GMP News - Pharmaceutical Development / Clinical Trials / GCP

10.02.21

FDA Plans for new (GMP) Guidance in 2021 - CDER provides Information

What are the FDA's plans regarding new guidances for the calendar year 2021? An answer to this question is provided by the Center for Drug Evaluation and Research (CDER) in their list of planned and / or to be revised guidance documents. On five pages, comprising 18 individual categories, these documents are presented.

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04.02.21

Modern Vaccines and Platform Technologies - Explained in an Understandable Way

Questions reaching us on the subject of COVID-19 vaccines, their development, approval and production, and on modern platform technologies used are answered in a summary.

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08.12.20

New FDA Guidance on Cellular and Tissue Products (HCT/Ps) published

During  2020, the FDA updated and expanded its series of guidelines on the topic of cell and tissue products with a revised version of the Guideline Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.

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08.12.20

FDA publishes Information and Reviews of Biological Research Projects

In addition to the publication of a large number of guidelines and supporting documents in the field of cell and tissue products, the FDA also provides insights into the biological research projects of its scientists on its website.

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08.12.20

FDA explains Background of Emergency Use Authorizations related to COVID-19 Vaccines

Recently, the FDA published a Q&A Paper on their website that answers the most common questions about the emergency approval of COVID-19 vaccines and explains the underlying process.

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25.11.20

EMA - Public Meeting on COVID-19 Vaccines

Due to the great public interest and the varied discussions, EMA organises a public meeting on Covid-19 vaccines and the role of EMA in the approval process, which all interested citizens can attend via live broadcast.

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25.11.20

Covid-19: Swissmedic adapts Inspections

Swissmedic inspections may be carried either out on-site, (partly) by means of remote assessments or at a later point in time.

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18.11.20

Does GMP apply to Development?

In view of the recent need for the fast development of medicinal products for COVID-19, the World Health Organization (WHO) published a new guideline on Good Manufacturing Practice (GMP) for development batches. According to the WHO, there are currently no regulatory guidelines available which address this matter.

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11.11.20

WHO Draft Document on GMP for IMPs

In view of recent experiences from inspections carried out for COVID-19 therapeutics, the World Health Organization (WHO) published a new working document entitled "GOOD MANUFACTURING PRACTICES FOR INVESTIGATIONAL PRODUCTS".

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09.09.20

USP publishes draft of new chapter <1220> Analytical Procedure Life Cycle

The USP published the long awaited draft of the new chapter on the Lifecycle of Analytical Methods in the Pharmacopoeal Forum.

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12.08.20

Patient Safety Still the Main Reason for Reporting of Serious Breaches

The annual metrics report for GCP referrals has been published by the MHRA. In 2019, the MHRA received a total of 112 serious breach notifications.

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12.08.20

FDA Issues Draft Guidance for Cannabis

The FDA issued a new guideline entitled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research”. The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities than other drug developers.

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06.08.20

EMA Clarifies Investigators Responsibilities Regarding the eCRF

The EMA has updated the Q&As on their Good Clinical Practice (GCP) page. In particular, a new Q&A Nr. 13 clarifies the responsibilities of sponsors and investigators regarding data entered into the eCRF and PI oversight. 

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06.08.20

New Version of the Q&As Applying to Clinical Trials

The European Commission (EC) published an updated Version 2.4 of the Questions & Answers relating to the Clinical Trials Regulation.

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06.08.20

Brexit: Sponsors Need to Establish an EU-QP

Sponsors of EU clinical trials, where the QP is currently located in the UK, need to establish an EU-QP by the end of the transition period. In addition the sponsor of a clinical trial or a legal representative must be established in the EU. Read more here.

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