Regulatory Focus™

More than two years after opening public consultations on the guidelines, the European Medicines Agency (EMA) on Tuesday adopted two International Council for Harmonisation (ICH) guidelines, the ICH E9(R1) addendum on estimands and sensitivity analysis in clinical trials and ICH S5(R3) on reproductive toxicology, with both guidelines set to take effect on 30 July 2020.

The International Council for Harmonisation (ICH) recently announced that its new draft E2D(R1) guideline on post-approval data and individual case safety reports (ICSRs) has been released for public consultation.

With a focus on modernization, the International Council for Harmonisation (ICH) on Thursday released for public consultation a draft version of its guideline E8(R1) on the general considerations for clinical trials.

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we're reading from around the web. This week, FDA issued new guidance on its Prescription Drug User Fee Amendments (PDUFA VII) program and released the final version of the International Council for Harmonisation's (ICH) Q9(R1) Quality Risk Management guideline.

The International Council for Harmonization (ICH) recently announced that the E8(R1) guideline on general considerations for clinical studies had reached Step 4 and is awaiting sign-off by regulators. The widely anticipated guideline modernizes the design, conduct and reporting of clinical trials by adopting quality by design principles. The guideline incorporates 'current concepts achieving fit-for-purpose data quality.”

Pharmaceutical industry groups in the US suggested the International Council of Harmonization's (ICH) Q9(R1) guideline on risk management be revised to better reflect the principles of the ICH Q10 guideline on effective quality management systems. Industry groups in the US and the Europe also recommended that forthcoming training materials provide more concrete examples showing how specific risk management principles can be applied.

The proposed revisions of the International Council of Harmonization's (ICH) Q9 (R1) guideline on risk management should be better aligned with medical device quality risk standards as well as international standards. Further, a firm's information technology (IT) program should be subject to the same level of risk controls as other areas within an organization, representatives of the pharmaceutical industry said in their comments on the update.

The International Council for Harmonization (ICH) has issued ICH E9 (R1) training materials meant to improve the planning, design, analysis and interpretation of clinical trials by defining suitable estimands.

The International Council on Harmonization (ICH) has issued training materials to complement its revised Q9(R1) guideline on quality risk management aimed at assisting the pharmaceutical industry in navigating the newly revised guideline.

The International Council for Harmonisation (ICH) recently announced that its S1B(R1) addendum outlining a 'weight of evidence” (WoE) approach to assess the human carcinogenic risk for certain pharmaceuticals in lieu of conducting a two-year rat study has reached Step 4 and is awaiting sign-off by regulators.

The pharmaceutical industry has expressed a need for greater clarity regarding the timeline for converting quality information for existing drug and biologics dossiers to the common technical document (CTD) format described in the International Council for Harmonisation's (ICH) M4Q(R2) guideline.