Regulatory Updates in the European Pharmaceutical Industry
As we all know, the COVID-19 pandemic forced the suspension of routine on-site inspections, and now that the world is slowly easing its COVID-19 limitations, health agencies are considering resuming the inspections. Swissmedic (the Swiss Agency for Therapeutic Goods) has resumed routine on-site inspections of hygiene, social distancing, and the tracing of COVID-19 infections in the same sense.
Companies must fill out a questionnaire prior to the inspections to validate the security measures in place before the inspection. The exact inspection process will be described by Swissmedic or the regional Medicines Inspectorate. If inspections are to be conducted on-site, the company being inspected must arrange for the appropriate safety measures.
Denmark, on the other hand, has extended the COVID-19 drug readiness regulations until December 31, 2020. Emergency regulations designed to avoid COVID-19-related drug shortages will be extended until the end of 2020, according to the Danish Minister of Health.
The rules give the Danish Medicines Agency (DMA) the authority to compel companies to request stock-level details. DMA can ask companies to increase supplies or reallocate medicines and devices to areas where there is a shortage based on the data.
Another regulatory clarification comes from the European Medicines Agency (EMA), which is planning to amend its guidelines on Global Clinical Practice (GCP). The EMA is assisting the ICH in ensuring that the input of European patients and healthcare professionals is taken into account in the ongoing revision of the ICH E6 GCP guideline, according to the update.
The updated guidance should consider the needs of those involved in or conducting clinical trials. It also allows for greater responsiveness to changes in clinical trial design.
Although there are several updates to be considered, the ones mentioned above are a few of the most important from the European pharmaceutical industry. Manufacturers preparing to enter the EU market should stay up to date with the latest developments and choose the appropriate regulatory pathway for compliance.
- Danish Medicines Agency - DMA
- Global Clinical Practice - GCP
- Medicines Agency - EMA
- On-site Inspections
- Regulatory Affairs
- Swissmedic.
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