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Jun 17, 2019

Significant advancements in global harmonization efforts at ICH’s largest biannual meeting to-date
Sixteen Members and twenty-eight Observers met in Amsterdam

ICH’s global constituency further grew in Amsterdam, with ICH Assembly approval of four new Regulatory Observers: ANMAT, Argentina; CPED, Israel; JFDA, Jordan and SFDA, Saudi Arabia, bringing the total number of ICH Observers to thirty-two.

At the meeting, the Assembly reviewed the excellent progress made by ICH Working Groups both at and prior to the meeting, approved new areas for harmonisation, and took decisions in support of the recognized importance of training in ensuring a globally consistent approach to ICH Guideline implementation.

In Amsterdam, the Assembly also welcomed a new Assembly Vice Chair, with the election of: Dr. Celia Lourenco (Health Canada, Canada) succeeding Dr. Petra Doerr (Swissmedic, Switzerland) for a 6 months term until November 2019.

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ICH E8 under revision
The ICH Guideline “General Considerations for Clinical Trials” is under revision and has been issued for public comments

ICH is proposing a modernization of ICH E8 in order to incorporate the most current concepts achieving fit-for-purpose data quality as one of the essential considerations for all clinical trials. The revision would propose to: identify a basic set of critical-to-quality factors that can be adapted to different types of trials to support the meaningfulness and reliability of trial results and to protect human subjects; address a broader range of trial designs and data sources; and provide an updated cross-referencing of all other relevant ICH Guidelines that should be referred to when planning clinical studies.

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RWD & RWE in FDA submissions
New Draft Guideline on Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics

This guidance is intended to encourage sponsors and applicants who are using real-world data (RWD) to generate real-world evidence (RWE) as part of a regulatory submission to FDA to provide information on their use of RWE in a simple, uniform format. FDA will use this information for internal tracking purposes only. This guidance applies to submissions for investigational new drug applications (INDs), new drug applications (NDAs), and biologics license application (BLAs) that contain RWE used to support regulatory decisions regarding safety and/or effectiveness.

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FDA Report on Pharmaceutical Quality
Product Quality of Products marketed in the USA

The Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration (FDA) monitors the quality of CDER-regulated drugs legally marketed in the U.S.A quality drug is consistently safe and effective, free of contamination and defects. Patients and consumers expect quality drugs with every dose they take. The ‘State of Pharmaceutical Quality’ is a yearly snapshot of the pharmaceutical manufacturing industry’s ability to deliver quality pharmaceutical products.

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EMA Guideline on the quality requirements for drug-device combinations
Documentation expected for Drug-Device Combinations (DDCs)

In recent years there has been an increase in the number of scientific advice requests and marketing authorization applications (MAAs) where a medicinal product incorporates, either in an integral or non-integral manner, a medical device/medical device component (hereafter, both terms are called “device(s)”, for the use of the medicine. The availability of commercialized devices with automated functions is increasing and this may benefit patients with regular and long-term dosing requirements in an outpatient setting, either by self-administration or with the support of a professional or lay caregiver. This reduces the burden on patients and on health care systems.

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China to implement new regulation for on-site inspections at the clinical sites and manufacturing facilities
National Medical Products Administration (NMPA) released “Regulations for on-site inspections at the clinical sites and manufacturing facilities” for public comment

For sponsors that have submitted drug applications to the NMPA, on-site inspections will look into the pre-clinical and clinical studies and manufacturing processes conducted in China. The purpose is to confirm all the records are Attributable, Legible, Contemporaneous, Original, Accurate and Complete (ALCOAC criteria) as well as reliable, secure and accessible. There will be Extended Inspections that focus on manufacturing sites of APIs, excipients and packaging materials and the vendors as well as third party service providers.

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China to stipulate the accountabilities of Marketing Authorization Holder (MAH)
China released the “Revision of the Drug Administration Law of the People's Republic of China” for public comment

The Revision highlights the accountabilities of MAH:

1) MAH is held accountable for the pre-clinical and clinical trials, manufacturing and distribution, post-marketing research, as well as monitoring, reporting and follow-up of adverse events (AEs).

2) MAH needs to establish a Quality Management System (QMS) and appoint an independent responsible quality management personnel.

3) MAH needs to sign agreements with third party service providers that are involved in the drug manufacturing, distribution, storage and shipment to ensure these service providers have the robust capabilities of quality assurance and risk management.

4) MAH needs to implement risk management actions for drugs approved with conditions and complete the related studies by the pre-defined timeline.

5) MAH can license out the drug registration certificate and specify receiver’s obligations.

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