GMP News - Regulatory Affairs

04.07.23

Interim Guidance on Protection of Personal Data & Commercially Confidential Information

Following the previously published public consultation document on Data Protection of Information uploaded in the CTIS, the EMA has now published an interim guidance. The document is available for CTIS users and provides guidance on the protection of personal data and commercially confidential information (CCI) while using CTIS.

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04.07.23

Generally Accepted Scientific Knowledge in Drug Applications

The FDA has received an increasing number of questions regarding the extent to which generally accepted scientific knowledge (GASK) may be relied on for drug or biological product approval. Therefore, the agency published a draft guidance which describes instances in which it may be appropriate to rely on GASK to meet certain nonclinical safety requirements for new drug applications.

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04.07.23

FDA's Guidance for Decentralized Clinical Trials

The FDA published a draft guidance on decentralized clinical trials (DCTs). Examples of decentralized elements include obtaining laboratory tests at a local facility rather than a research medical center or conducting a clinical follow-up visit in the trial participant's home.

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04.07.23

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.

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28.06.23

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.

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21.06.23

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.

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20.06.23

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.

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20.06.23

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.

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20.06.23

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.

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07.06.23

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.

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07.06.23

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.

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06.06.23

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.

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06.06.23

FDA Publishes Final Q&A Paper on Risk-Based Monitoring of Clinical Trials

The U.S. Food and Drug Administration (FDA) published the final Q&A paper on a risk-based approach to monitoring of clinical trials.

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06.06.23

Good Machine Learning Practice: FDA issues Discussion Paper on AI/ML in Drug Development

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).

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31.05.23

Registration of APIs in Brazil - Q&As

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.

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