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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	Control of Substances Hazardous to Health (COSHH) Animals (Scientific Procedures) Act 1986 Statutory Instrument 1031 - SI 2004/1031 Statutory Instrument 3144 - SI 1994/3144 ICH M4 - Common Technical Document for the Registration of Pharmaceuticals for Human use EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use 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 Directive 2001/83/EC Regulation (EC) No 726/2004 Regulation (EC) No 540/95 regarding reporting suspected unexpected adverse reactions which are not serious Clinical Research Clinical Trials Directive 2001/20/EC Commission Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products 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 GAMP5 FDA Guidelines for 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

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