A Comprehensive and Comparative study of qualification process for Drug Development tools in US, Europe, Japan and India.
Drug Development Tools are methods, materials, or measures that have the potential to facilitate drug development. USFDA has specified three major drug development tools and has also given the guidelines recommending their qualification which would expedite the drug development process. This qualification would ensure better understanding of drug targets and long term safety outcomes. Regulatory authorities of Europe, Japan & India have also focused on developing a formal qualification process of drug development tools though most of it follows USFDA.
2. Strimbu K, Tavel JA. What are Biomarkers?, Current opinion in HIV and AIDS [Internet]. 2010 [Cited 2018 Jan 04]; 5(6). Available from:
3. Ed Miseta, What You Need To Know About FDA's Clinical Outcome Assessment Compendium [Internet]. Clinical leader; 2016 Feb 08 [Cited 2018 Jan 06].Available from:
4. Committee on Animal Models for Assessing Counter measures to Bioterrorism Agents [Internet]. The National Academy Press; 2011 [Cited 2018 Jan 08]. Available from:
5. U.S. Department of Health and Human Services, Food and Drug Administration. Guidelines on Qualification Process of Drug Development Tools [Internet]. Center for Drug Evaluation and Research (CDER); 2014 Jan [Cited 2018 Jan 08]. Available from:
6. EMA. Qualification of novel methodologies for drug development: guidance to applicants [Internet]. EMEA; 2009 [Cited 2018 Jan 08]. Available from:
7. EMA. Reflection paper on methodological issues associated with pharmacogenomic biomarkers in relation to clinical development and patient selection [Internet]. EMEA; 2015 [Cited 2018 Jan 09]. Available from:
8. EMA. Reflection paper on co-development of pharmacogenomic biomarkers and Assays in the context of drug development [Internet]. EMEA; 2010 [Cited 2018 Jan 09]. Available from:
9. EMA. Guideline on non-clinical local tolerance testing of medicinal products [Internet]. EMEA; 2015 [Cited 2018 Jan 10]. Available from:
10. Nieto-Gutierrez M. Non-clinical Assessment Requirements. Safety and Efficacy of Medicines/Human Medicines Development and Evaluation [Internet]. EMEA; 2011 [Cited 2018 Jan 10] Available from:
11. ICH E 16: Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions [Internet].EMEA; 2009 [Cited 2018 Jan 10]. Available from:
12. Technical Guidance on Development of In Vitro Companion Diagnostics and Corresponding therapeutic Products [Internet]. [Cited 2018 Jan 10]. Available from:
13. Notification on Approval Application for In Vitro Companion Diagnostics and Corresponding Therapeutic Products [Internet]. PMDA; 2013 July 01[Cited 2018 Jan 10]. Available from:
14. Kagiyama N, et.al. Japanese Guidelines & Regulations for Scientific & Ethical Animal Experimentation [Internet]. Japan: 2006 [Cited 2018 Jan 11]. Available from:
15. Omoe H. Recent Trends in Animal experimentation in Japan - On the Revision and Implementation of the Law for the Humane Treatment and Management of animals. [Internet]. Life Science Research Unit; 2006 Oct [Cited 2018 Jan 11]. Available from:
16. Discussion paper. Workshop on Policy Issues for the Development and Use of Biomarkers in Health [Internet]. OECD; 2008 [Cited 2018 Jan 11]. Available from:
17. ICMR. Inserm Development of Biomarkers for CVD & Diabetes [Internet]. ICMR; 2007 [Cited 2018 Jan 12]. Available from:
18. CPCSEA Guidelines For Laboratory Animal Facility, Committee for the Purpose of Control and Supervision on Experiments on Animals. Indian Journal of Pharmacology [Internet].2003 [Cited 2018 Jan 12]; 35:257-74. 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
Rights of Authors:
The International Journal of Drug Regulatory affairs. recognize the retention of the following:
- Patent and trademark rights and rights to any process or procedure described in the article.
- The right to photocopy or make single electronic copies of the article for their own personal use, including for their own classroom use, or for the personal use of colleagues, provided the copies are not offered for sale and are not distributed in a systematic way outside of their employing institution (e.g. via an e-mail list or public file server). Posting of an article on a secure network (not accessible to the public) within the author’s institution is permitted.
- The right, subsequent to publication, to use the article or any part thereof free of charge in a printed compilation of works of their own, such as collected writings or lecture notes.
Note: All copies, paper, electronic or other use, of the information must include an indication of the IJDRA copyright and a full citation of the journal source.
- If the article was prepared jointly with other author(s), the signing author has informed the co-author(s) of the terms of this copyright transfer and is signing on their behalf as their agent and represents that he or she is authorized to do so, then please confirm by checking the appropriate box following the signature line. The signing author shall bear the responsibility for designating the co-author(s) and must inform the IJDRA of any changes in authorship.
- If copyright is held by the employer, then the employer or an authorized representative of the employer must sign. If the author signs, it is understood that this is with the authorization of the employer and the employer’s acceptance of the terms of the transfer.
The author(s) warrant(s) that the article is the author’s original work and has not been published before. The author(s) warrant(s) that the article contains no libelous or other unlawful statements, and does not infringe on the rights of others. If excerpts from copyrighted works are included, the author(s) has (have) obtained or will obtain written permission from the copyright owners and will credit the source in the article.
Preprints: The author(s) must agree that if a prior version of this work (normally a preprint) has been posted to an electronic public server, they will not update and/or replace the prior version in order to make it identical in content to the final published version.