The European Medicines Agency (EMA) has produced ground rules for extending the role of national competent authorities (NCAs) in post-authorisation procedures. Publication of the rules is in response to requests from some NCAs to extend the remit of multinational assessment team (MNAT) beyond pre-authorisation activities.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) is currently experiencing a high volume of submissions so you may encounter some delays with some applications.
Conditional marketing authorisations (CMAs) aim to provide patients with an unmet medical need early access to new medicines. This EMA report presents the positive impact CMAs have had in improving public health. It has been produced in response to the European Commission’s Expert Group on Safe and Timely Access to Medicines for Patients (STAMP), which wanted to understand the experience of conditional marketing authorisations in the EU.
This guidance should help sponsors of investigational new drugs and new drugs for approval evaluate whether their new drug product has abuse potential.
The US Food and Drug Administration (FDA) has issued draft guidance on demonstrating biosimilar interchangeability.
From 1st July 2017, manufacturers, authorised representative and distributors of Class III and implantable devices (except custom-made devices) must communicate to ANSM a Summary of the Characteristic of the Device (SCD) when placing a device on the market in France. The SCD must be send by email to ANSM with the communication form for placing the device on the market.
The French Notified Body LNE/G-MED has issued its calendar for implementation of the MEDDEV 2.7.1 for Clinical Evaluation, published in April 2016 in their audit requirements.
The European Medicines Agency (EMA) has published a summary of its key recommendations for marketing authorisations of new medicines and the safety monitoring of approved medicines in 2016.
The US Food and Drug Administration (FDA) has issued a new draft guidance on how to prepare a Pre-Request for Designation (Pre-RFD). The Pre-RFD process is means of obtaining informal, non-binding feedback on the classification of a human medical product as a drug, device, biological or combination product and understanding which of the agency’s review centers will be responsible for reviewing and regulating the product, should it be a combination product. Specifically, this guidance explains the Pre-RFD process at the Office of Combination Products (OCP) and helps a sponsor understand the type of information to provide in a Pre-RFD. In fact, the content and format of a Pre-RFD is described in some detail.
With the number of endpoints in studies increasing and this leading to an increased chance of making incorrect conclusions on a drug’s effectiveness, the US Food and Drug Administration (FDA) released chunky, detailed draft guidance on the analysis and interpretation of study results with multiple endpoints. The guidance seeks to clarify when and how multiplicity due to multiple endpoints should be managed to avoid concluding that a drug is beneficial when it is not, something that is of primary concern to the agency. The guidance presents various strategies for grouping and ordering endpoints for analysis and applying some well-recognised statistical methods for managing multiplicity within a study in order to control the chance of making erroneous conclusions about a drug’s effects.