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ICH announces Q&A Document on Q11 Guideline – Main Focus: API Starting Materials
The ICH has recently published a Business Plan and a Concept Paper on the elaboration of a Q&A document on the ICH Q11 Guideline. Read more here.
ICH announces Q&A Document on Q11 Guideline – Main Focus: API Starting Materials
The ICH Q11 Guideline entitled “Development and Manufacture of Drug Substances” from May 2012 has been implemented in the three ICH regions EU, USA and Japan for 2 years now. It describes the approach to developing APIs based on an in-depth understanding of the manufacturing process and adequate strategies to control this process. The document indicates what information should be provided about the quality of the API in Module 3 of the CTD (Common Technical Document) within the framework of a marketing authorisation application.
In the meantime, there has been an accumulation of cases where the applicant and the regulatory authorities adopted different positions with regard to the interpretation of the requirements in this guideline. Particularly, this concerned the definition of starting materials for the manufacture of APIs. The standards according to which regulatory authorities accept a specific compound as a starting material are far from uniform across the 3 ICH regions, and, all the more across Europe. It is thus obvious that this – in the context of global authorisation procedures – costs a lot of time, energy and money.
The ICH has now faced this problem and created an Implementation Working Group (IWG) which has the task of elaborating a Q&A document on API Starting Materials. As is usual in such circumstances (see also our News from 10 December 2014), the ICH has justified the necessity of the Q&A document in a Business Plan and a Concept Paper – both entitled “Q11: Q&As on Selection and Justification of Starting Materials for the Manufacture of Drug Substances”. (Business Plan and Concept Paper are the 1st step of the ICH procedure consisting of 5 steps. The last step always ends with a “Harmonised Tripartite Guideline”.)
The Concept Paper provides further details about the benefits expected of the Q&A document for the industry, authorities and patients:
- The selection and justification of starting materials should be extensively harmonised.
- The connection between the selection of starting materials and GMP aspects, control strategies, length of the chemical syntheses (number of synthesis steps) and the relevance of the manufacturing steps with regard to the API quality should be clarified.
- It should be specified which information has to be provided in the application dossier for the justification of the selection of the starting materials.
- The expectations regarding the lifecycle management should be explained.
This Question-&-Answer document is certainly interesting for all those confronted with diverse regulatory expectations regarding starting materials in relation to supra-regional registration and marketing authorisation procedures. Yet, according to the timing indicated in both the Business Plan and the Concept Paper, a first draft of this document (as Step 2a/b) should be released in one year at the earliest, namely in November 2015.
Final ICH M7 Guideline on Genotoxic Impurities published
GMP News: Final ICH M7 Guideline on Genotoxic Impurities published
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.
ICH gets new Members and informs about the ICH Q3D Implementation
ICH gets new Members and informs about the ICH Q3D Implementation
The International Conference on Harmonisation (ICH) is the most significant organisation for the harmonisation of requirements with regard to the authorisation and the manufacture of medicinal products. Read more about the current decisions of the ICH Steering Committees.
ICH gets new Members and informs about the ICH Q3D Implementation\
The International Conference on Harmonisation (ICH) is the most significant organisation for the harmonisation of requirements with regard to the authorisation and the manufacture of medicinal products. The ICH wants this function to be extended. For that reason – during the last meeting in Minneapolis, USA – the Steering Committee decided to welcome two new members. Beside the American FDA, the EMA/EU Commission and the Japanese Authority belong to the founding members. Now, the Swiss Authority Swissmedic and the Canadian one (Health Canada) have joined the ICH Board.
Another important notice has been announced after the meeting in Minneapolis. In September 2014, the harmonised Guideline ICH Q3D Elemental Impurities will reach the Step 4 status. The FDA as well as the EMA/EU Commission and the Japanese MHLW will take over the whole document into their respective national regulations. This last – and formal – procedure will be defined as Step 5. No changes will be made in the guidance document when the authorities will make the transfer to the regulatory framework.
The new ICH Q3D and the recently adopted ICH M7 (Genotoxic Impurities) will therefore be addressed at the international Impurities Forum in Berlin.
Source: Press Release of the ICH Meeting in Minneapolis
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