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.
Again, the catalogue with "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC" issued by the EC, HMA and EMA has been updated. It now includes the facilitated handling of existing marketing authorisations together with the handling of marketing authorisation procedures in times of Covid-19.
The MHRA GVP inspectorate recently published their latest pharmacovigilance inspection metrics report. The report includes remote inspections and lists critical findings in relation to risk management, the quality management system and the provision of information for inspections.
What Marketing Authorisation Holders need to know now about their Registrations
On 10 April 2020, the European Medicines Agency (EMA) together with the Heads of Medicines Agencies (HMA) and the European Commission (EC) published a first version of the document "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC", which is continuously updated and adapted.
The USP Cannabis Expert Panel has published an article on the quality requirements for medical cannabis in the Journal of Natural Products. The article describes the appropriate use of USP General Chapters related to chromatographic methods and controls for contaminants.
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.