Q6B – Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

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Q6B – Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

The ICH Harmonised Guideline was finalised under Step 4 in March 1999.

This document provides general principles on the setting and justification of a uniform set of international specifications for proteins and polypeptides which are produced from recombinant or non-recombinant cell-culture expression systems.

The scope of this part is initially limited to well-characterised biotechnological products, although the concepts may be applicable to other biologicals as appropriate.

In view of the nature of the products, the topic of specifications include in-process controls, bulk drug, final product and stability specifications and give guidance for a Harmonised approach to determining appropriate specifications based on safety, process consistency, purity, analytical methodology, product administration and clinical data considerations.

The ICH Harmonised Guideline was finalised under Step 4 in July 1997. This document covers the preclinical safety testing requirements for biotechnological products. It addresses the use of animal models of disease, determination of when genotoxicity assays and carcinogenicity studies should be performed, and the impact of antibody formation on duration of toxicology studies.

An addendum was proposed to provide clarification on S6 and an update of the following topics discussed in the original ICH S6 Guideline: species selection, study design, immunogenicity, reproductive and developmental toxicity and assessment of carcinogenic potential. The Harmonised addendum provides further complementary guidance to the S6 Guideline and helps to define the current recommendations and reduce the likelihood that substantial differences will exist among regions.

The addendum reached Step 4 of the harmonisation process in June 2011 and was integrated as part II in the core Guideline that was then renamed S6(R1).

Guideline

Q6B Guideline

Annexes

Guideline implementation

ANMAT, Argentina

Not yet implemented;

ANVISA, Brazil

Implemented; Date: 1 August 2011; Reference: RDC 413/2020

COFEPRIS, Mexico

In the process of implementation; Date: 25 February 2022; Reference: Pharmacopeia of the United Mexican States 13.0.

EC, Europe

Implemented; Date: 1 September 1999; Reference: CPMP/ICH/365/96

EDA, Egypt

Implemented; Date: 31 December 2008; Reference: Regulatory guide for mechanisms, procedures and rules of implementing the decree of Egyptian Drug Authority No.343 of 2021

FDA, United States

Implemented; Date: 1 August 1999; Reference: Vol. 64, p. 44928

HSA, Singapore

Implemented; Date: 1 January 2008; Reference: These guidelines are cross-referred in M4Q and applied in the routine evaluation. See regulatory guidance.

Health Canada, Canada

Implemented; Date: 20 December 2001; Reference: File #: 01-118655-734

JFDA, Jordan

Implemented; Date: 1 March 2008;

MFDS, Republic of Korea

Implemented; Date: 30 December 2014; Reference: Regulation on Approval and Review for Biologics, ETC. [MFDS, Republic of Korea Notification] Guidelines on the Evaluation of quality, safety and efficacy of recombinant protein products [Guideline-0324-01]

MHLW/PMDA, Japan

Implemented; Date: 1 May 2001; Reference: PMSB/ELD Notification No. 571

MHRA, UK

Implemented; Date: 6 December 1995;

NAFDAC, Nigeria

Not yet implemented;

NMPA, China

In the process of implementation;

SAHPRA, South Africa

In the process of implementation;

SFDA, Saudi Arabia

Implemented; Date: 22 September 2011;

Swissmedic, Switzerland

Implemented; Date: 10 March 1999; Reference: ICH Guidelines apply in Switzerland automatically upon reaching Step 4: Swissmedic Journal 05/2006, p. 504

TFDA, Chinese Taipei

Implemented; Date: 3 January 2002; Reference: 1.Regulation for Registration for Biotechnological Products for Human Use 2. Guidance for Specifications: Test Procedures and Acceptance Criteria for Biotechnological/ Biological Products

TITCK, Türkiye

Implemented; Date: 11 December 2021; Reference: Q6B is referred to in Guideline on Requirements for Quality of Biological İnvestigational Medicinal Products in Clinical Trials; and Guideline on Common Technical Document (CTD)