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M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific Acceptable Intakes - PharmaFacts
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M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific Acceptable Intakes

 

M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific Acceptable Intakes

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This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.

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For questions regarding this draft document, contact (CDER) Aisar Atrakchi 301-796-1036 or (CBER) Anne Pilaro 240-402-8341.

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

ICH HARMONISED GUIDELINE

ADDENDUM TO ICH M7: ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK

APPLICATION OF THE PRINCIPLES OF THE ICH M7 GUIDELINE TO CALCULATION OF COMPOUND-SPECIFIC ACCEPTABLE INTAKES

M7(R1)

Current Step 2 version dated 9 June 2015

At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Steering Committee to the regulatory authorities of the ICH regions (European Union, Japan, USA, Canada and Switzerland) for internal and external consultation, according to national or regional procedures.


Click HERE for full Guidance