GMP News - Regulatory Affairs

19.12.23

Medical Cannabis - FDA's Perspective on Research and Drug Development

In addition to the recently published FDA guideline on Quality Considerations for Clinical Research with Cannabis the FDA now published an article to assist researchers with developing cannabis-derived product (CCDP) clinical research programs.

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19.12.23

FDA issues final Guidance on Benefit-Risk Assessment

The U.S. Food and Drug Administration (FDA) published the final guidance on Benefit-Risk Assessment. According to the agency, the intent of the guidance is to clarify how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions.

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07.12.23

First Electronic Product Information (ePI) for Human Medicines

The EMA recently announced that the Heads of Medicines Agencies (HMA), the European Commission (EC) and the EMA have published for the first time electronic product information (ePI) for selected human medicines harmonized across the European Union (EU). Does this mean the end of the printed package leaflet?

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07.12.23

Clinical Trials Regulation - Version 6.6 of the Q&As

The European Commission (EC) published an updated Version 6.6 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation (CTR). Amongst others, a new question on radiopharmaceuticals has been added.

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07.12.23

FDA issues draft Guidance on Confirmatory Evidence of Clinical Trials

The Confirmatory Evidence guidance supplements and expands the recommendations in the 2019 Substantial Evidence of Effectiveness draft guidance by providing further detail on the use of data drawn from one or more sources (e.g., clinical data, mechanistic data, real-world data).

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29.11.23

EMA: Q&A documents on the topic of "Centralised procedures" revised

In September and November 2023, the "Questions & Answers (Q&A)" documents relating to centralised authorisation procedures were revised once again and published on the website of the European Medicines Agency (EMA). The Q&A catalogues, which can be used by marketing authorisation holders and applicants for centralised procedures, provide answers to possible questions at different stages of the centralised marketing authorisation application.

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28.11.23

New Version of Quick Guide for Sponsors

The European Commission has published a new Version 3 of the Quick Guide for Sponsors. The revised guide provides clarifications on the submission of the IMPD-Q (Investigational Medicinal Product Dossier - Quality) for the IMP manufacture.

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28.11.23

EMA launches Website for accelerating EU Clinical Trials

The EMA has launched a dedicated website for the Accelerating clinical trials in the European Union (ACT EU) initiative.

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28.11.23

EMA releases Youtube Videos of Workshop on Real World Data

The European Medicines Agency (EMA) held a workshop in June on the quality of Real World Data (RWD) and its use to demonstrate Real World Evidence (RWE). In the meantime, Youtube video recordings of both days have been published.

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21.11.23

News on CEP 2.0: Specifications

The EDQM has once again published further information on its website with regard to the "CEP 2.0". The presentation and content of section 3.2.S.4.1 Specification are now discussed and explained.

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02.11.23

EMA revises Guidance on Development, Production, Characterization and Specification for Monoclonal Antibodies and related Products.

In the context of technical and scientific developments in the field of certain products containing monoclonal antibodies, the EMA is revising its guidance document "Development, production, characterisation and specifications for monoclonal antibodies and related products" and other related documents.

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02.11.23

Warning Letter to Swiss Manufacturer of Homeopathic Eye Drops

Among other things, a Swiss pharmaceutical manufacturer received a Warning Letter from the FDA due to inadequate 100% visual inspection of its eye preparations. But the conduct of media fills and the completeness of laboratory results were criticised as well.

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26.10.23

Revised USP Chapter <660> Glass Containers

Following the previously issued draft for USP General Chapter <660> Containers – Glass, the final version of the chapter was published and made official on 1st October 2023. In particular, the revision to General Chapter <660> changed the "composition based" glass type definition to one that is "performance based".

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26.10.23

Quality Attributes for Ophthalmic Drug Products

The FDA published a draft guidance that discusses quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye.

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26.10.23

EMA Publishes revised CTIS Transparency Rules

The EMA has endorsed the revised transparency rules for the EU Clinical Trials Information System (CTIS). According to the agency, the simplifications introduced will give access to clinical trial information to stakeholders, patients and healthcare professionals in a faster and more efficient way.

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