Advanced Therapy Medicinal Products

Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004... 

II. Extemporaneous preparations involving specific risks, such as complex aseptic handling and preparation with hazardous substances. Involved in this category is aseptic handling with most antineoplastics, medication cartridges, radiopharmaceuticals, biological or advanced therapy medicinal products (ATMP s). 

A number of clinical trials show promising results (see Table 2). In the past few years, it has become increasingly clear that for each disease, the development of a particular and specific gene transfer method in connection with a particular treatment approach will probably be necessary. The first standard use of an approved gene transfer medicinal product is to be expected within the next seven years since approximately 1% of the clinical gene therapy studies are in an advanced stage of phase II or phase III clinical trial. 

Volume 2 - Notice to applicants and regulatory guidelines for medicinal products for human use and specific rules for medicinal products for paediatric use, orphan, herbal medicinal products and advanced therapies (mentioned in Sect. 35.4.3)... 

Large-scale production and purification of gene therapy vectors is critical in advancing the clinical utility of this new class of medicine. Linder ideal circumstances, a highly purified vector stock should be manufactured with a relatively stable shelf-life, in a dosage form that is easy to dispense and ultimately administer to the patient. The ideal system does not cuirently exist for any of the vectors used in clinical trials. ... 

Veterinarians have many different tools, products, and options for the treatment of disease. Medicines, such as antibiotics, urinary acidifiers, anthelmintics, steroids, and pain relievers, may be administered by mouth or injection. Intravenous fluids, oxygen therapy, surgery, and many other procedures are performed by veterinarians in small private clinics. More advanced treatments such as the implantation of pacemakers, hip replacements, or cataract removal are performed by veterinarians in university veterinary hospitals or specialized clinics. 

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