GMP News - Pharmaceutical Development / Clinical Trials / GCP

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FDA Issues Draft Guidance for Cannabis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 The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities than other drug developers.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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05.08.20

Brexit is approaching: Regulations for Pharmaceuticals defined

The European Commission has published a communication to prepare for the end of the transition period. There are also indications for the pharmaceutical sector.

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21.07.20

Regulatory Authorities worldwide work more closely together because of COVID-19

Regulatory authorities around the world want to work together more closely on the basis of Covid-19 and have identified three areas for this: research during pregnancy, medicines in clinical trials and monitoring of vaccines. Read more here.

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02.07.20

Impact of COVID-19 on EudraVigilance Reporting and Labeling

The European Commission, the HMA and the EMA released a Q&A document on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document includes flexible approaches for adverse reactions reporting and labeling.

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01.07.20

MHRA and FDA release Joint Paper on Data Integrity in Clinical Trials

GCP Inspectors from the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the US FDA have published a joint paper on data integrity in global clinical trials.

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