. Res. 20(2):68-79.

Mulaje SS, Birajdar SM, Patil BR, Bhusnure OG (2013). Procedure for drug approval in different countries: A review. J. Drug. Deliv. Ther. 3(2):233-238.

Nitika Kaushal, Sachin Kumar Singh, Monica Gulati, Yogyata Vaidya et al, (2016). Study of regulatory requirements for the conduct of bioequivalence studies in US, Europe, Canada, India, ASEAN and SADC countries: Impact on generic drug substitution. Journal of Applied Pharmaceutical Sciences. 6(04):206-222.

Prajapati vishal, Goswami Rahulgiri, Makvana Pratik, Badjatya Jitendra Kumar (2014). A review on drug approval process for US, Europe and India. International Journal of dug regulatory affairs. 2(1):1-11.

Pratik Makvana, Dr. Dilip Maheshwari (2014). Regulatory requirements for marketing authorization of generic parentral product in European countries by decentralised procedure. Journal of Pharmaceutical Sciences and Bio scientific Research. 4(2):145-149.

Ramu B, Sathish Kumar M, Ramakrishna M (2015) Current Regulatory Scenario for Conducting Clinical Trials in India. Pharmaceut Reg Affairs. 4:137. doi: 10.4172/2167-7689.1000140

Santra Snigdha, Saxena Kinshuk, Anand Gaurav, Arora Tarun et al, (2011). Comparison of regulatory aspects for the conduct of bioavailability and bioequivalence studies. International Journal of Research in Pharmacy and Sciences. 1(2):1-17.

Swapna G, Bindhu Madhavi. Ch, Anusha P, Rupa T et al, (2014). Comparitive study of dossier submission process for drug product in USA, EU &Indian Regulatory. World Journal of Pharmaceutical Research. 3(6):406-411.

U. Nitin Kashyap, Vishal Gupta, H. V. Raghunandan (2013). Comparison of drug approval process in United States and Europe. J. Pharm. Sci & Res. 5(6):131-136.

DOI: http://dx.doi.org/10.21477/ijapsr.v1i4.6892


  • There are currently no refbacks.

Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.

Creative Commons License
International Journal of Applied Pharmaceutical Sciences and Research by Sierra Journals is licensed under a creativecommons.org/licenses/by/4.0/. https://creativecommons.org/licenses/by/4.0/
Based on a work at http://www.sierrajournals.com/direct/index.php/IJAPSR/issue/archive