Module 18 - Drug Device Combinations and Other Technologies

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PRODUCT LIFECYCLE - REGULATORY CONTROLS

Discontinue product & terminate Marketing Authorisation

Tox Studies – Tests on animals

Clinical studies – Test on humans

Commercial Manufacture

Drug Development in Laboratory

Supply & Distribution

Drug Discovery

Market Research

Submit MAA

Submit CTA

GLP

GCP GMP (inc. GQCLP) GDP (not in USA) PV

PQS, required by all of the above

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EU Medicines Regulation

Regulations and Directives EudraLex

• Framework for control • Authorisations • Qualified Person

Translated into National Law

Volumes 1 to 10 • Directives

• Notes and guidance for Mkt. Authorisations • GMP for Medicinal Products (Directive & Guide) • Human and Veterinary Medicines

Marketing Authorisation (4 routes)

Manufacturing Authorisation

• SAFETY • QUALITY • EFFICACY

REG2000 © 2020 NSF Intl. These materials may not be used, copied, distributed or altered other than as permitted by NSF Intl. All rights reserved.

NSF Confidential

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