Module 9 2024

03/09/2024

What is it like here?

We are heavily regulated

•

• This is a good thing, but expensive

• Extensive technical guidance is available

Guidance is harmonised

•

Advice is easily accessible

•

• We understand established development and regulatory pathways

• Industry and regulators can collaborate

• Regulators are proactive in the face of advancing technology

• Unmet clinical needs can be addressed

The Organisation for Professionals in Regulatory Affairs

47

• ICH (ICH Official web site : ICH) • ICH Q2(R1) Validation of Analytical Procedures • ICH Q5A(R1) Viral Safety Evaluation of Biotechnology Products • ICH Q5C Stability Testing of Biotechnology Products (additional to Q1A) • ICH Q5D Derivation and Characterisation of Cell Substrates (i.e. host cells, cell banks) • ICH Q5E Comparability of Biotechnology/Biological Products • ICH Q6A Specifications : Test Procedures and Acceptance Criteria • ICH Q8, Q9, Q10 Quality risk management • Regional (EMA) • Community Directives • 2001/83/EC Medicinal Products for Human Use • 2003/94/EC Guidelines of Good Manufacturing Practice in respect of medicinal products for human use and investigational medicinal products for human use. • Guidelines • Guideline on development, production, characterisation and specification for monoclonal antibodies and related products (europa.eu) • Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission • Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev.3 • Guideline on Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials (Jan 2022) Types of Guidance’s Relevant to Biologicals

The Organisation for Professionals in Regulatory Affairs

48

24