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Home > Blog > Regulatory Affairs

How to proceed with an active ingredient that can be effective in the management of SARS-CoV-2 respiratory infection

Although numerous clinical trials are underway, there is currently no evidence from controlled clinical trials to recommend a specific treatment for SARS-CoV-2. Therefore, the Spanish Agency for Medicines and Healthcare Products (AEMPS) is continuously monitoring with experts from European agencies, the EMA and other agencies outside the EU all data related to the use of medicines for the treatment or prophylaxis of respiratory infection by SARS-CoV-2.

In this context, and even if other options exist, it is recommended to prioritize the possibility of conducting clinical studies so that, while offering a plausible treatment alternative, they generate useful knowledge since, to date, there are only partial, preliminary, sometimes only in vitro, or even contradictory data on the efficacy of one or another product.

The priority objective is to be able to collect and process in the best way all the information that is being generated, to be able to monitor continuously all this information of the uses of the medicines that are being used as treatment.

In addition, the review of the stock and supplies is becoming necessary to avoid current and future shortages both for this pathology and for other indications in the case of already authorised drugs. The importance of reporting all suspected adverse reactions to the corresponding Autonomous Centre for pharmacovigilance or through the electronic form available at www.notificaram.com is also recalled.

At Azierta, we have a team of multidisciplinary experts ready to help you in any of these stages, speeding up the process as much as possible.  Contact us. 

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