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Regulatory Roadmap for the development of human medicinal Products (Europe focus)

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	Licence Renewal
DESCRIPTION	Under the medicines legislation which was implemented on 30 October 2005, marketing authorisations (MAs) will be valid for five years and then may be renewed on the basis of a re-evaluation of the risk-benefit balance. Once renewed, the marketing authorisation will be valid for an unlimited period unless there are justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal. In addition, the five-yearly cycle of Periodic Safety Update Reports (PSURs) with renewal has been replaced by a three-year cycle.
INPUTS	Periodic Safety Update Reports (PSURs) PSUR Assessment reports Post-marketing studies PRMP
PROCESSES	GMP : Product Manufacturing GMP : Distribution GCP, GMP & GPVP : Post Marketing Studies GCP & GPVP : Pharmacovigilance
REGULATIONS	Control of Substances Hazardous to Health (COSHH) Commission Directive 2009/53/EC regarding variations to the terms of marketing authorisation for medicinal products Pharmacovigilance Regulation 726/2004/EC Commission Directive 2001/83/EC
GUIDANCE	Renewal of licences Volume 9A of the Rules Governing Medicinal Products in the EU MHRA The Good Pharmacovigilance Practice Guide (Purple Guide) publication MHRA Orange Guide TOPRA - The Organisation for Professionals in Regulatory Affairs Computer Systems Validation GAMP5 FDA Guidelines for Computer Systems Validation
OUTPUTS	Renewed Product Licence
RQA Courses/Seminars/eLearning	Professional Development Courses and Seminars eLearning
RQA Publications	Good Clinical Laboratory Practice (GCLP) Good Clinical Practice Regulatory Authority Inspections The Role of the Monitor in Veterinary Clinical Studies Pharmacovigilance Auditing Pharmacovigilance Inspection Guidance

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