Latest Regulatory Updates

The International Council for Harmonisation (ICH) has published a draft Q&A presentation related to ICH Q11, providing further clarification and guidance on developing quality attributes of drug substances and products.

The International Council for Harmonisation (ICH) has made a presentation of the draft Addendum to the E11(R1) guideline on nonclinical safety testing of gene therapies available for review and comment on their website.

The International Council for Harmonisation (ICH) has made a presentation on the E6(R2) guideline, which addresses good clinical practice requirements for investigational drugs, available on its website to facilitate understanding and implementation.

The International Council for Harmonisation (ICH) has published reports from its Assembly and Management Committee meetings held in Osaka, November 2016, detailing discussions and decisions related to ongoing standards development efforts.

The International Council for Harmonisation (ICH) has published a Concept Paper on the Multi-Part Concept Paper (M1 PtC) to facilitate greater clarity and consistency in the submission of quality modules within regulatory submissions.

The International Council for Harmonisation (ICH) has published a presentation related to the M4(R4) guideline, which provides updated guidance on common technical requirements for registration applications for human pharmaceuticals.

The International Council for Harmonisation (ICH) has made the MedDRA MC Rules of Procedures available on its website, outlining procedures related to medical terminology and adverse event reporting.

The International Council for Harmonisation (ICH) has published its 2017 work plans, outlining the activities and priorities for both ICH and MedDRA throughout the year.

The International Council for Harmonisation (ICH) has published a Step 4 presentation regarding Q3C(R6), providing updated guidance on impurities in new drug substances.

The International Council for Harmonisation (ICH) is undertaking a reflection on the “GCP Renovation” initiative, which includes modernizing ICH E8 guidelines and subsequently renovating ICH E6 (Good Clinical Practice) guidelines to ensure alignment with current scientific advancements and regulatory expectations.

The ICH Q3C(R6) guideline, which addresses impurities in new drug substances, has reached Step 4 of the ICH process, indicating it is nearing finalization and potential adoption by regulatory bodies worldwide.

The ICH E6(R1) Integrated Addendum, which provides updated expectations for the conduct of clinical trials, has reached Step 4 of the ICH process, indicating it is nearing finalization and potential adoption by regulatory authorities worldwide.

The ICH Q11 draft Q&A document has advanced to Step 2b of the ICH process, signifying a public consultation phase for feedback on questions related to developing quality attributes and manufacturing processes for drug substances and products.

The ICH MedDRA Management Board meeting in Osaka, Japan, November 2016, focused on ongoing and future activities related to the maintenance of the Medical Dictionary for Drug Regulatory Affairs (MedDRA) terminology.

The ICH Assembly meeting in Osaka, Japan, November 2016, resulted in decisions regarding the progress of various guideline developments and strategic priorities for the organization.

The ICH E11(R1) draft guideline on nonclinical evaluation of juvenile formulations has reached Step 2b in the ICH process, indicating that it is now open for public consultation and refinement by expert groups.

The International Council for Harmonisation (ICH) is developing a new guideline, M9, focusing on the use of the Biopharmaceutics Classification System (BCS) to support biowaiver decisions for drug products.

The International Council for Harmonisation (ICH) is developing a new guideline, M10, focused on bioanalytical method validation to harmonize requirements and improve the quality of data generated in clinical trials.

The International Council for Harmonisation (ICH) has released training modules 8 and 9, focusing on material identification and control strategies within the Q3D guideline for elemental impurities.

The ICH M4(R4) guideline, which addresses common technical requirements for registration applications for human pharmaceuticals, has reached Step 4 of the ICH process, indicating it is nearing completion and potential adoption by regulatory authorities.