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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 Granted

DESCRIPTION

Manufacturing Authorisation(s) and product licence granted for the medicinal product.
Commencement of post marketing surveillance requirements for the product and commencement/continuation of clinical trials required for line extension or new indications.

INPUTS

Common Technical Document (CTD) Dossier
Licensed/Compliant Manufacturing Facility

PROCESSES

GMP : IMP Manufacturing
GMP & GCO : Trial Supplies
GCP : Clinical Research (Phases I-IIIa)
GCP & GPVP : Pharmacovigilance

REGULATIONS

Pharmacovigilance

The reporting obligations under the provisions on pharmacovigilance for authorised medicinal products are set out in Directive 2001/83/EC and Regulation EC No. 726/2004

Clinical Research

Investigational medicinal product (IMP) Manufacturing

  • Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
GUIDANCE

        Volume 9A of the Rules Governing Medicinal Products in the EU
        MHRA: The Good Pharmacovigilance Practice Guide

Product Manufacturing

GMP
MHRA Orange Guide

Computer Systems Validation

OUTPUTS Product Licence
Label and regulatory approval finalised
Sustain and maximise sales by introducing Life Cycle Management (LCM) line extensions
PRMP implemented, strategy for post launch surveillance defined 
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