A report on the lecture by Roger Nosal, Pfizer, 2020 PDA/FDA Joint Regulatory Conference
Roger Nosal from Pfizer is the rapporteur of the ICH Internal Quality Discussion Group (IQDG) and presented goals, achievements and guidelines that are currently being updated. The IQDG focuses on technical and scientific aspects in its work. It aims to ensure that the ICH guidelines are up-to-date and reflect the current scientific knowledge.
The ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) has 17 members and 32 observers worldwide and is celebrating its 30th anniversary this year. Experts from industry and authorities work together to eliminate differences in the technical requirements for drug development in the three major pharmaceutical markets EU, Japan and USA. A large number of uniform, recommending guidelines (ICH guidelines) covering all aspects of the quality and safety of medicines, preclinical and clinical requirements have been drawn up and implemented in the participating countries.
ICH has greatly improved the global harmonisation of regulatory expectations. ICH has
The ICH Internal Quality Discussion Group (IQDG) has identified the following Quality Guidelines which either need to be established or revised:
Objectives of the new ICH Q13 Guideline are:
It is planned that the document will pass Step 1 (consensus in the drafting ICH Working Group) and Step 2 a/b (consensus in the ICH Assembly) in November 2020, followed by a public consultation. The final guidance could then be published in May 2022.
One topic that ICH has not yet addressed is the development of analytical methods. The new ICH Q14 guideline is intended to close this gap. At the same time, ICH Q2(R1) on the validation of analytical methods will be revised to complement modern analytical methods (e.g. NIR), to accomodate analytical performance criteria, multivariate models and Real Time Release Testing (RTRT).
The timeline is ambitious and final versions are scheduled for November 2021.
Rogar Nosal attached particular importance to the revision of ICH Q9. Risk management is now routinely applied in all areas of pharmaceutical production. Amendments to the guideline have become necessary as discrepancies have become apparent between how risk management is used in industry and how it is interpreted by the authorities.
Training materials will also be developed to introduce the changes and facilitate their implementation.
The final concept paper, which, according to Roger Nosal, looks very reasonable, is expected to be published in November 2020. The final version of the guideline is planned for 2022.
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