News

Last weeks round-up; 21-25 October 2019

published 28 Oct 2019

Authors: Fiona Windsor

NEW REAL REPORT: EMA’S IRIS PLATFORM – ONE YEAR ON

The EMA online IRIS platform for orphan drug designation applications and post-approval activities such as orphan annual reports and orphan transfer applications was launched in 2018. A year after its use became mandatory, Real Regulatory Consultants have written an article that discusses the practicalities, from an industry perspective of using IRIS. The article also discusses the initial set-up and administration steps that should be followed before a sponsor can successfully use IRIS for their orphan submissions. https://lnkd.in/dTmgRqd

RECOMMENDATIONS ON ELIGIBILITY TO PRIME SCHEME

Following its October 2019 meeting, EMA has issued details of its recommendations on applications to the PRIME scheme and updated cumulative statistics on levels of grant vs denials. The latter by far still comprising the largest proportion. Further information can be found at this link. https://lnkd.in/dt25vzN

EMA ISSUES UPDATED Q&A ON MDR

EMA has just issued an updated Q&A on implementation of the medical devices and in-vitro diagnostic medical devices Regulations. Additions are conveniently highlighted in red on the document found on the link below and in particular relate to the effect of the MDR on DDC (drug device combination) products. https://lnkd.in/dizS5Jk

EMA CERTIFICATES THROUGH URGENT AND STANDARD PROCEDURES

As a consequence of the Agency’s move to the permanent building, there will be changes to the timelines for requesting and production of Certificates of Pharmaceutical Products between November 2019 and January 2020. Further specific information can be found in the link below; https://lnkd.in/dgE7Zt4

EMA ENHANCING CONSISTENCY IN WORDING OF THERAPEUTIC INDICATIONS

EMA’s human medicines committee (CHMP) has developed a paper to strengthen consistency when defining therapeutic indications in the product information of medicines. It outlines key elements for assessors to consider when evaluating the therapeutic indications proposed by the applicant. In this context, the paper also takes into account some of the needs of healthcare decision-makers such as healthcare professionals and health technology assessment (HTA) bodies. A link to the paper is detailed below; https://lnkd.in/davVvvZ

EMA GUIDELINE ON GCP SPECIFIC TO ATMPs

Clinical trials with ATMPs should take into account the specific characteristics of these medicinal products, as well as the potential risks to subjects, investigator’s team and others. While some ATMP specific considerations are explained in this Guideline, it is stressed that these are non-exhaustive and further information should be considered as laid down in the Regulation (EU) No 536/2014.4. https://lnkd.in/eYwABud

EUROPEAN COMMISSION ISSUES A SITE SUITABILITY TEMPLATE FOR CLINICAL TRIAL SPONSORS

A new site suitability template has been published by the EC to help clinical trial sponsors in applications under the EU’s incoming clinical trial regulation (CTR). The new template aids sponsors to explain the suitability of personnel, facilities, equipment and the site to handle the nature and use of the investigational products involved in a clinical trial. The template and other documents relevant to the CTR can be found in the below link. https://lnkd.in/dHJuRqB