GMP News - Regulatory Affairs

08.09.21

ICH publishes Guideline Q13 on Continuous Production

End of July 2022, the ICH (International Council for Harmonisation) published the draft guideline on continuous manufacturing, which had been awaited for two years. In addition to batch definitions, the document describes three different continuous manufacturing approaches and provides guidance on control strategy and approval issues.

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01.09.21

EMA and FDA update Principles for Parallel Scientific Advice in the Marketing Authorization Process

Scientific advice and recommendations from regulatory authorities are usually of great benefit for specific medicines in the development phase. The principles for this have recently been updated by the U.S. and European regulatory authorities. Read here how parallel scientific advice from the EMA and the FDA works and what benefits it brings to the approval process.

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26.08.21

Clinical Trials: Application of the CTR confirmed as of 31 January 2022

It is official now: the EU Commission has confirmed the full functionality of the Clinical Trials Information System in the Official Journal of the EU. This means that the Clinical Trials Regulation 536/2014 (CTR) will become applicable on 31 January 2022. What are the GMP / GCP changes associated with this?

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26.08.21

What is Similarity?

The EMA published the final reflection paper on "Similarity". The paper shows how statistics should be used in drug development when a comparative assessment of quality attributes (QAs) needs to be made for pre- and post-manufacturing changes, biosimilar development as well as generics´ development.

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25.08.21

FDA Publishes New Near Infrared (NIR) Guidance

Near infrared (NIR) analytical procedures are widely used in the pharmaceutical industry for identification testing and assay measurements and for monitoring and controlling manufacturing processes. In this context, the U.S. Food and Drug Administration (FDA) has published a new Guidance for Industry entitled Development and Submission of Near Infrared Analytical Procedures.

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11.08.21

FDA Analyses Products from Amazon and Finds Potentially Harmful Drug Ingredients

The U.S. Food and Drug Administration (FDA) has purchased different products intended for sexual enhancement and weight loss offered for sale on amazon's website. In subsequent laboratory analysis, it was determined that all tested products contain undeclared and potentially harmful drug ingredients. In a letter dated July 26, 2021, sent to Amazon CEO Andy Jassy, the FDA requires Amazon to take measures to prevent such violations in the future.

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11.08.21

Northern Ireland: EU continues to look for Solutions - with interesting Forms of Documents

Are you familiar with a "non-paper"? This is the name given by the EU Commission to a new document that describes proposed solutions for the practical handling of problems within the framework of the Northern Ireland Protocol.

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04.08.21

US Congress is concerned about FDA Inspection Backlog

In a letter sent directly to Janet Woodcock, FDA, the Congress of the United States expresses its concerns about a backlog of pharmaceutical manufacturing facility inspections and human drug applications.

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29.07.21

New WHO Draft on GMP for IMPs

Last year the WHO published draft documents on "Good manufacturing practices for investigational products" and "Good practices for research and development facilities". After consolidation of comments received and review of feedback, revised versions of the two guidelines have now been published for a second round of public consultation. Read more about WHO´s revised guideline on GMP for IMPs.

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29.07.21

EMA Drafts on Quality Requirements for IMPs

The EMA has published two draft guidelines on the quality requirements for IMPs (small and large molecules). According to the Agency, the documents are to be seen in connection with the Clinical Trials Regulation (EU) No. 536/2014 which is expected to become applicable in January 2022.

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29.07.21

New WHO Draft on GxP for Development

Last year the WHO published draft documents on "Good manufacturing practices for investigational products" and "Good practices for research and development facilities". After consolidation of comments received and review of feedback, revised versions of the two guidelines have now been published for a second round of public consultation. Read more about WHO´s revised guideline on GxP for Development.

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27.07.21

CJEU Judgement on OTC Medicines

In a recently published ruling, the Court of Justice of the European Union (CJEU) decided that a medicinal product not subject to medical prescription in one Member State may not automatically be placed on the market in another Member State. Rather, the medicinal product may only be placed on the market in a Member State if the competent authority of that Member State or the EU Commission has granted its marketing authorisation.

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21.07.21

The End for the Rabbit Test - only Alternative Methods in 5 Years

Following its 170th meeting the Commission of the European Pharmacopoeia announced that after a defined transition period the pyrogen rabbit test will be completely replaced.

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21.07.21

Updated Templates for Reporting Nitrosamine Contamination to Regulatory Authorities

Marketing authorisation holders in Europe must evaluate their chemically synthesised or biological medicinal products with regard to nitrosamine impurities and, if necessary, carry out confirmatory testing. Detection of nitrosamines has to be reported. Read more here about which templates must be used for reporting nitrosamine impurities.

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14.07.21

Q&A Document on Nitrosamine Impurities Updated

The latest revision of the EMA's question and answer document on nitrosamine impurities in medicinal products includes clarifications of some important issues. Read more here about the requirements for reporting nitrosamine impurities to regulatory authorities and the current deadlines for this.

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