Introduction
The topic of pharmaceutical regulation and pharmaceutical development is a field of broad scope. TheraGenesis staff has broad and many years of experience in the realization of pivotal pharmaceutical clinical devlopment programs involving several thousands of patients. These programs have lead to the successful market introduction of inovative products on a global scale.
Having said this, TheraGenesis is committed and enthusiastic about the devlopment of pharmaceutical products. Over the last 20 years, we have supported numerous pharmaceutical manufacturers on clinical programs designed to address specific scientific hypotheses involving hundreds of patients. Should your devlopment plans be consistent with such scope of investigation, we would be excited in a dialog and are convince of our competenicies to fulfill your needs.
Regulations
Given the broad scope of pharmaceutical regulation, we provide below a series of links to enable you to deepen your understanding of the regulatory requirements surrounding pharmaceutical development. Potentially important for our potential customers is a presentation of the definition of a pharmaceutical product as follows:
DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Community code relating to medicinal products for human use (last amended 12 December 2006)
TITLE I
DEFINITIONS
Article 1
For the purposes of this Directive, the following terms shall bear the following meanings:
2. Medicinal product:
(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
3. Substance:
Any matter irrespective of origin which may be:
- human, e.g. human blood and human blood products;
- animal, e.g. micro-organisms, whole animals, parts of organs, animal
- secretions, toxins, extracts, blood products;
- vegetable, e.g. micro-organisms, plants, parts of plants, vegetable secretions, extracts;
- chemical, e.g. elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis.
4. Immunological medicinal product:
Any medicinal product consisting of vaccines, toxins, serums or allergen products:
(a) vaccines, toxins and serums shall cover in particular:
(i) agents used to produce active immunity, such as cholera vaccine, BCG, polio vaccines, smallpox vaccine;
(ii) agents used to diagnose the state of immunity, including in particular tuberculin and tuberculin PPD, toxins for the Schick and Dick Tests, brucellin;
(iii) agents used to produce passive immunity, such as diphtheria antitoxin, anti-smallpox globulin, antilymphocytic globulin;
(b) ‘allergen product’ shall mean any medicinal product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent.