COVID-19 Survey by the EU Commission.
As the COVID-19 pandemic continues to impact everyday life throughout the World, a wide variety of companies are on the frontline, developing different resources to combat coronavirus. In order to support these companies, the European Commission is conducting a survey. A few weeks back, the Commission launched a strategy focused on supporting the approval of 5 new COVID-19 Drugs by the end of 2021.
Following the strategy, this survey aims to understand the needs of the companies developing / repurposing treatments in response to the pandemic.
The EU Commission is asking for the following information
- Information about COVID-19 therapy being developed by the company.
- Type of Product
- Product Progress Stage
- Number of Member States involved
- Expected dates of filing approvals
- Details of Regulatory Support they need - Respondents can select multiple types of support such as free scientific advice, fast-track clinical trial approvals and shortened market access procedures.
As well as these options, the survey collects more information on manufacturing plans where outsourcing is a possibility. The Commission is also concerned about manufacturing bottlenecks that can affect the demand and supply within the EU. On the regulatory side, the respondents are asked to provide information on Intellectual Property registrations' status.
It’s clear that the European Commission is keen to identify any challenges and additional support these companies might require. Litigation, disputes, and regulations are the top 3 challenges faced by manufacturers.
To complement this assistance from the European Commission, our experts at Med-Di-Dia and Global Regulatory Services Limited extend our hands to offer a wide range of regulatory services.
For any medical/medical device regulatory support, please feel free to connect with us!
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The survey is open until 25 June 2021, but because of the urgency to cope with COVID-19, the EU aims at receiving responses as soon as possible. The Spanish Agency of Medicines and Medical Products (AEMPS) shared details of the survey.