The European Medicines Agency had launched a public consultation on the revision of the transparency rules of the Clinical Trials Information System (CTIS). Stakeholders were invited to send their comments via an online form by end of June 2023.
One of the most important documents in the context of medical device regulation is the technical documentation. Updated as version 2, a helpful position paper from the Team Notified Body provides assistance in this regard as a best practice guide.
The topic of artificial intelligence/machine learning (AI/ML) is currently all around. The FDA has also taken up AI/ML and published various draft guidance documents. A current draft is aimed at manufacturers of medical devices that contain software.
An EU Regulation laying down specific rules for medicinal products for human use for Northern Ireland has been published in the Official Journal of the EU. It mainly concerns importation into NI and safety features.
In June, the VDI published the new guideline 6022 Blatt 1.1 as a draft for comment. The new document is intended to expand on the existing Guideline 6022 Blatt 1, which describes the overall hygiene assessment of ventilation and air-conditioning systems.
The European Medicines Agency (EMA) has published on its website the detailed minutes of the Herbal Medicinal Products Committee (HMPC) meeting from 13-15 March 2023. In the meeting, the HMPC discussed some issues known to cause difficulties in procedures and ideally to be addressed during the current GACP revision.
In 2005, the HMPC prepared the "Public statement on the use of herbal medicinal products containing estragole". Now, several footnotes were added in Table 1 of the document regarding the provided examples of estragole-containing plants.
The EDQM has published a new edition of the Guide for the elaboration of monographs on herbal drugs and herbal drug preparations. The Guide provides general guidance on the structure of Ph. Eur. monographs of herbal drugs and herbal drug preparations and on the information to be included in them. In addition, principles for the preparation and revision of herbal monographs are explained.
More than 60 participants attended the ECA Webinar "GDP Update 2023" in March. Many interesting aspects were discussed in the Q&A session. In total, about 20 questions were addressed to the speaker, Dr. Christian Grote-Westrick, which he answered in writing afterwards. We have compiled a selection of the questions and answers for you. You can read Part 3 here.
The MHRA has announced a "long-term solution" of the Windsor Framework for the supply of medicines into Northern Ireland, effective from January 1, 2025. One key issue concerns the packaging and labelling of medicinal products.
The ICH E6(R3) draft Guideline on Good Clinical Practice (GCP) is now available for public consultation. It intends to encourage the use of innovation and technologies that have the potential to make clinical trials more efficient.
The FDA is requesting feedback on factors the agency should consider when reviewing proposed modifications to a risk evaluation and mitigation strategy (REMS) that are prompted by or related to changes in third-party vendors, also known as REMS administrators.
When planning cleanrooms and their HVAC systems, questions often arise regarding "recovery time" and "clean-up phase". Are these different requirements, or are they the same? Do these only apply to sterile or also to non-sterile products? And do they have to be measured in operation or at rest?
In April 2023, the Questions & Answers documents related to centralised marketing authorisation procedures were revised and published on the European Medicines Agency (EMA) website. The Q&As, which can be used by marketing authorisation holders and applicants of centralised procedures, provide answers to potential questions at different stages of the centralised marketing authorisation application process.
The European Medicines Agency (EMA) has opened a public consultation on a reflection paper that discusses key concepts for single-arm clinical trials (SATs) for new therapies. According to the agency, this is the first guidance issued by an international medicine regulator articulating the considerations and challenges associated with this type of clinical trials.