EUDAMED - Current Status of the Database for Medical Devices
The European Commission published Questions & Answers on 26 May 2021, the day of application of Regulation 2017/745 for medical devices. The Questions & Answers are related to the requirements and tools for the safety of medical devices, including EUDAMED.
EU-Switzerland: MRA for Medical Devices no longer valid
Due to the new EU Regulation on Medical Devices (2017/745) and failed negotiations between Switzerland and the EU, the corresponding Mutual Recognition Agreement (MRA) will become obsolete. This has far-reaching consequences.
International Inspections: TGA and the Management of GMP Compliance Signals
The Australian Therapeutic Goods Administration (TGA) has published a guidance on the management of so-called GMP compliance signals for domestic and foreign manufacturers of medicinal products and biological products.
The US FDA recently issued a draft guidance to help manufacturers implement ICH Q12 by explaining how to submit ECs. In addition, the agency provides general guidance about the elements that are considered ECs for the device constituent part of combination products.
The FDA adopted the ICH Q12 Guideline for post-approval change management. The guideline is intended to complement the existing ICH Q8 to Q11 Guidelines. It is composed of a Core Guideline and two Annexes with practical examples for ECs and PACMPs.
FDA updates Q&A Guidance on Inspections and Applications
After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers Guidance for Industry" with some further clarifications.
ICH E6 GCP Guideline: Updated GMP for IMP Principles
The ICH has published a draft version of the updated principles that are currently under development by the ICH E6(R3) EWG. Amongst others, the updated version includes revised and expanded principles regarding GMP for IMPs.