How are FDA Inspections and Applications impacted by COVID-19 Restrictions?
The FDA has published a Q&A document with respect to inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products.
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 The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities than other drug developers.
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.
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.
Pharmacovigilance Audits and Inspections during COVID-19
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) released a Q&A document to address challenges arising from the COVID-19 pandemic. The document is updated continuously and includes new Q&As relating to pharmacovigilance activities like CAPAs, Audits and Remote-Inspections.
FDA offers online courses for the pharmaceutical industry
The FDA offers diverse online material as part of their CDERLearn Training and Education Program. A special section contains courses for the pharmaceutical industry.
In order to ensure a smooth and efficient cooperation between the authorities and marketing authorisation holders even in the times of Covid-19, the documentation and templates to facilitate the handling of marketing authorisations have now been bundled, listed and published on the website of the HMA (Heads of Medicines Agencies).
In July, new topics were added to the question and answer catalogue "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC".
Is an Update of the QPPV´s Contact Details a Variation?
The CMDh and CMDv recently published a revised version of the Q&A paper regarding variations including a new question on how to notify about an update of the QPPV´s contact details.
CEPs: What Applicants and Authorisation Holders should know!
Due to the corona pandemic, many processes and regulations are currently in change - information regarding the current procedures for applying for CEPs is listed on the EDQM website.
The Q&A document on variations entitled "Q&A - List for the submission of variations according to Commission Regulation (EC) 1234/2008" of the CMDh and CMDv was updated again in May 2020.