A targeted stakeholder consultation on amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities has been published on the EC website. The Regulation outlines the practical details on the performance of pharmacovigilance activities to be respected by MAHs, national competent authorities and the EMA.
The EMA and the European Commission have agreed to further extend the pilot on signal detection in EudraVigilance by marketing authorization holders until the end of 2022. MAHs with APIs included in the EMA list of active substances and combinations involved in the pilot should continue to monitor them in EudraVigilance.
The EMA supports recommendations for the use of global track & trace systems to mitigate the risk of drug shortages and fight against falsified medicines. To date, track & trace systems have been designed and implemented with a local or regional focus, without taking into account whether they can exchange information with other systems.
Deviations and CAPA are still important issues during inspections. Inspectors' summaries of their observations show that things do not always work as they should. This also applies to root cause investigations.
During an action week coordinated by INTERPOL against illegal internet trade checks led to the discovery of very large numbers of fake and illicit drugs. Overall the operation resulted in the seizure of around 9 million medical devices and illicit pharmaceuticals.
Even though the USP has no direct force of law, certainly not in Europe, interesting points for use in risk-based supplier qualification programmes can be found in a newly proposed USP chapter.
Data integrity issues continue to be a focus of FDA inspections. Significant problems with data proving the safety, efficacy and quality of manufactured medicinal products were among the reasons for the Warning Letter to the Chinese company BBC Group Limited.
The updated EMA document "Regulatory Q&A on herbal medicinal products" contains several revised Q&As including the Q&As regarding the requirements for the simplified registration procedure.
Due to the Corona pandemic, there were supply shortages of medical device products in the USA. To get these shortages under control in the future, the FDA gets expanded power. What is planned?
Following a draft version, the EMA has now published the final guideline, which describes what documentation is required on the subject of quality for combination products in order to gain and/or maintain a marketing authorization. The guideline consists of 22 pages with 10 chapters.