What the European Medicines Agency’s qualification opinion means for electronic clinical data capture
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FDA and EMA Address Quality and Manufacturing Challenges for Breakthrough Therapies Undergoing Expedited Approval
On July 31, 2019, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published a joint report on their efforts to support the development of and expedite access to breakthrough therapies that address unmet medical needs. In addition to outlining the tools currently available to manufacturers seeking expedited approval of breakthrough therapies, the report recognizes the need for further regulatory innovation to advance emerging scientific knowledge and support timely access to…
EDPB’s Position on Clinical Trials Creates Friction with Other EU Legislation
Clinical trials in the EU include the collection of sensitive health data from patients. Trial sponsors are obliged to reconcile their respect of regulations governing data protection with regulations governing the conduct of clinical trials. The GDPR¹ could not fully harmonize these rules since this area is already heavily regulated by public health regulations that vary between EU Member States. One of the most disconcerting areas of divergence between EU Member States is the different national…
EDPB’s Position on Clinical Trials Creates Friction with Other EU Legislation
Clinical trials in the EU include the collection of sensitive health data from patients. Trial sponsors are obliged to reconcile their respect of regulations governing data protection with regulations governing the conduct of clinical trials. The GDPR¹ could not fully harmonize these rules since this area is already heavily regulated by public health regulations that vary between EU Member States. One of the most disconcerting areas of divergence between EU Member States is the…
European Commission publishes factsheet on the (in vitro) medical devices procurement ecosystem
Introduction
The European Commission has published a factsheet addressed to organisers of public tenders involving medical devices. The goal of the factsheet is to provide hospitals, clinics, ministries and competent authorities responsible for the procurement of (in vitro) medical devices with guidance concerning Medical Device Regulation (MDR) and the In Vitro Device Regulation (IVDR).
This factsheet is one of several guidance documents published by the European Commission to clarify points and answer questions regarding the…
The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare allergic diseases
Introduction
On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines concerning medicinal products containing allergens are currently applicable. They provide guidance for the clinical development and quality control of medicinal products containing allergens. All of these guidelines start from the premise that the population of the clinical trial is large enough to gather adequate data.
The goal of…
European Commission publishes factsheet on medical devices and in vitro medical devices for non-EU and non-EEA competent authorities
Introduction
The European Commission has published a factsheet addressed to competent authorities of third countries. This factsheet is one of several guidance documents published by the European Commission to clarify points and answer questions regarding the implications of the Medical Device Regulation (MDR) and the In Vitro Medical Device Regulation (IVDR).
The factsheet is intended to facilitate the import into the EU and export of medical devices from the EU during the transition period.…