Hedley Rees' Expert Statement on SARS-CoV-2 injections, Written December 17, 2021: PART 2
Licensing drugs
For those who missed PART 1, here it is:
THE PROCESS OF LICENSING
The process consists of licensing companies to undertake clinical studies in humans, and, if successful, licensing the company to sell the approved product(s) under strict terms of the license.
The licenses are awarded by the competent authority responsible for medicines and healthcare products in each country or region. In the United States, it is the FDA (we will use the US as an example, but all are similar or the same).
The license to run a clinical trial is known as a Clinical Trial Application.
The application must include an investigational medical product dossier (IMPD), with details of the supply chain that will be employed to manufacture clinical trial supplies.
1. Preclinical development and Preclinical development supply chain
Patients receive injections that are produced by the supply chain, so it is crucially important that safety testing is carried out on the batches produced.
The diagram below shows the precli…