October 6, 2020
European Pharmaceutical Industry – Regulatory Updates

As we all aware, COVID-19 pandemic resulted in the suspension of regular on-site inspections and as the world is slowly coming out of COVID-19 restrictions, Health Agencies are eying on resuming the on-site inspections. In the same context, Swissmedic (the Swiss Agency for Therapeutic Goods) has resumed regular on-site inspections considering the measures of hygiene, social distancing, and the tracing of COVID-19 infections.

Before the inspections, companies are required to complete a questionnaire to confirm the protective measures for inspections. Swissmedic or the regional Medicines Inspectorate will define the exact process of inspection. If inspections are to be carried out on-site, the company being inspected must organize the necessary precautions for the inspection.

On the other hand, Denmark extends COVID-19 drug preparedness rules until December 31, 2020. According to the Danish Minister of Health, emergency rules intended to prevent COVID-19 causing drug shortages will be extended until the end of the year 2020.

The rules provide the Danish Medicines Agency (DMA) the power to oblige companies to submit information on their stock levels. Based on the data, DMA may ask companies to either increase supplies or reallocate medicines and devices to the areas where there is a shortage.

Another Regulatory update is from the European Medicines Agency (EMA) as it is all set to revise Global Clinical Practice (GCP) guidance. As per the update, the EMA is helping ICH to ensure that the feedback of European patients and healthcare professionals are taken into consideration in the ongoing revision of the ICH E6 GCP guideline.

The revised guideline is expected to meet the needs of those participating or conducting clinical trials. It also provides more responsiveness to advancements in the clinical trial design. 

While there are many updates to be discussed or to be considered, the above mentioned are a few major ones from the European pharmaceutical industry. Manufacturers who are planning to strategize their EU market-entry, are advised to keep track of the updates and take a right Regulatory pathway for compliance. Stay informed. Stay compliant.