GMP News

EMA starts Review of Transparency Rules for the CTIS

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.

More

How to create a Notified Body compliant Technical Documentation?

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.

More

Dealing with Artificial Intelligence in the Context of the further Development of Software in Medical Devices

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 The FDA has also taken up AI/ML and published various draft guidance documents.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.

More

Northern Ireland: EU Regulation with specific Rules published

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.

More

New VDI Guideline 6022, Blatt 1.1 published as Draft

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.

More

EMA Update on GACP Revision

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.

More

Updated Public Statement of the HMPC on HMPs containing Estragole

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.

More

New Edition of the Herbal Guide

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

Cannabis Reference Standards DAB

The amended German Pharmacopoeia (Deutsches Arzneibuch, DAB) is valid from 1 August 2023. The DAB 2023 now includes several revised texts for Cannabis reagents.

More

Abbreviations in the GDP Environment

During GDP events organised by the ECA, the wish came up to compile a list of relevant abbreviations used in the GDP environment. We have prepared such an overview.

More

GDP in the US: Update of the USP <1079> Series of Chapters on Good Storage and Distribution Practices

The United States Pharmacopeia (USP) intends to revise several chapters of the <1079> series in response to the omission of General Chapter <1118> Monitoring Devices—Time, Temperature, and Humidity.

More

Questions and Answers from the ECA Webinar "GDP Update 2023" - Part 3

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.

More

News on the Windsor Framework for Medicines Supply in Northern Ireland

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.

More

Korean MFSD publishes Revision 7 of Comparative Dissolution Test Guideline

The Korean Ministry of Food and Drug Safety (MFDS) has revised the "Guidelines for Comparative Dissolution Test". A new version dated 18 May 2023 was published.

More

ICH GCP Draft Guideline

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.

More

How to Deal with Changes to Third-Party Vendors?

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.

More

USP <88> "Biological Reactivity Tests, In Vivo" is currently also undergoing Revision

In the course of the revision of the Chapter on biological reactivity the USP has also published a draft of chapter <88> on in vivo tests. This news presents a summary of the changes.

More

Appearance as a Release Test? This is not the Way to get through an Inspection

The FDA has issued a Warning Letter to a manufacturer in the USA who has not adequately tested its drug products. And the manufacturer relied on others for supplier qualification.

More

Clean-up Phase and Recovery Time - is there a Difference?

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?

More

Inadequate Cleaning of Product-Contact Surfaces

In a Warning Letter, the FDA describes the inadequate cleaning of product-contact surfaces and the associated risk of cross-contamination at an Egyptian pharmaceutical manufacturer.

More

Updates to the EMA Q&A Documents on Centralised Procedures

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.

More

MRA: EU-US Agreement to recognise GMP Inspections for Veterinary Medicines

The Mutual Recognition Agreement (MRA) between the EU and the US will be extended to veterinary medicines. This was announced by the EU Commission in a press release.

More

MHRA announces Cooperation with seven international Partners

The U.K Medicines and Healthcare products Regulatory Agency MHRA is working on a new international recognition framework, including EMA and FDA.

More

GMP Inspection finds weak points in the GMP training system: How to (not) react

In a recent Warning Letter, the FDA criticises, among other things, an inadequate training system. How to respond to such an inspection deficiency?

More

EMA issues Reflection Paper on Demonstrating Efficacy for Advanced Therapies

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.

More

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics