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

Just click on the various stages below to reveal the information.


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 In addition, the five-yearly cycle of Periodic Safety Update Reports (PSURs) with renewal has been replaced by a three-year cycle.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

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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