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Mar 31, 2019

New draft FDA Q&A guide on Risk-based Monitoring
USFDA asks for feedback during the next 60 days

This document provides guidance on risk-based approaches to monitoring investigational studies of human drug and biological products, medical devices, and combinations thereof. This guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results. This guidance expands on the guidance for industry Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring (August 2013) (the RBM guidance) by providing additional guidance to facilitate sponsors’ implementation of risk-based monitoring.

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Final FDA Guideline for the inclusion of Adolescent Patients in Oncology Trials
USFDA finalized their guidance on Adolescent Patients participating in Oncology Trials

The purpose of this guidance is to provide the pharmaceutical industry, clinical investigators, and institutional review boards with information to facilitate the inclusion of adolescent patients (for purposes of this guidance, defined as ages 12 to 17) in relevant adult oncology clinical trials. FDA recommends the inclusion of adolescent patients in disease- and target-appropriate adult oncology clinical trials to enable earlier access to investigational and approved drugs for adolescent patients with cancer. Topics that are discussed in this guidance include the following:

  • Appropriate criteria for the inclusion of adolescent patients in adult oncology clinical trials at various stages of drug development
  • Dosing and pharmacokinetic and pharmacodynamic evaluations
  • Safety monitoring
  • Ethical considerations

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New FDA Draft Guidance on minimum Age of Pediatric Patients
New Cancer Clinical Trial Age Eligibility Criteria – Feedback expected within the next 60 days

This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products2 regulated by CDER and CBER for the treatment of cancer. Specifically, this guidance includes recommendations regarding the inclusion of pediatric patients (i.e., children and adolescents). This guidance is intended to assist stakeholders, including sponsors and institutional review boards (IRBs), responsible for the development and oversight of clinical trials.

A clinical trial’s eligibility criteria (for inclusion and exclusion) are essential components of the trial, defining the characteristics of the study population. Because there is variability in investigational drugs and trial objectives, eligibility criteria should be developed taking into consideration the mechanism of action of the drug, the targeted disease or patient population, the anticipated safety of the investigational drug, and the ability to recruit trial participants from the patient population to meet the objectives of the clinical trial. However, some eligibility criteria have become commonly accepted over time or used as a template across trials without clear scientific or clinical rationale. Unnecessarily restrictive eligibility criteria may slow patient accrual, limit patients’ access to clinical trials, and lead to trial results that do not fully represent treatment effects in the patient population that will ultimately use the drug. Broadening cancer trial eligibility criteria can maximize the generalizability of trial results and the ability to understand the therapy’s benefit-risk profile across the patient population likely to use the drug in clinical practice without jeopardizing patient safety. Early evaluation and development of potentially effective drugs, particularly targeted drugs, in pediatric patients may provide information on safe and effective use, therefore reducing risks associated with off label use, and accelerate the development of effective, innovative therapies for pediatric patients.

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China to change the requirements for packaging materials and containers that have a direct contact with drugs
Several Regulations were changed to address this topic

The State Council issued the amendment of several regulations in which No.39 is to delete the sentence “and get approved and registered by the Drug Regulatory Authority” from the original Article 43, Paragraph 1 of “The Drug Administration Law of the People's Republic of China”, “Packaging materials and containers that contact drugs directly must meet the requirements for medicinal use and the standards for ensuring human health and safety, and get approved and registered by the Drug Regulatory Authority.”

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EMA issues Brexit-related guidance for companies
Page on special Brexit related regulation updates – will be updated on a regular basis

The European Medicines Agency (EMA) and the European Commission are providing guidance to help pharmaceutical companies responsible for both human and veterinary medicines prepare for the United Kingdom's (UK) withdrawal from the European Union (EU), a process known as 'Brexit'.

This aims to ensure that companies are ready to take the necessary steps to enable undisrupted supply of their medicines in the EU for the benefit of patients, based on the assumption that the UK will become a third country.

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EU and Switzerland to improve information-sharing on good manufacturing practice through use of the EudraGMDP database
Swissmedic feeds information into the EU database

The Swiss Agency for Therapeutic Products (Swissmedic) has started in 2019 to enter information on Good manufacturing practice (GMP) compliance as well as on manufacturing authorizations related to Swiss manufacturers into the European Union’s EudraGMDP database. This applies for all new or renewed manufacturing authorizations and the related GMP-certificates issued using new templates (similar to those of EMA). This will allow replacing the current practice of issuing paper documents, i.e. GMP certificates for certain regulatory procedures and therefore should lead to easier information-sharing and efficiency gains for all stakeholders.

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How to make submissions to the MHRA if the UK leaves the EU with no deal
Recorded webinars on the issue

The MHRA is making preparations to ensure that in the event the UK leaves the EU with no deal, regulatory submissions are still feasible.

If the UK leaves the EU with no deal, the UK would no longer be part of the EU medicines and medical devices regulatory networks. Submissions related to human medicines would need to be submitted directly to the MHRA.

There is a contingency program in place to deliver new systems and processes should the UK lose access to the current EU IT systems. Where feasible, they are trying to minimize additional administrative burdens and are trying to make any changes as simple to use as possible.

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