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Final ICH M7 Guideline on Genotoxic Impurities published



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GMP News: Final ICH M7 Guideline on Genotoxic Impurities published,8500,S-QSB_n.html


On on 15 July 2014, the ICH issued the guideline M7 “Assessment and Control of DNA reactive (mutagenic) Impurities in Pharmaceuticals to limit Potential Carcinogenic Risk” as Step 4 document. in In the last step of the ICH process (Step 5) this guideline now has to be implemented in the national regulations in the three ICH regions Europe, United States and Japan. The final M7 Guideline was published exactly 17 months after the release of the draft consensus guideline (Step 2) in February 2013, where it could be commented in a 6-month period.

The guideline comprises information, how impurities in pharmaceutical products relative to their genotoxic potential have to be evaluated with the analysis of structure-activity relationships and how the critical toxicological threshold (threshold of toxicological concern TTC) has to be determined. In the individual chapters, some highly complex issues and scenarios are covered – as, for instance, the question why potentially genotoxic substances with similar molecular structure and probably the same mechanism of action should still not be combined for the calculation of the TTC. Another problem the Guideline tries to clarify is the different values of the TTC, depending on the duration of the use of the medicinal product.

The last section of the document contains a statement of the ICH, that due to its complexity the guideline has to be implemented in the respective national rules and regulations after 18 months only. However, the following exceptions apply to some requests:

  • For the implementation of Ames tests the specifications of M7 have to be applied immediately. However, the Ames tests carried out before release of M7 need not be repeated.
  • The development programmes having started phase 2b/3 prior to publication of M7 can be continued. The requirements for the execution of two quantitative analyses of structure-activity relations (section 6), for impurity assessment (section 5) and for the documentation (section 9) do not have to be considered, though.
  • For a new marketing authorisation application which does not include the phase 2b/3 clinical trials, compliance with the aforementioned points is expected until 36 months after the publication of M7.

Compared to the previous Guideline version (Step 2) it now contains changes, clarifications and precisions in several parts. For a more detailed analysis of the new M7 Guideline please see one of our next newsletters.

The ECA will conduct the Impurities Forum 2014in Berlin, where a complete day will be dedicated to the implementation of Genotoxic Impurities ICH M7. On another day you will cover the implementation of Elemental Impurities ICH Q3D – whose finalisation is scheduled for September. The days can be booked separately or alternatively the entire 3 days of the Impurities Forum.

1 Comment

  1. Ben Warlick says:

    Fantastic piece . I was enlightened by the information – Does anyone know if my business can acquire a sample a form version to fill in ?

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DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries...... , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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