The pharmaceutical industry would like the International Council for Harmonization (ICH) to clarify dosing information for rifampin and requests additional information on the use of biomarkers as a type of drug-drug interaction study (DDI), while the Pharmaceutical Research and Manufacturers of America (PhRMA) and Pfizer want more flexibility in developing a DDI strategy.   The comments were made in response to the US Food and Drug Administration’s (FDA) call for feedb...

The US Food and Drug Administration’s (FDA) draft guidance on risk management plans (RMPs) has overstepped the agency’s statutory bounds in requiring manufacturers of active pharmaceutical ingredients (APIs) as well as prescription drug manufacturers to submit risk management plans (RMPs) to avert drug shortages.   This requirement could impose the very drug shortages it is designed to prevent, instead of just targeting those products at risk of drug shortage, pharmace...

Pharmaceutical industry groups praised certain aspects of the International Council for Harmonisation (ICH) draft Q14 and Q2(R2) guidelines yet had questions on how enhanced knowledge on analytical methods should be conveyed in regulatory submissions and whether smaller companies would have the necessary resources to invest in the enhanced approach in Q14.   Other groups had questions related to the use of multivariate modeling in analytical method development. In addi...

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 document contains several changes from the Step 2 guideline released in May 2021. (RELATED: To speed drug development, ICH proposes reducing rat carcinoge...

Welcome to the June issue of RF Quarterly in which global regulatory experts write about Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), medical device regulations in China’s National Medical Products Administration (NMPA), and a personal reflection on 3 decades at the International Council for Harmonisation (ICH). Also included are articles on the development of clinical trial disclosure requirements, expedited pathways, and the De Novo pathway and the Final Ru...

Feature articles in June examined food safety in China, US Food and Drug Administration (FDA) guidance on supply chain disruptions, possible updates to the US Dietary Supplement Health and Education Act (DSHEA), and FDA and Federal Trade Commission (FTC) regulation of dietary supplements intended for treating or preventing certain mental health disorders.   Safety, disruptions, and responsive policy  China has improved its overall food safety situation significant...

This article reviews the changes in China's national food safety control system and update on national food safety standard system and describes the country's unique regulations and requirements for the regulatory control of infant formula, health foods (functional foods), and food for special medical purposes (FSMP). Keywords – infant formula; food for special medical purposes; food regulatory control; food safety; food standards   Introduction Since the m...

The International Council for Harmonisation (ICH) announced it has reached several milestones over the past year, including advancing guidelines on validating analytical procedures for testing pharmaceuticals and extrapolating adult clinical trial data to the pediatric populations.   The ICH announcement follows its 21-25 May meeting in Athens, Greece which was held in a hybrid format. The meeting included seven working groups, as well as the ICH Management Committee...

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 European Medicin...

The International Council for Harmonization (ICH) on Tuesday released a draft ICH E11A guideline that establishes a framework for extrapolating drug development data from adult trials to the pediatric population.   “This new ICH guideline aims to promote international harmonization of methodologies and strategies to incorporate paediatric extrapolation into overall drug development plans and to improve the speed of access to new drugs for paediatric patients, while l...

The International Council for Harmonization (ICH) on Thursday issued two draft guidelines that should make it easier for manufacturers to switch analytical methods for testing medicines postapproval and are aimed to promote more robust analytical processes.   The Q14 guideline would harmonize the scientific approaches for analytical procedures development while the Q2(R2) document covers the validation principles for the use of analytical procedures such as near-infrar...

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 238-page guide is meant to accompany an earlier addendum that presents a structured framework to link trial objectives to a suitable design; the addendum took effect in 30 July 2020 (RELATED:  ICH E9(R1) and S5(R3) to Take Effect in EU by End of July ...