Product Life Cycle Management in Europe: A Review
This review article helps to study the practical aspects of different phases of life cycle of pharmaceutical products including sterile and non-sterile dosage forms in regulated market of Europe, to study the European standards and their requirements for new registration of injectable drugs, to study the product life cycle start from the product identification by market surveying and till its withdrawal or renewal in the Europe market, the data may contain official information to be taken from the EMEA guidelines, prepare, compile and submit the regulatory data according to the eCTD format to the regulatory agencies of Europe as critical phase of life cycle. The pharmaceutical industry is today conceivably the most highly regulated of all industries demanding a high level of information to be submitted to governments before a pharmaceutical product is brought to the marketplace. Each country holds different regulatory department. In this scenario, the product life cycle management in regulated market of Europe sustains a significant value. (1-2)
2. Chakraborty K, Yadav K. Drug approval process in US, Europe and India and its regulatory requirements: A Review. Int J Drug Reg Affairs [Internet]. 2018Sep.15 [cited 2022 Jul 17];6(3):31-9. Available from:
3. European Commission: The Notice to Applicants; Volume 2A; Procedures for marketing authorization [Internet]. EC; 2018 Mar 15 [cited 2022 Jul 17]. Available from:
http://ec.europa.eu/health/files/eudralex/vol-2/a/vol2a_ chap1_2005- 11
4. Ghalamkarpour A. Marketing Authorization Procedures in the European Union - Making the Right Choice [Internet]. 2009 Dec [cited 2018 Jun 10]. Available from:
5. European Commission, Pharmaceuticals in the European Union [Internet]. 2019 Jan 7 [cited 2022 Jul 17] Available from:
6. Target dates for the submission of responses are published on the EMA website [Internet]. 2019 Jan 05 [cited 2022 Jul 17]. Available from:
7. European Commission. Volume 2A, Procedures for marketing authorisation. Chapter 4 Centralised Procedure [Internet]. 2006 Apr 01[cited 2022 Jul 17]. Available from:
8. Source: European Commission, Pharmaceuticals in the European Union [Internet]. 2019 Jan 07 [cited 2022 Jul 17] Available from:
9. EMA. Guideline on non-clinical local tolerance testing of medicinal products, EMEA; 2015 [Internet]. EMA; 2018 Jan 10 [cited 2022 Jul 17]. Available from:
10. CDER Guidance: A review for OCRA US RAC Study [Internet]. CDER; 2018 May 25 [cited 2022 Jul 17]. Available from:
11. PG Smith, GM Merritt Proactive Risk Management: Controlling Uncertainty in Product Development. Strategy 2 market; 2002.
12. M George, L Joseph, S Sandal and SM Joseph Product Life Cycle Management in Regulated Market of Europe. Pharma Regulatory Affairs. 2017;6:181.
13. Smith CG, O'Donnell JT The Process of New Drug Discovery and Development. 2nd Edition. Information Publishing Company; 2006.
14. Rick NG., Drugs from discovery to approval. New Jersey: John Wiley & Sons; 2015.
15. IRA R Berry, Robert P Martin, editors. The Pharmaceutical Regulatory Process. 2nd ed. Informa healthcare: 45; 2019.
16. Kashyap UN, Gupta V. Raghunandan H V. J. Pharm. Sci. & Res. 2013;5(6):131-6.
17. Jawahar N, Shrivastava N, Ramachandran, Priyadharshini B R. J. Pharm. Sci. & Res. 2015;7(4):219-25.
18. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use, Stability Testing of New Drug Substances and Products Q1A (R2) [Internet]. 2003 Feb 06 [cited 2022 Jul 31] Available from:
19. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use, Validation of Analytical Procedures: Text and Methodology Q2 (R1) [Internet]. 2005 Nov 01 [cited 2022 Jul 31] 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