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Jan 16, 2020

Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 Questions and Answers
On 15 January 2020 FDA announced the availability of the guide for industry. Comments may submit by 16 March 2020.

The purpose of this guidance is to provide information to sponsors regarding the submission of an initial pediatric study plan (iPSP), as required by section 505B(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), for oncology drugs only. Specifically, this guidance provides FDA’s current thinking regarding iPSPs for oncology drugs in light of the amendments to section 505B of the FD&C Act (also referred to as the Pediatric Research Equity Act, or PREA) made by section 504 of the FDA Reauthorization Act of 2017 (FDARA). FDA has received a number of questions on this topic and, as a result, is providing guidance in a question and answer format, addressing the most frequently asked questions.

This guidance does not contain a complete discussion of general requirements for development 28 of drugs for pediatric use under PREA or section 505A of the FD&C Act (also referred to as the 29 Best Pharmaceuticals for Children Act or BPCA).

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Mandatory use of international standard for the reporting of side effects to improve safety of medicines
On 15 January 2020 the EMA management board announced the confirmation of the mandatory use of the ISO Individual Case Report standard based on ICH E2B(R3) modalities and related ISO standard terminology.

At its December 2019 meeting, EMA's Management Board agreed to the mandatory use of a consistent international format, the ISO ICSR format, for reporting individual cases of suspected side effects in patients across the world. This follows a recommendation from EMA’s safety committee (PRAC) in October 2019. The use of the new international standard will become mandatory as of 30 June 2022 for all reporting to EudraVigilance, the European database of suspected side effects with medicines authorised in the European Economic Area (EEA).

The ISO ICSR standard is based on the ICH E2B(R3) modalities for the reporting of suspected side effects of medicines in individual case safety reports (ICSRs). Compared to the older reporting formats it improves the quality of data collected and increases the ability to search and analyse these data. This will better support regulatory authorities and companies to detect and address safety issues with medicines and therefore protect patients. In addition, the ISO standard strengthens personal data protection in the records of ICSRs collected by regulatory authorities and companies.

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IRIS guide for Parallel Distribution applicants
On 10 January 2020 EMA updated the IRIS guide for parallel distribution applicants.

This guide has been produced to help individuals using the IRIS | Regulatory & Scientific Information Management platform understand how to use the portal to submit a notification for parallel distribution.

This document is intended for Industry users who have already been granted Industry user access roles for the IRIS portal.

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Human medicines: highlights of 2019
On 9 January 2020 EMA published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use.

Innovative medicines are essential to advancing public health as they bring new opportunities to treat certain diseases. In 2019, EMA recommended 66 medicines for marketing authorisation. Of these, 30 had a new active substance which had never been authorised in the EU before. The infographic includes a selection of medicines that represent significant progress in their therapeutic areas.

Once a medicine is authorised by the European Commission and prescribed to patients, EMA and the EU Member States continuously monitor its quality and benefit-risk balance and take regulatory action when needed. Measures can include a change to the product information, the suspension or withdrawal of a medicine, or a recall of a limited number of batches. An overview of some of the most notable recommendations is also included in the document.

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Q&A on impact of EU-USA Mutual Recognition Agreement on marketing authorisation applications and relevant variations
On 7 January 2020 EMA updated how the EU-USA Mutual Recognition Agreement (MRA) affects marketing authorisation applications or variations.

In December 2019 the EMA revised how the EU-USA Mutual Recognition Agreement (MRA) affects marketing authorisation applications or variations. As the US FDA does not issue GMP certificates, applicants should submit all available documents as proof of GMP compliance for US manufacturing sites that have been previously inspected by US FDA.

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