Two new regulatory guidelines from the European Medicine Agency – EMA will come into effect in June 2009.
One guideline is focusing on plans for and execution of clinical development programs for allergen specific immunotherapy. Another guideline will focus on production and quality issues.

GUIDELINE ON THE CLINICAL DEVELOPMENT OF PRODUCTS FOR SPECIFIC IMMUNOTHERAPY FOR THE TREATMENT
OF ALLERGIC DISEASES
(CHMP/EWP/18504/2006)

This Guideline is intended to address issues of study design, efficacy and safety for allergen products (i.e. products based on active substances of e.g. allergen extracts, recombinant allergens, purified native allergens, modified allergens etc.) being developed for specific immunotherapy of allergic diseases (e.g. the long-term treatment and management of allergic conditions like rhino-conjunctivitis and allergic reactions to insect venoms).
Guideline.pdf

GUIDELINE ON ALLERGEN PRODUCTS: PRODUCTION AND QUALITY ISSUES
(CHMP/BWP/304831/2007)

This Guideline lays down the quality recommendations for allergen products of biological origin, including allergen extracts derived from natural source material and allergens produced through recombinant DNA technology, used for specific immunotherapy (SIT) or in vivo diagnosis of immunoglobulin E (IgE)-mediated allergic diseases.
Guideline.pdf

Update on the European Pharmacopeia from the European Directorate for the Quality of Medicines (EDQM)
will go into action during 2009