Summaries of regulatory development related to PCS

Regulatory requirements differ according to type, indication, route of application, etc., of the chemical or drug candidates. The requirements attached below should be regarded as being indicative only and are examples for certain drug candidates; please consult the respective regulations, publications and text books.

The Preclinical safety program - Regular - ICH M3(R2) is the basis for further regulatory requirements.

For biologics, the requirements are partly somewhat different, as the tested species must be shown to be response to treatment, which is of lesser importance for testing of normal small molecules. Basically, the following types of biologics are distinguished:

• Pure biologics (presentation Preclinical safety program - Pure biologics)
• Biologics in combination with non-biologic molecules (presentation Preclinical safety program - Biologics in combination), where the requirements of pure biologics are complemented by further requirements

Special requirements exist also for testing of drug candidates intended for oncology indications (presentation Preclinical safety program – Oncology, particularly, if the group of patients is terminally ill and if available drugs have no significant effects. Thus, these patients have a very limited life expectance and can only gain by novel treatment options.

Requirements are also different according to the envisaged route of application. In particular, systemic exposure resulting from dermal application (presentation Preclinical safety program – Dermal) may be low and local effects at the application site might prevail. However, transdermal delivery of drugs is aiming at high systemic exposure and follows e.g. the normal guidelines for delivery of small drugs via different routes (see above) with special focus on the topical application site.

For further development summaries see e.g. also the presentation Pre-clinical toxicity of CNS drugs as of slides 64 ff.