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.
The U.S. Food and Drug Administration (FDA) issued a discussion paper on "Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products." In particular, the FDA wants to receive feedback on the key areas in the context of AI/ML, including Good Machine Learning Practice (GMLP).
The U.S. Food and Drug Administration (FDA) has published a Form 483. During an inspection at an Indian drug manufacturing side, several CGMP violations were documented. These concerns, among others, Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, where results were invalidated by retesting the batches without a scientifically justified root cause.
In March 2023, the ECA offered the Live Online Training "How to register APIs in Brazil". With regard to Brazil's Registration procedures for APIs, a set of the most important questions raised during the training and the respective answers provided by the speakers Ms Marieke van Dalen, Global Regulatory Specialist, Aspen, The Netherlands, and Ms Susan Swiggers, Customer & Regulatory Support Officer, Aspen, The Netherlands, are listed in the following.
Good Manufacturing Practice is referred to as GMP in the EU, in almost all PIC/S countries and at WHO. The FDA, however, refers to it as CGMP. But what exactly is behind it? The FDA has published a paper on this.
If you are a non-EU based company exporting drug products into the EU, it is essential to understand the role of a QP. It's also helpful to understand all other EU-GMP requirements to be better prepared for inspections.
The first version of the "Sharing Drug Substance M7 information to HA and MAH: "How to do" document -Interpretation of the ICH M7 guideline and other relevant guidelines with regard to M7 data sharing" and the associated templates were finalised in March and April 2023 and are now available on the APIC website.
In October 2022 you could already find out in a news that the FDA does not accept the manufacture of medicinal products on equipment that is also used to manufacture non-pharmaceutical products. But what are the consequences if the FDA does discover such manufacturing?
Since the beginning of May 2023, the chapter <2> Oral "Drug Products - Product Quality Tests", which is part of the heading "General Tests & Assays", has been published for comments on the website of the Pharmacopeial Forum of the USP. Comments and remarks on this draft, which is based on the previous version from August 2020, can be submitted until 31 July 2023.