Overview of Drug Approval Process and Post Approval Changes in Europe

  • Sakshi A Navale Department of Regulatory Affairs, SNJBs Shriman Sureshdada Jain College of Pharmacy, Neminagar, Chandwad, 423101, Dist. Nashik, Maharashtra, India.
  • Ganesh D. Basarkar


The European Medicines Agency (EMA) is facilitate development and access to medicine, evaluating applications for marketing authorization, monitoring the safety of medicines across their lifecycle and providing information to healthcare professionals and patients.

In order to obtain a marketing authorization in Europe, a medicine must meet a number of criteria before it can be filed with the European Medicines Agency (EMA). This article is looks at the EMA’s Drug approval process and post approval changes. The decentralized regulatory body, or EMA, is in charge of overseeing the safety of food and drug (pharmaceutical products) in Europe. The applications are examined, and member state looks over the safety and effectiveness data before approving the drug.  EU establishes 4 different drug approval processes:

1)      National Procedure

2)      Decentralized Procedure

3)      Centralized Procedure

4)      Mutual Recognition Procedure

The goal of the current study is to clarify the function of post-approval change management in preventing non-compliance. The current study has concentrated on locating the current regulations and practices in this field and comprehending the fundamental ideas for post approval compliance for licenses relevant to marketing permission. Though change management is essential to a pharmaceutical's lifespan that is the study's main finding. However, the expense of compliance has escalated due to a lack of a clearly defined framework and a lack of understanding of the same, which has led to step-motherly treatment being applied to compliance and license maintenance.


Europe has the highest thought-due approval rates worldwide. The European Medicines Agency (EMA) aims to guarantee that patients in the EU have access to medicines that are of the highest caliber, are reliable, and are secure. Public regulatory agencies have the responsibility of ensuring that pharmaceutical firms follow the law. In order to ensure patient safety and well-being, laws mandate that pharmaceuticals be created, tested, tracked, and manufactured in compliance with the standards. A guideline, in addition to the European legislation that defines variation types, gives out a harmonized list of anticipated variations with categorization codes. A defined list of variations for European

A MA has existed since 1998. Legislation has been amended on a regular basis, and the most recent amendment, in August 2013, made implementation mandatory at the national level, and the variation process was totally harmonized across the EU.

Keywords: EMA, Drug approval, post approval changes, Market Authorization, Decentralized Procedure, National Procedure, Centralized Procedure, Mutual Recognition Procedure


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How to Cite
Navale, S. A., and G. D. Basarkar. “Overview of Drug Approval Process and Post Approval Changes in Europe”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 4, Dec. 2023, pp. 1-15, doi:10.22270/ijdra.v11i4.627.