On April 26, 2022, was published in the Official Gazette the Exempt Resolution N°273 issued by the Institute of Public Health on February 11, 2022, which approves the technical guide containing the guidelines and orientation for the conduct of clinical studies with biological products.
This technical guide addresses the structure and requirements for the conduct of a local clinical study with investigational biological drugs, providing a general overview on this matter. To this end, the guide delves into the quality information required, non-clinical and clinical development, Good Manufacturing Practices (GMP) considerations for this type of production and the authorization of manufacturing establishments.
In order to carry out a clinical study with biological products, including advanced therapies, it is necessary to have a sanitary authorization from the laboratory in charge of the production of the drug to be investigated, and to have all the documents with the quality information and the pre-clinical information of the product under investigation. With this information, the evaluation of the clinical study can be requested at the Institute of Public Health (ISP).
Once the procedure has been submitted to the ISP, and within the framework of the evaluation carried out by its professionals, the compliance with GMP by the producing laboratory will be verified, considering the possibility of carrying out an inspection visit, according to the risk assessment, the type of product and the development phase, among other aspects.