Product Life Cycle Management in Europe: A Review

  • Krishnasis Chakraborty Al-Ameen College of Pharmacy, bangalore
  • Ravichandra V D

Abstract

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)

Keywords: Regulatory affairs, European standards, EMEA Guidelines, eCTD, Marketing Authorization, Product life-cycle management (PLM)

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References

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How to Cite
Chakraborty, K., and R. V D. “Product Life Cycle Management in Europe: A Review”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 3, Sept. 2022, pp. 32-41, doi:10.22270/ijdra.v10i3.551.