October 3, 2025
Express registration of medicines in the USA
In the United States, it has become possible to register medicines using an accelerated system, where applications from pharmaceutical companies will be considered in one to two months. The US Food and Drug Administration (FDA) will launch a new mechanism.
The massive reduction of staff at the FDA, which in turn led to delays in the work of the regulator was the impetus for the implementation of this initiative.
According to the new system, it will be necessary to provide data on the chemical composition, manufacturing technology, quality control, and labeling of the medicinal product 60 days before submitting the application.
Next, the pharmaceutical company receives a voucher, which allows it to create a single expert group consisting of scientists and doctors who meet for one day. Prior to this, the approval procedure included the following steps:
- Receipt of documents from the pharmaceutical company;
- Data verification;
- Manufacturing site inspection;
- Making a decision.
The process took up to a year.
However, not everyone will receive vouchers, but only those manufacturers who provide assistance in dealing with crises in the US healthcare system, participate in the creation of innovative treatment methods, fill shortages and increase the production of medicines in the country. The voucher will be issued either for a specific drug or for any product that the company chooses from its portfolio.
The voucher is valid for two years from the date of its issuance. Sale to third parties is prohibited.
ts of the drug that have yet to be revealed.”
