Table 1 Types of Regulatory Documents for Allergen-Specific Immunotherapy

• Regulation No. 726/2004/EC laying down Community Procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a EMA. OJ 2004;136:1-33.

• Regulation No. 1901/2001/EC on medicinal products for pediatric use and amending Regulation EEC No. 1768/92, Directive 2001/83/EC, and Regulation No. 726/2004/EC OJ 2006;378:1-19.

• European Pharmacopeia, Monograph on allergen products. 01/2010:1063

B

• Directive 2001/83/EC of the European Parliament and of the Council on the community code relating to medicinal products for human use. OJ 2004;1,341:67-112.

• Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations, and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. OJ 2001;1,121:24-44.

• Commission Directive 2003/63/EC amending Directive 2001/83/EC. OJ 2003/1.159:46-94.

• Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. OJ 2003;262:22-26.

C

• EMA Guideline on Allergen Products: Production and Quality Issues. 2008. EMEA. CHMP/BWP/30483!/2007

• Referring to both allergen extracts (and their classification in homologous groups) and allergens produced trough recombinant technology

• EMA Note for Guidance on Preclinical Pharmacological and Toxicological Testing of Vaccines. 1998/CPMP/SWP/465/95

• ICH Topic M3 (R2). Note for guidance on non-clinical safety studies for the conduct of Human clinical trials and marketing authorization for pharmaceuticals. 2009. CPMP/ICH/286/95

• ICH Topic E6 (R1). Note for guidance on GPC. 2002.CPMP/ICH/135/95

• ICH Topic E9. Note for guidance on statistical principles for clinical trials. 1998.CPMP/ICH/135/95

• Points to consider on application with: 1. Meta-analyses; 2. One pivotal study. 2001.CPMP/EWP/2330/99

• EMA Guideline on the Clinical Development of Products for SIT for the treatment of allergic Diseases. 2008.CHMP/EWP/18504/2006

• EMA/PDCO Standard Paediatric Investigation Plan for Allergen Products for Specific Immunotherapy. EMA/PDCO/737605/2009. Revision 2, 3-3-2010.

D

• Allergen immunotherapy: therapeutic vaccines for allergic diseases. A WHO Position Paper [6]

• Recommendations for standardization of clinical trials with allergen-specific Immunotherapy for respiratory allergy. A statement of the World Allergy Organization Task Force [7]

• Sublingual immunotherapy. WAO Position Paper [8]

• EAACI Immunotherapy Position Paper [9]

• Allergen immunotherapy. A practice parameter. Third Update [10]

• Allergen immunotherapy in children. An EAACI position statement [11]

• The CONSORT statement checklist in allergen specific immunotherapy. A GA2LEN paper [12a, 12b]