GMP News - Regulatory Affairs

06.05.20

New Ph. Eur. Chapter on Essential Oils

The general Ph. Eur. monograph on Essential Oils has been published for comment in the recent issue of Pharmeuropa together with a proposed new Ph. Eur. chapter 5.30. Monographs on essential oils.

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29.04.20

New EU/EMA planned Actions in the Context of the COVID-19 Pandemic

The European Medicines Agency EMA has published three press releases on current EU/EMA activities in the context of the COVID-19 pandemic.

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01.04.20

Brexit: New Notice to Stakeholders

EU has published a new Notice to Stakeholders on the withdrawal of the UK which summarises the most important aspects in three parts.

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30.03.20

Deadline Extended: EMA Informs about New Deadline for Risk Assessment on Nitrosamines

The European Medicines Agency, EMA, as well as the EDQM have extended their deadlines for submitting risk evaluations for Nitrosamine Impurities in medicinal products by the Marketing Authorisation Holders.

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11.03.20

EU implementation of ICH Q12

Following the adoption of the ICH Q12 Guideline in November 2019 the EMA recently published the ICH Q12 Step 5 Guideline and its annexes - together with an Explanatory Note.

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27.02.20

ICH M9 BCS-based biowaivers and Q&A´s adopted

The ICH M9 Guideline and the corresponding Q&As reached Step 4 of the ICH Process in November 2019.

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27.02.20

QbD for TDS: FDA´s new draft guidance

The FDA published a draft guideline "Transdermal and Topical Delivery Systems - Product Development and Quality Considerations".

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19.02.20

CBD is controlled as a medicine in Finland

The Finnish Medicines Agency (Fimea) recently stated that Cannabidiol (CBD) is controlled as a medicine in Finland.

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18.02.20

Clinical Trials Regulation Questions & Answers Version 2.3

The European Commission (EC) published an updated Version 2.3 of the Questions & Answers relating to the Clinical Trials Regulation.

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18.02.20

How to authorize a Combination Product in the USA?

In the USA, combination products are regulated independantly.  A draft document from the FDA entitled "Principles of Premarket Pathways for Combination Products" describes the ways in which marketing authorisations are granted in the USA and how the various Centers interact.

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18.02.20

ICH E9 Addendum adopted

The ICH E9(R1) Addendum to defining the appropriate Estimand for a Clinical Trial / Sensitivity Analyses reached Step 4 of the ICH Process.

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18.02.20

EMA/CHMP publishes new Q&A Document on Comparability Considerations for ATMPs

A document on the topic of comparability in the context of Changes and Variations at ATMP, published in December by the EMA, respectively the CAT, completes the series of guidelines and assistance around ATMP.

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18.02.20

Guide on the Use of Type V Drug Master Files for Combination Products

In October 2019, the FDA issued guidelines in a draft document regarding the use of a Type V Drug Master File (DMF). In this document, information can be made available to the CDER (if it is in charge of the (project) approval procedure) concerning the medical device proportion of a combination product.

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17.02.20

New GMP Guidance for Marketing Authorisation Holders

After long discussions, EMA has published a Reflection Paper on Good Manufacturing Practice and Marketing Authorisation Holders summarizing various MAH GMP-responsibilities.

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17.02.20

France Takes Further Steps Regarding Medical Cannabis

The French National Agency for Medicines and Health Products Safety carries on the work on medical cannabis started in 2018 and has now published a dossier on cannabis for medical use.

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